Trial Outcomes & Findings for Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (NCT NCT04805671)
NCT ID: NCT04805671
Last Updated: 2024-02-06
Results Overview
To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID-19 in participants at high risk of disease progression. Hospitalization is defined as ≥24 hours of acute care in a hospital or acute care facility (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities). All-cause death is defined as death for any reason from Day 1 (postdose) through Day 29.
TERMINATED
PHASE2/PHASE3
399 participants
Through Day 29
2024-02-06
Participant Flow
Participant milestones
| Measure |
ADG20 IM
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
201
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
190
|
191
|
Reasons for withdrawal
| Measure |
ADG20 IM
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Overall Study
Death
|
2
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
|
Overall Study
Study terminated prematurely; participants active in the study discontinued from the trial.
|
178
|
177
|
Baseline Characteristics
Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
Baseline characteristics by cohort
| Measure |
ADG20 IM
n=198 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=201 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
53 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
198 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
183 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through Day 29Population: Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants.
To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID-19 in participants at high risk of disease progression. Hospitalization is defined as ≥24 hours of acute care in a hospital or acute care facility (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities). All-cause death is defined as death for any reason from Day 1 (postdose) through Day 29.
Outcome measures
| Measure |
ADG20 IM
n=169 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=167 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of COVID-19 Related Hospitalizations or All-cause Death
|
8 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Through day 29Population: Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received. Participants with more than one AE were only counted once.
Proportion of participants with at least one treatment emergent AE
Outcome measures
| Measure |
ADG20 IM
n=192 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of Treatment-emergent Adverse Events
|
47 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: Through Day 4Population: Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received.
Proportion of participants with at least one solicited injection site reaction
Outcome measures
| Measure |
ADG20 IM
n=192 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of Solicited Injection Site Reactions
|
25 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Through Day 29Population: Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received.
Proportion of participants with a potentially clinically significant change from baseline in post-baseline laboratory parameters - data presented for any analyte with \>/= 2% in any arm
Outcome measures
| Measure |
ADG20 IM
n=192 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Lymphocytes (10^9/L) - L
|
3 Participants
|
4 Participants
|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Alanine Aminotransferase (U/L) - H
|
6 Participants
|
10 Participants
|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Albumin (g/L) - L
|
0 Participants
|
5 Participants
|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Creatinine (mcmol/L) - H
|
26 Participants
|
23 Participants
|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Creatinine Clearance, Estimated (mL/min/1.73m2) - L
|
15 Participants
|
18 Participants
|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Glucose (mmol/L) - H
|
12 Participants
|
16 Participants
|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Sodium (mmol/L) - L
|
1 Participants
|
4 Participants
|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Urea Nitrogen (mmol/L) - H
|
26 Participants
|
21 Participants
|
|
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
Prothrombin Intl. Normalized Ratio - H
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Through Day 29Population: Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received.
Participants with Potentially Clinically Significant Changes (PCS) From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure) at Any Time Post-Baseline
Outcome measures
| Measure |
ADG20 IM
n=192 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
SpO2 <=93% or Decrease >=3%
|
14 Participants
|
19 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
SBP <=90 mmHg or Decrease >=20 mmHg
|
17 Participants
|
23 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
SBP >=180 mmHg or Increase >=20 mmHg
|
29 Participants
|
26 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
DBP <=50 mmHg or Decrease >=15 mmHg
|
25 Participants
|
26 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
DBP >=105 mmHg or Increase >=15 mmHg
|
24 Participants
|
31 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
HR <=50 bpm or Decrease >=15 bpm [a]
|
78 Participants
|
96 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
HR >120 bpm or Increase >=15 bpm
|
20 Participants
|
25 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
Temp <35 C or Decrease >=1 C [b]
|
60 Participants
|
56 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
Temp >=38 C or Increase >=1 C [c]
|
5 Participants
|
17 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
RR <=8 breaths/min or Decrease >=4 bpm
|
20 Participants
|
25 Participants
|
|
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
RR >=30 breaths/min or Increase >=10 bpm [d]
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Through Day 29Population: Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants.
