Trial Outcomes & Findings for A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection (NCT NCT04602000)
NCT ID: NCT04602000
Last Updated: 2022-07-20
Results Overview
To assess the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1642 participants
Primary outcome timeframe
Up to Day 28
Results posted on
2022-07-20
Participant Flow
For Part 1, participants were screened from 23 study centers in 4 countries and were enrolled from 23 study centers in 4 countries. For Part 2, participants were screened from 60 study centers in 14 countries and were enrolled from 58 study centers in 13 countries.
For Part 1, a total of 371 participants were screened and 327 participants were enrolled (44 screening failures) and randomized. For Part 2, a total of 1,467 participants were screened and 1,315 participants were enrolled (152 screening failures) and randomized.
Participant milestones
| Measure |
CT-P59 40 mg/kg Group (Part 1)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
105
|
111
|
111
|
656
|
659
|
|
Overall Study
COMPLETED
|
97
|
103
|
105
|
618
|
608
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
6
|
38
|
51
|
Reasons for withdrawal
| Measure |
CT-P59 40 mg/kg Group (Part 1)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
3
|
27
|
39
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
2
|
2
|
|
Overall Study
Death
|
0
|
1
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
3
|
4
|
|
Overall Study
Other
|
4
|
1
|
2
|
5
|
4
|
|
Overall Study
Completed Treatment Period but not entered into Follow-up Period
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
Baseline characteristics by cohort
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=105 Participants
CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
CT-P59: CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
|
CT-P59 80 mg/kg Group (Part 1)
n=111 Participants
CT-P59 (regdanvimab), 80 mg/kg by IV infusion once
CT-P59: CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
|
Placebo Group (Part 1)
n=111 Participants
Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once
Placebo: Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
|
CT-P59 40 mg/kg Group (Part 2)
n=656 Participants
CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
CT-P59: CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
|
Placebo Group (Part 2)
n=659 Participants
Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once
Placebo: Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
|
Total
n=1642 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
562 Participants
n=4 Participants
|
576 Participants
n=21 Participants
|
1410 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
225 Participants
n=10 Participants
|
|
Age, Continuous
|
51.0 years
n=5 Participants
|
51.0 years
n=7 Participants
|
52.0 years
n=5 Participants
|
49.0 years
n=4 Participants
|
47.0 years
n=21 Participants
|
49.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
309 Participants
n=4 Participants
|
332 Participants
n=21 Participants
|
802 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
347 Participants
n=4 Participants
|
327 Participants
n=21 Participants
|
840 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
94 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
563 Participants
n=4 Participants
|
569 Participants
n=21 Participants
|
1418 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
55 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not allowed by investigator country regulations
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
147 Participants
n=10 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
25 participants
n=4 Participants
|
32 participants
n=21 Participants
|
57 participants
n=10 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=10 Participants
|
|
Region of Enrollment
South Korea
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
52 participants
n=10 Participants
|
|
Region of Enrollment
North Macedonia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
30 participants
n=4 Participants
|
26 participants
n=21 Participants
|
56 participants
n=10 Participants
|
|
Region of Enrollment
Mexico
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
68 participants
n=4 Participants
|
70 participants
n=21 Participants
|
138 participants
n=10 Participants
|
|
Region of Enrollment
Moldova
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
19 participants
n=4 Participants
|
18 participants
n=21 Participants
|
37 participants
n=10 Participants
|
|
Region of Enrollment
Peru
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
9 participants
n=21 Participants
|
20 participants
n=10 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
43 participants
n=4 Participants
|
47 participants
n=21 Participants
|
90 participants
n=10 Participants
|
|
Region of Enrollment
Romania
|
93 participants
n=5 Participants
|
90 participants
n=7 Participants
|
93 participants
n=5 Participants
|
315 participants
n=4 Participants
|
311 participants
n=21 Participants
|
902 participants
n=10 Participants
|
|
Region of Enrollment
Serbia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
23 participants
n=4 Participants
|
24 participants
n=21 Participants
|
47 participants
n=10 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
14 participants
n=21 Participants
|
24 participants
n=10 Participants
|
|
Region of Enrollment
Ukraine
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
58 participants
n=4 Participants
|
49 participants
n=21 Participants
|
107 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
49 participants
n=4 Participants
|
51 participants
n=21 Participants
|
108 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included)
To assess the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1)
|
4 Participants
|
5 Participants
|
9 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 14Population: ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included)
To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of negative conversion in nasopharyngeal swab specimen based on RT-qPCR up to Day 14
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Day 2
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Day 3
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Day 4
|
2 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Day 5
|
7 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Day 6
|
5 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Day 7
|
8 Participants
|
12 Participants
|
7 Participants
|
—
|
—
|
|
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Day 10
|
19 Participants
|
18 Participants
|
19 Participants
|
—
|
—
|
|
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Day 14
|
23 Participants
|
19 Participants
|
23 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 14Population: ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included)
To evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1)
|
12.75 days
Interval 9.0 to 12.84
|
11.89 days
Interval 8.94 to 12.91
|
12.94 days
Interval 12.75 to 13.99
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 14Population: ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included; Patients who have absent for all symptoms or at least one missing at baseline are excluded.)
