Trial Outcomes & Findings for A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19 (NCT NCT04646044)
NCT ID: NCT04646044
Last Updated: 2024-03-12
Results Overview
Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Bempegaldesleukin 0.00075 mg/kg
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
15
|
|
Overall Study
COMPLETED
|
5
|
4
|
4
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Bempegaldesleukin 0.00075 mg/kg
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19
Baseline characteristics by cohort
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
n=15 Participants
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
35.3 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
28.2 kg/m2
STANDARD_DEVIATION 4.88 • n=5 Participants
|
26.6 kg/m2
STANDARD_DEVIATION 2.03 • n=7 Participants
|
27.5 kg/m2
STANDARD_DEVIATION 5.13 • n=5 Participants
|
27.8 kg/m2
STANDARD_DEVIATION 4.62 • n=4 Participants
|
27.6 kg/m2
STANDARD_DEVIATION 4.24 • n=21 Participants
|
|
Systolic Blood Pressure (BP)
|
125.4 mmHg
STANDARD_DEVIATION 7.44 • n=5 Participants
|
119.2 mmHg
STANDARD_DEVIATION 15.35 • n=7 Participants
|
125.0 mmHg
STANDARD_DEVIATION 6.28 • n=5 Participants
|
122.3 mmHg
STANDARD_DEVIATION 13.00 • n=4 Participants
|
122.8 mmHg
STANDARD_DEVIATION 11.47 • n=21 Participants
|
|
Diastolic Blood Pressure (BP)
|
80.4 mmHg
STANDARD_DEVIATION 3.21 • n=5 Participants
|
77.4 mmHg
STANDARD_DEVIATION 7.30 • n=7 Participants
|
82.8 mmHg
STANDARD_DEVIATION 5.45 • n=5 Participants
|
78.1 mmHg
STANDARD_DEVIATION 9.60 • n=4 Participants
|
79.1 mmHg
STANDARD_DEVIATION 7.81 • n=21 Participants
|
|
Pulse Rate
|
72.8 beats/minute
STANDARD_DEVIATION 6.98 • n=5 Participants
|
78.0 beats/minute
STANDARD_DEVIATION 6.52 • n=7 Participants
|
79.8 beats/minute
STANDARD_DEVIATION 3.70 • n=5 Participants
|
73.5 beats/minute
STANDARD_DEVIATION 9.30 • n=4 Participants
|
75.2 beats/minute
STANDARD_DEVIATION 7.98 • n=21 Participants
|
|
Respiration Rate
|
15.8 breaths/minute
STANDARD_DEVIATION 1.10 • n=5 Participants
|
16.2 breaths/minute
STANDARD_DEVIATION 0.45 • n=7 Participants
|
16.6 breaths/minute
STANDARD_DEVIATION 0.89 • n=5 Participants
|
16.1 breaths/minute
STANDARD_DEVIATION 0.52 • n=4 Participants
|
16.2 breaths/minute
STANDARD_DEVIATION 0.70 • n=21 Participants
|
|
Oxygen Saturation at Room Air
|
97.4 %
STANDARD_DEVIATION 1.82 • n=5 Participants
|
97.6 %
STANDARD_DEVIATION 0.55 • n=7 Participants
|
97.8 %
STANDARD_DEVIATION 0.45 • n=5 Participants
|
97.7 %
STANDARD_DEVIATION 1.33 • n=4 Participants
|
97.7 %
STANDARD_DEVIATION 1.18 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.Population: Participants with PK concentration profile to enable AUC calculation.
Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours.
Outcome measures
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=3 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=4 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=3 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
AUC of Bempegaldesleukin [Pharmacokinetic Parameter].
|
153.2 hr*ng/ml
Geometric Coefficient of Variation 62.5
|
997.4 hr*ng/ml
Geometric Coefficient of Variation 249.6
|
2704.7 hr*ng/ml
Geometric Coefficient of Variation 73.8
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.Population: Participants with PK concentration profile to enable Cmax calculation.
Maximum observed serum concentration (Cmax) of bempegaldesleukin.
Outcome measures
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=4 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=4 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Cmax of Bempegaldesleukin [Pharmacokinetic Parameter].
|
5.33 ng/ml
Geometric Coefficient of Variation 135.7
|
12.67 ng/ml
Geometric Coefficient of Variation 350.8
|
65.16 ng/ml
Geometric Coefficient of Variation 104.1
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.Population: Participants with PK concentration profile to enable Tmax calculation.
Time to maximum concentration of bempegaldesleukin. Cmax = maximum concentration. Tmax = time to maximum concentration.
Outcome measures
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=4 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=4 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Tmax of Bempegaldesleukin [Pharmacokinetic Parameter].
|
0.067 hours
Interval 0.033 to 0.417
|
0.383 hours
Interval 0.25 to 0.467
|
0.258 hours
Interval 0.083 to 18.417
|
—
|
PRIMARY outcome
Timeframe: Safety and tolerability were evaluated from baseline up to approximately 30 days.Safety and Tolerability of bempegaldesleukin (starting at dose 0.00075 mg/kg) in combination with SOC was evaluated by incidence of Treatment-Emergent Adverse Events of Any Grade, Grade 3-4, and Grade 5 (Death).