Proportion of participants with COVID-19-related medically attended visit (telemedicine, physician office, urgent care center, emergency room, hospitalization) or all-cause death through Day 29. In addition to events defined as the primary efficacy endpoint, this endpoint also includes any medically attended visits, in-person, or telemedicine, not specified in the protocol. These include unscheduled in-person or telemedicine visits conducted by the investigator for the purpose of evaluating worsening signs or symptoms attributed to COVID-19 or emergency room, urgent care center or physician office visits, or hospitalization for attention to worsening signs or symptoms attributed to COVID-19, in the opinion of the investigator. Incidence of COVID-19-related medically attended visits or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.
Outcome measures
| Measure |
ADG20 IM
n=169 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=167 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of COVID-19 -Related Medically Attended Visits or All-cause Death
|
9 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Through Day 29Population: Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to WGS-confirmed or suspected non-Omicron SARS-CoV-2 variants.
Proportion of participants with any COVID 19-related emergency room visits, COVID-19-related hospitalization, or all cause death through Day 29. Defined as any stay in a hospital or acute care facility regardless of duration (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities) for attention to worsening signs or symptoms attributed to COVID-19 in the opinion of the investigator or all cause death through Day 29. Incidence of COVID-19-related emergency room visits, COVID-19-related hospitalization, or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.
Outcome measures
| Measure |
ADG20 IM
n=169 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=167 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of COVID-19 -Related Emergency Room Visits, COVID-19-related Hospitalization, or All Cause-death
|
8 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Through Day 29Population: Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants.
Proportion of participants with Severe/Critical COVID-19 or all-cause death through Day 29. All-cause death is defined as death for any reason (from Day 1postdose) through Day 29. Severity is based on the investigator's assessment of severity (eCRF COVID-19 Severity Assessment) per the protocol definitions. Incidence of Severe/Critical COVID-19 or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.
Outcome measures
| Measure |
ADG20 IM
n=169 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=167 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of Severe/Critical COVID-19 or All Cause Death
|
8 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Through Day 29Population: Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants.
Time to sustained recovery (improvement or resolution) of COVID-19 symptoms through Day 29: Defined as the time from the first dose date to the earliest date when sustained improvement or sustained resolution of COVID-19 symptoms is met (as detailed below) through Day 29. COVID-19 symptoms assessed include fever, chills, cough, sore throat, congestion, shortness of breath/difficulty breathing at rest, shortness of breath/difficulty breathing with exertion, muscle or body aches, fatigue, headache, nausea, vomiting, and diarrhea. Loss of taste/smell is excluded from this analysis.
Outcome measures
| Measure |
ADG20 IM
n=169 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=167 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Time to Sustained Recovery Defined as Sustained Improvement or Resolution of COVID-19 Symptoms
|
11 Days
Interval 9.0 to 14.0
|
14 Days
Interval 12.0 to 17.0
|
SECONDARY outcome
Timeframe: Through Day 90Population: Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants.
Defined as death for any reason from Day 1 (postdose). In the overall survival analysis, participants who are alive or lost to follow-up at the time of analysis are censored at the date of last contact.
Outcome measures
| Measure |
ADG20 IM
n=169 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=167 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of All-cause Mortality
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Through Day 29Population: Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants.
Time to sustained resolution of COVID-19 symptoms through Day 29: Defined as time from the dose date to the first date when all of the defined symptoms are scored as absent with no symptom recurrence or new symptoms, except cough, fatigue, and headache which may be mild or absent, through Day 29.
Outcome measures
| Measure |
ADG20 IM
n=169 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=167 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Time to Sustained Resolution of COVID-19 Symptoms as Measured in the Daily COVID-19 Symptom Diary
|
13 Days
Interval 10.0 to 15.0
|
16 Days
Interval 13.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 7 (±1)Population: Modified Full Analysis Set (mFAS-non-Omicron-NP): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline NP sample.
Assessed by RT qPCR From NP (Nasopharyngeal) Samples
Outcome measures
| Measure |
ADG20 IM
n=147 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=149 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL) to Day 7 (±1)
|
-3.61 log10 copies/mL
Standard Error 0.238
|
-3.44 log10 copies/mL
Standard Error 0.224
|
SECONDARY outcome
Timeframe: Through Day 29Population: Modified Full Analysis Set (mFAS-non-Omicron-S): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline saliva sample.