To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=95 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=92 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=98 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Time to Clinical Recovery (Part 1)
|
7.18 days
Interval 5.5 to 9.37
|
7.30 days
Interval 5.72 to 9.33
|
8.80 days
Interval 6.88 to 13.09
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: ITT Set - High Risk (defined as all randomly assigned patients to the study drug, who were at high-risk for progressing to severe COVID-19 and/or hospitalization and who met at least 1 of the high-risk criteria)
To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 in high-risk patients
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=446 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=434 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in High-risk Patients (Part 2)
|
14 Participants
|
48 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITT Set (defined as all randomly assigned patients to the study drug)
To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 in all randomized patients
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=656 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=659 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in All Randomized Patients (Part 2)
|
16 Participants
|
53 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: ITT Set - High Risk (defined as all randomly assigned patients to the study drug, who were at high-risk for progressing to severe COVID-19 and/or hospitalization and who met at least 1 of the high-risk criteria; Patient who reported at least 1 symptom at baseline was included)
To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in high-risk patients. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=429 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=406 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2)
|
9.27 days
Interval 8.27 to 11.05
|
NA days
Interval 12.35 to
The median time in Placebo group was not reached as less than 50% of patients achieved clinical recovery and the number of patients achieved clinical recovery in Placebo group was not sufficient to calculate the upper CI.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: ITT Set (defined as all randomly assigned patients to the study drug; Patient who reported at least 1 symptom at baseline was included)
To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in all randomized patients. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=629 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=618 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2)
|
8.38 days
Interval 7.91 to 9.33
|
13.25 days
Interval 11.94 to
The number of patients achieved clinical recovery in Placebo group was not sufficient to calculate the upper CI.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
To evaluate the additional efficacy of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=656 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=659 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2)
|
4 Participants
|
5 Participants
|
9 Participants
|
16 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
To evaluate the additional efficacy of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=656 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=659 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2)
|
4 Participants
|
4 Participants
|
9 Participants
|
15 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
To evaluate the additional efficacy of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=656 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=659 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
To evaluate the additional efficacy of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=656 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=659 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2)
|
7 Participants
|
11 Participants
|
15 Participants
|
37 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
To evaluate the additional efficacy of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=656 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=659 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
To evaluate the additional efficacy of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=656 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=659 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patients With All-cause Mortality (Part 1 and Part 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug; Patient who had positive result confirmed based on the negative threshold at baseline was included)
To evaluate the additional efficacy of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=612 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=618 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2)
|
12.75 days
Interval 9.0 to 12.84
|
11.89 days
Interval 8.94 to 12.91
|
12.94 days
Interval 12.75 to 13.99
|
11.90 days
Interval 9.02 to 12.83
|
13.15 days
Interval 12.97 to 18.8
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 21, and 28Population: ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug; Patient who had positive result confirmed based on the negative threshold at baseline was included)
To evaluate the additional efficacy of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=612 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=618 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
Day 14
|
23 Participants
|
19 Participants
|
23 Participants
|
113 Participants
|
149 Participants
|
|
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
Day 3
|
4 Participants
|
4 Participants
|
3 Participants
|
34 Participants
|
21 Participants
|
|
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
Day 7
|
8 Participants
|
12 Participants
|
7 Participants
|
141 Participants
|
94 Participants
|
|
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
Day 10
|
19 Participants
|
18 Participants
|
19 Participants
|
137 Participants
|
117 Participants
|
|
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
Day 21
|
10 Participants
|
8 Participants
|
9 Participants
|
99 Participants
|
117 Participants
|
|
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
Day 28
|
6 Participants
|
5 Participants
|
5 Participants
|