Outcome measures
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
n=15 Participants
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Participants with TEAEs of Any Grade
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Participants with TEAEs of Grade 3-4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Participants with TEAEs of Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: The DLT evaluation period was up to approximately 7 days following the bempegaldesleukin treatment.Dose finding for this study was based on the assessment of DLT of bempegaldesleukin dose levels. Number and percentage of patients with any DLT were summarized by bempegaldesleukin dose level in bempegaldesleukin plus SOC treatment groups \[0.00075 mg/kg, N=5; 0.0015 mg/kg, N=5; and 0.003 mg/kg, N=5\] and placebo plus SOC (N=15). Adverse events related to study drug(s) that were defined as DLTs included the following: * Any Grade ≥ 3 drug-related AE. * Any Grade ≥ 3 drug-related laboratory abnormality that was clinically significant per the Investigator. * Respiratory compromise or other virus-related AE attributed to worsening COVID-19, such as severe hypoxia, cyanosis, or chest pain/pressure. The event was considered a DLT if it was confirmed to be at least possibly related to study drug, met any of the above definitions, and was confirmed to have occurred in a patient treated with bempegaldesleukin.
Outcome measures
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
n=15 Participants
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: ALC was evaluated from baseline up to 7 days (Day 8) following the study drug administration.Population: Analysis population included patients with both baseline and Day 8 ALC measures.
To assess the effect of bempegaldesleukin on the time course and extent of changes in absolute lymphocyte counts (ALC). Data are reported by dose and arm for Day 8 compared to baseline.
Outcome measures
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=2 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
n=13 Participants
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm.
|
5.85 Percent change from baseline
Standard Deviation 21.456
|
46 Percent change from baseline
Standard Deviation NA
According to the statistical analysis plan, if n\<3, then Standard Deviation will not be calculated.
|
65.82 Percent change from baseline
Standard Deviation 60.201
|
-4.54 Percent change from baseline
Standard Deviation 19.663
|
SECONDARY outcome
Timeframe: From baseline, following the administration of study drug approximately up to 30 days.The percentage of patients requiring supplemental oxygen was evaluated as part of disease measurements to assess efficacy. No patient in the study required supplemental oxygen.
Outcome measures
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
n=15 Participants
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Percentage of Patients Who Require Supplemental Oxygen.
|
0 % of participants
|
0 % of participants
|
0 % of participants
|
0 % of participants
|
SECONDARY outcome
Timeframe: From baseline up to 7 days (Day 8) following the study drug administration.Population: Analysis population included patients with both baseline and Day 8 scores.
The WHO Clinical Progression Scale scores and descriptors are as follows: 0- Uninfected; no viral RNA detected; 1- Asymptomatic; viral RNA detected; 2- Symptomatic; independent; 3- Symptomatic; assistance needed; 4- Hospitalized, no oxygen therapy(a); 5- Hospitalized; oxygen by mask or nasal prongs ; 6- Hospitalized; oxygen by non-invasive ventilation or high-flow; 7- Intubation and mechanical ventilation, PaO2/FiO2 ≥ 150 or SpO2/FiO2 ≥ 200; 8- Mechanical ventilation, PaO2/FiO2 \< 150 (SpO2/FiO2 \< 200) or vasopressors; 9- Mechanical ventilation, PaO2/FiO2 \< 150 and vasopressors, dialysis, or ECMO; 10- Death. The data are reported for Day 8 by arm. There were no scores rated 3 and higher per this scale at any timepoint. Abbreviations: ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; PaO2 = partial pressure of arterial oxygen; SpO2 = oxygen saturation (a) If hospitalized for isolation only, record status as for ambulatory patient. Source: WHO 2020.
Outcome measures
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=4 Participants
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=5 Participants
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
n=15 Participants
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
Patients with no change from baseline
|
5 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
|
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
Patients with 1-point improvement
|
0 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
|
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
Patients with 2-point improvement
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
Patients with more than 2-point improvement
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
Patients with 1-point worsening
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
Patients with 2-point worsening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
Patients with more than 2-point worsening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Bempegaldesleukin 0.00075 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bempegaldesleukin 0.0015 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Bempegaldesleukin 0.003 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bempegaldesleukin 0.00075 mg/kg
n=5 participants at risk
Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.0015 mg/kg
n=5 participants at risk
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Bempegaldesleukin 0.003 mg/kg
n=5 participants at risk
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
Placebo
n=15 participants at risk
Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration.
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
|
|---|---|---|---|---|
|
General disorders
Patients with at Least One Treatment-Emergent Adverse Event (TEAE)
|
40.0%
2/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
60.0%
3/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
26.7%
4/15 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
20.0%
3/15 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
40.0%
2/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/15 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/15 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/15 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/15 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
|
General disorders
Pain
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
20.0%
1/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/15 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
0.00%
0/5 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
6.7%
1/15 • Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place