Duration of SARS-CoV-2 viral shedding is defined as time from the dose date to the first date the viral load is not detected, ie, below the limit of detection (LOD), and sustained through Day 29. Participants who do not have the defined event or who discontinue study prior to Day 29 are censored at the earlier date of the last viral load assessment or Day 30. Deaths occurring prior to Day 29 were censored at Day 30.
Outcome measures
| Measure |
ADG20 IM
n=147 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=149 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Duration of SARS-CoV-2 Shedding Assessed by RT-qPCR From Saliva Samples
|
14 Days
Interval 14.0 to 21.0
|
21 Days
Interval 14.0 to 21.0
|
SECONDARY outcome
Timeframe: on Day 7 (+/- 1 Day)Population: Modified Full Analysis Set (mFAS-non-Omicron-NP): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline NP sample.
Proportion of participants with Viral load \>5 (log10 copies/mL) on Day 7 assessed by RT-qPCR from NP sample.
Outcome measures
| Measure |
ADG20 IM
n=148 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=146 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Viral Load >5 (log10 Copies/mL) Based on Nasopharyngeal Sampling at Day 7
|
49 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Days 5, 7, 11, 14, 21, and 29 (saliva)Population: Modified Full Analysis Set (mFAS-non-Omicron-S): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline saliva sample.
Proportions of SARS-CoV-2 viral clearance (Days 3, 5, 7, 11, 14, 21, and 29) assessed by RT-qPCR from saliva samples: In the mFAS-S, the cumulative proportion of participants with viral clearance (viral load not detected and sustained through Day 29) at Days 3, 5, 7, 11, 14, 21, and 29 will be assessed by RT-qPCR from saliva samples. Participants who have died or discontinued study prior to Day 29 are assumed to have no viral clearance.
Outcome measures
| Measure |
ADG20 IM
n=147 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=149 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7)
Participants with Day 11 Samples who achieved sustained viral clearance
|
55 Participants
|
40 Participants
|
|
SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7)
Participants with Day 14 Samples who achieved sustained viral clearance
|
73 Participants
|
62 Participants
|
|
SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7)
Participants with Day 21 Samples who achieved sustained viral clearance
|
98 Participants
|
83 Participants
|
|
SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7)
Participants with Day 5 Samples who achieved sustained viral clearance
|
21 Participants
|
9 Participants
|
|
SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7)
Participants with Day 7 Samples who achieved sustained viral clearance
|
27 Participants
|
19 Participants
|
|
SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7)
Participants with Day 29 Samples who achieved sustained viral clearance
|
123 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Modified Full Analysis Set (mFAS-non-Omicron-S): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline saliva sample.
The AUC from Day 1 through Day 29 was calculated according to the linear trapezoidal rule using the measured SARS-CoV-2 viral load above the lower limit of quantification. No AUC values will be calculated when Day 1 and/or Day 29 values are missing, or if there are more than 3 values missing in the profile.
Outcome measures
| Measure |
ADG20 IM
n=131 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=126 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
SARS-CoV-2 Viral Load AUC Assessed by RT-qPCR From Saliva Samples
|
49.96 log10 copies*day/mL
Standard Deviation 36.54
|
57.60 log10 copies*day/mL
Standard Deviation 37.52
|
SECONDARY outcome
Timeframe: 14 monthsPopulation: Percent of participants who reported at least one TEAE.
An AE is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to the study drug. AEs occurring from when the participant signed the ICF until the Month 14 (EOS) visit or discontinuation from study was recorded
Outcome measures
| Measure |
ADG20 IM
n=192 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of Treatment Emergent Adverse Events
|
75 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 14 MonthsPopulation: Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received. Data presented for any analyte with \>/= 2% in any arm.
A PCS value is defined as any DAIDS grade 4 post-baseline or any increase of 2 or more DAIDS grades post-baseline, except for PCS low creatinine clearance, which is defined as any DAIDS Grade 4 post-baseline or any DAIDS grade shift from 0 to 3. Laboratory parameters not graded by DAIDs will be defined as PCS based on the criteria in the SAP (Appendix K.)