52 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITTI Set for Part 1 (all randomly assigned patients with confirmed SARS-CoV-2 infection by Day 1 of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included; Patients who had absent for all symptoms or at least one missing at baseline are excluded), and ITT Set for Part 2 (all randomly assigned patients to study drug; Patient who reported at least 1 symptom at baseline was included)
To evaluate the additional efficacy of CT-P59. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=95 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=92 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=98 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=629 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=618 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Time to Clinical Recovery (Part 1 and Part 2)
|
7.18 days
Interval 5.5 to 9.37
|
7.30 days
Interval 5.72 to 9.33
|
8.80 days
Interval 6.88 to 13.09
|
8.39 days
Interval 8.01 to 9.39
|
13.29 days
Interval 12.12 to 15.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 7, 14, 28, and 56Population: ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result (Day 1) of RT-qPCR, who receive a complete or partial dose of study drug) for both Parts.
To assess the serology of SARS-CoV-2 antibody. The proportions of patients positive with IgG or IgM were summarized.
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=101 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=103 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=103 Participants
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=612 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=618 Participants
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgM - Day 28
|
59 Participants
|
77 Participants
|
65 Participants
|
461 Participants
|
493 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgG - Day 1
|
0 Participants
|
6 Participants
|
3 Participants
|
45 Participants
|
35 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgG - Day 7
|
27 Participants
|
32 Participants
|
32 Participants
|
354 Participants
|
322 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgG - Day 14
|
77 Participants
|
82 Participants
|
86 Participants
|
498 Participants
|
509 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgG - Day 28
|
84 Participants
|
94 Participants
|
91 Participants
|
535 Participants
|
548 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgG - Day 56
|
78 Participants
|
85 Participants
|
86 Participants
|
506 Participants
|
532 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgM - Day 1
|
2 Participants
|
6 Participants
|
4 Participants
|
53 Participants
|
55 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgM - Day 7
|
38 Participants
|
43 Participants
|
49 Participants
|
362 Participants
|
332 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgM - Day 14
|
78 Participants
|
82 Participants
|
87 Participants
|
467 Participants
|
491 Participants
|
|
[Virology] Viral Serology for SARS-CoV-2 Antibody
IgM - Day 56
|
39 Participants
|
54 Participants
|
51 Participants
|
407 Participants
|
441 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusionPopulation: PK Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion \[Day 1\] result based on RT-qPCR and who had signed informed consent to participate in a PK sub-study, received a complete dose of study drug, and had at least 1 evaluable post-treatment PK result; If the pre-infusion result at Day 1 was confirmed negative or missing and the Day 2 result was confirmed positive, this patient was also included)
To assess the PK of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=29 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=32 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
[PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1)
|
212460.507 h*μg/mL
Standard Deviation 46724.5556
|
426694.643 h*μg/mL
Standard Deviation 121171.182
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusionPopulation: PK Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion (Day 1) result based on RT-qPCR and who had signed informed consent to participate in a PK sub-study, received a complete dose of study drug, and had at least 1 evaluable post-treatment PK result)
To assess the PK of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=29 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=32 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
[PK] Maximum Serum Concentration (Cmax) (Part 1)
|
1016.6 μg/mL
Standard Deviation 268.97
|
2007.6 μg/mL
Standard Deviation 477.97
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusionPopulation: PK Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion (Day 1) result based on RT-qPCR and who had signed informed consent to participate in a PK sub-study, received a complete dose of study drug, and had at least 1 evaluable post-treatment PK result)
To assess the PK of CT-P59
Outcome measures
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=29 Participants
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=32 Participants
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
[PK] Terminal Half-life (t1/2) (Part 1)
|
403.916 h
Standard Deviation 147.8450
|
453.442 h
Standard Deviation 107.5620
|
—
|
—
|
—
|
Adverse Events
CT-P59 40 mg/kg Group (Part 1)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
CT-P59 80 mg/kg Group (Part 1)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Group (Part 1)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
CT-P59 40 mg/kg Group (Part 2)
Serious events: 6 serious events
Other events: 119 other events
Deaths: 1 deaths
Placebo Group (Part 2)
Serious events: 5 serious events
Other events: 128 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=105 participants at risk
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=110 participants at risk
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=110 participants at risk
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=652 participants at risk
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=650 participants at risk
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/652 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/650 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/652 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/650 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/652 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/650 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/652 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/650 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Infections and infestations
