Trial Outcomes & Findings for ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (NCT NCT04843761)
NCT ID: NCT04843761
Last Updated: 2025-10-24
Results Overview
The primary analysis for each agent was to pool across applicable groups to compare each agent vs. matched placebo. Refer to the agent-specific records for results by agent (H1 \[Aviptadil\]: NCT06729606; H2 \[Remdesivir\]: NCT06729593).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
473 participants
Primary outcome timeframe
Screening, within 24 hours
Results posted on
2025-10-24
Participant Flow
Eligibility for each agent was assessed at the same time. If eligible for both, participants were randomized to a 2x2 factorial design of Aviptadil vs. Aviptadil placebo and Remdesivir vs. Remdesivir placebo with 1:1:1:1 allocation to each of the 4 possible combinations. If eligible for only 1, randomization was 1:1 to that agent or its matched placebo (Appendix H2). The primary analysis for each agent was to pool across applicable groups to compare each agent vs. matched placebo.
The study includes randomization according to 4 strata: * Stratum 1 eligible for both Aviptadil and Remdesivir (no prior Remdesivir) * Stratum 2 eligible for Aviptadil only (Remdesivir contraindicated) * Stratum 3 eligible for Remdesivir only (Aviptadil contraindicated) * Stratum 4 eligible for Aviptadil and have received prior Remdesivir This record presents enrollment data across the full study. Refer to the agent-specific records for results by agent (H1: NCT06729606; H2: NCT06729593)
Participant milestones
| Measure |
Stratum 1 - Aviptadil + Remdesivir
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil +Remdesivir Placebo
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil Placebo + Remdesivir
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil Placebo + Remdesivir Placebo
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 2 - Aviptadil
Eligible for Aviptadil and Remdesivir contraindicated
* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 2 - Aviptadil Placebo
Eligible for Aviptadil and Remdesivir contraindicated
* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 3 - Remdesivir
Eligible for Remdesivir and Aviptadil contraindicated
* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection
* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)
|
Stratum 3 - Remdesivir Placebo
Eligible for Remdesivir and Aviptadil contraindicated
* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection
* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)
|
Stratum 4 - Aviptadil
Eligible for Aviptadil and prior/current use of Remdesivir
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 4 - Aviptadil Placebo
Eligible for Aviptadil and prior/current use of Remdesivir
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
21
|
25
|
21
|
12
|
11
|
1
|
1
|
183
|
180
|
|
Overall Study
COMPLETED
|
18
|
21
|
25
|
21
|
12
|
11
|
1
|
1
|
183
|
180
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
Baseline characteristics by cohort
| Measure |
Stratum 1 - Aviptadil + Remdesivir
n=18 Participants
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil +Remdesivir Placebo
n=21 Participants
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil Placebo + Remdesivir
n=25 Participants
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil Placebo + Remdesivir Placebo
n=21 Participants
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 2 - Aviptadil
n=12 Participants
Eligible for Aviptadil and Remdesivir contraindicated
* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 2 - Aviptadil Placebo
n=11 Participants
Eligible for Aviptadil and Remdesivir contraindicated
* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 3 - Remdesivir
n=1 Participants
Eligible for Remdesivir and Aviptadil contraindicated
* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection
* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)
|
Stratum 3 - Remdesivir Placebo
n=1 Participants
Eligible for Remdesivir and Aviptadil contraindicated
* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection
* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)
|
Stratum 4 - Aviptadil
n=183 Participants
Eligible for Aviptadil and prior/current use of Remdesivir
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 4 - Aviptadil Placebo
n=180 Participants
Eligible for Aviptadil and prior/current use of Remdesivir
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 13 • n=5 Participants
|
55 years
STANDARD_DEVIATION 14 • n=7 Participants
|
56 years
STANDARD_DEVIATION 15 • n=5 Participants
|
56 years
STANDARD_DEVIATION 11 • n=4 Participants
|
60 years
STANDARD_DEVIATION 20 • n=21 Participants
|
54 years
STANDARD_DEVIATION 21 • n=10 Participants
|
71 years
STANDARD_DEVIATION 0 • n=115 Participants
|
70 years
STANDARD_DEVIATION 0 • n=24 Participants
|
57 years
STANDARD_DEVIATION 15 • n=42 Participants
|
57 years
STANDARD_DEVIATION 15 • n=42 Participants
|
57 years
STANDARD_DEVIATION 15 • n=42 Participants
|
|
Age, Customized
<= 18 years
|
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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
123 Participants
n=42 Participants
|
126 Participants
n=42 Participants
|
322 Participants
n=42 Participants
|
|
Age, Customized
>= 65 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
60 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
151 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
74 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
185 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
109 Participants
n=42 Participants
|
109 Participants
n=42 Participants
|
288 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
46 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
122 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
137 Participants
n=42 Participants
|
140 Participants
n=42 Participants
|
351 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
73 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
101 Participants
n=42 Participants
|
107 Participants
n=42 Participants
|
266 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Only ethnicity (race unknown)
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
76 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Screening, within 24 hoursThe primary analysis for each agent was to pool across applicable groups to compare each agent vs. matched placebo. Refer to the agent-specific records for results by agent (H1 \[Aviptadil\]: NCT06729606; H2 \[Remdesivir\]: NCT06729593).
Outcome measures
| Measure |
Stratum 1 - Aviptadil + Remdesivir
n=18 Participants
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil +Remdesivir Placebo
n=21 Participants
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil Placebo + Remdesivir
n=25 Participants
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 1 - Aviptadil Placebo + Remdesivir Placebo
n=21 Participants
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir
* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
|
Stratum 2 - Aviptadil
n=12 Participants
Eligible for Aviptadil and Remdesivir contraindicated
* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 2 - Aviptadil Placebo
n=11 Participants
Eligible for Aviptadil and Remdesivir contraindicated
* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 3 - Remdesivir
n=1 Participants
Eligible for Remdesivir and Aviptadil contraindicated
* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection
* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)
|
Stratum 3 - Remdesivir Placebo
n=1 Participants
Eligible for Remdesivir and Aviptadil contraindicated
* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection
* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)
|
Stratum 4 - Aviptadil
n=183 Participants
Eligible for Aviptadil and prior/current use of Remdesivir
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
Stratum 4 - Aviptadil Placebo
n=180 Participants
Eligible for Aviptadil and prior/current use of Remdesivir
* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy Analysis Cohorts
Aviptadil substudy analysis cohort
|
18 Participants
|
21 Participants
|
25 Participants
|
21 Participants
|
12 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
183 Participants
|
180 Participants
|
|
Substudy Analysis Cohorts
Remdesivir substudy analysis cohort
|
18 Participants
|
21 Participants
|
25 Participants
|
21 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Stratum 1 - Aviptadil + Remdesivir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 1 - Aviptadil +Remdesivir Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 1 - Aviptadil Placebo + Remdesivir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 1 - Aviptadil Placebo + Remdesivir Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 2 - Aviptadil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 2 - Aviptadil Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 3 - Remdesivir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 3 - Remdesivir Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 4 - Aviptadil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 4 - Aviptadil Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place