Outcome measures
| Measure |
ADG20 IM
n=192 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Prothrombin Time (sec) - H
|
7 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Lymphocytes (10^9/L) - L
|
3 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Alanine Aminotransferase (U/L) - H
|
6 Participants
|
10 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Albumin (g/L) - L
|
0 Participants
|
5 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Creatinine (mcmol/L) - H
|
26 Participants
|
23 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Creatinine Clearance, Estimated (mL/min/1.73m2) - L
|
15 Participants
|
18 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Glucose (mmol/L) - H
|
12 Participants
|
16 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Sodium (mmol/L) - L
|
1 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Urea Nitrogen (mmol/L) - H
|
26 Participants
|
21 Participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
Prothrombin Intl. Normalized Ratio - H
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 MonthsPopulation: Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received.
Outcome measures
| Measure |
ADG20 IM
n=192 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
DBP <=50 mmHg or Decrease >=15 mmHg
|
25 participants
|
26 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
SBP <=90 mmHg or Decrease >=20 mmHg
|
17 participants
|
23 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
DBP >=105 mmHg or Increase >=15 mmHg
|
24 participants
|
31 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
RR <=8 breaths/min or Decrease >=4 bpm
|
20 participants
|
25 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
SBP >=180 mmHg or Increase >=20 mmHg
|
29 participants
|
26 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
HR <=50 bpm or Decrease >=15 bpm [a]
|
78 participants
|
96 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
HR >120 bpm or Increase >=15 bpm
|
20 participants
|
25 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
Temp <35 C or Decrease >=1 C [b]
|
60 participants
|
56 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
Temp >=38 C or Increase >=1 C [c]
|
5 participants
|
17 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
RR >=30 breaths/min or Increase >=10 bpm [d]
|
2 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
SpO2 <=93% or Decrease >=3%
|
14 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 11 monthsPopulation: All participants in the Safety Set who had a valid immunogenicity test result before the dose of study drug, and at least 1 valid result after the dose of study drug; analysis limited to participants who received ADG20 only.
Outcome measures
| Measure |
ADG20 IM
n=137 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Incidence of ADA to ADG20
|
12 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants with any mutation at a monitored position \>/= 15% allele frequency, in the population that had a qualifying (passed QC testing) baseline and post-baseline Whole Genome Sequencing sample.
Post-baseline Treatment-emergent Variations at Amino Acid Positions Associated with Reduced Susceptibility to ADG20 (\>/= 15% Allele frequency); data limited to mutations observed.
Outcome measures
| Measure |
ADG20 IM
n=95 Participants
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=119 Participants
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Genotypic Characterization of Viral Isolates for Reduced Susceptibility to ADG20 (G504 Mutations)
|
3 Participants
|
0 Participants
|
Adverse Events
ADG20 IM
Placebo IM
Serious adverse events
| Measure |
ADG20 IM
n=192 participants at risk
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 participants at risk
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
4.2%
8/192 • Baseline through Month 14
safety analysis set
|
12.0%
24/200 • Baseline through Month 14
safety analysis set
|
|
Infections and infestations
Pneumonia bacterial
|
1.0%
2/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Infections and infestations
Pneumonia
|
0.52%
1/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Infections and infestations
Listeriosis
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Cardiac disorders
Acute myocardial infarction
|
0.52%
1/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Cardiac disorders
Angina unstable
|
0.52%
1/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.52%
1/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.52%
1/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.52%
1/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.52%
1/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.52%
1/192 • Baseline through Month 14
safety analysis set
|
0.00%
0/200 • Baseline through Month 14
safety analysis set
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Nervous system disorders
Syncope
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
General disorders
Sudden death
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/192 • Baseline through Month 14
safety analysis set
|
0.50%
1/200 • Baseline through Month 14
safety analysis set
|
Other adverse events
| Measure |
ADG20 IM
n=192 participants at risk
Participants will be dosed on Day 1 with ADG20 IM
ADG20: Single dose of ADG20
|
Placebo IM
n=200 participants at risk
Participants will be dosed on Day 1 with placebo IM
Normal saline: Single dose of normal saline
|
|---|---|---|
|
General disorders
Injection site pain
|
12.0%
23/192 • Baseline through Month 14
safety analysis set
|
8.0%
16/200 • Baseline through Month 14
safety analysis set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place