Appendicitis
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/652 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/650 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Infections and infestations
Pneumonia
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/652 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/650 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/652 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/650 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/652 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/650 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/652 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/650 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraocular melanoma
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/652 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/650 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/652 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/650 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
Other adverse events
| Measure |
CT-P59 40 mg/kg Group (Part 1)
n=105 participants at risk
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
CT-P59 80 mg/kg Group (Part 1)
n=110 participants at risk
Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 1)
n=110 participants at risk
Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
|
CT-P59 40 mg/kg Group (Part 2)
n=652 participants at risk
Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
|
Placebo Group (Part 2)
n=650 participants at risk
Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.9%
3/105 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.7%
3/110 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.92%
6/652 • Number of events 6 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
12/650 • Number of events 12 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.9%
3/105 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.7%
11/652 • Number of events 11 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.77%
5/650 • Number of events 5 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Infections and infestations
Cystitis
|
2.9%
3/105 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/652 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.15%
1/650 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.91%
1/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.9%
19/652 • Number of events 22 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
4.8%
31/650 • Number of events 34 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Investigations
Blood creatine phosphokinase increased
|
4.8%
5/105 • Number of events 5 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.1%
14/652 • Number of events 14 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.5%
10/650 • Number of events 10 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Investigations
C-reactive protein increased
|
0.95%
1/105 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.8%
18/652 • Number of events 18 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.5%
10/650 • Number of events 10 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.91%
1/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.2%
8/652 • Number of events 8 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
3.1%
20/650 • Number of events 20 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
3.2%
21/652 • Number of events 21 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.3%
15/650 • Number of events 16 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.7%
3/110 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.1%
14/652 • Number of events 14 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.6%
17/650 • Number of events 18 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.8%
4/105 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.7%
3/110 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.1%
7/652 • Number of events 7 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.4%
9/650 • Number of events 9 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
2/105 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.7%
3/110 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
12/652 • Number of events 12 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.4%
9/650 • Number of events 9 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.95%
1/105 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.7%
3/110 • Number of events 5 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.4%
9/652 • Number of events 10 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.92%
6/650 • Number of events 7 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.7%
6/105 • Number of events 7 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.7%
3/110 • Number of events 5 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
4.4%
29/652 • Number of events 35 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
5.1%
33/650 • Number of events 40 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Nervous system disorders
Dizziness
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.7%
3/110 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/652 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.31%
2/650 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/105 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.7%
3/110 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/652 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.77%
5/650 • Number of events 5 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Vascular disorders
Hypertension
|
0.95%
1/105 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.00%
0/110 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.6%
17/652 • Number of events 22 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
2.2%
14/650 • Number of events 15 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
|
Infections and infestations
Bacteriuria
|
1.9%
2/105 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.46%
3/652 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
0.46%
3/650 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
|
Additional Information
Yun Ju Bae / Head of Clinical Planning 1 Department
Celltrion, Inc
Phone: +82 32 850 4160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER