Trial · NCT04518410
ACTIV-2: A Study for Outpatients With COVID-19
NCT04518410, Phase 2, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2023-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ACTIV-2: A Study for Outpatients With COVID-19. Trials, record NCT04518410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04518410
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ACTIV-2: A Study for Outpatients With COVID-19
- NCT number
- NCT04518410
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 4,044 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Coronavirus, Covid19
- Interventions
bamlanivimab 7000mg, BRII-196+BRII-198, AZD7442 (IV), AZD7442 (IM), SNG001, Camostat, BMS-986414 + BMS-986413, SAB-185 (3,840 Units/kg), SAB-185 (10,240 Units/kg), CASIRIVIMAB + IMDEVIMAB, Placebo for Bamlanivimab 7000mg, Placebo for Bamlanivimab 700mg, Placebo for BRII-196+BRII-198, Placebo for SNG001, Placebo for Camostat, Placebo for SAB-185 (low dose), Placebo for BMS-986414 + BMS-986413, Placebo for AZD7442 (IV), Placebo for AZD7442 (IM), Placebo for SAB-185 (high dose), bamlanivimab 700mg
- First posted
- 2020-08-19
- Last updated
- 2024-08-02
- Results first posted
- 2023-07-27
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | COVID-19 Symptom Duration (Phase 2) | Up to Day 28 | Bamlanivimab arms: Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days. No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition. Non-Bamlanivimab arms: 13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent. No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition. |
| Primary | Quantification of SARS-CoV-2 RNA (Phase 2) | Day 3 | Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml). SNG001 and SNG001 Pooled Placebo arm each exclude 6 participants, due to unsuitable sample specimen conditions. |
| Primary | Quantification of SARS-CoV-2 RNA (Phase 2) | Day 7 | Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml). |
| Primary | Quantification of SARS-CoV-2 RNA (Phase 2) | Day 14 | Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml). |
| Primary | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | Thru Day 28 | AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at: https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables. * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death |
| Primary | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | Thru Day 28 | Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events. |
| Primary | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | Thru Day 28 | AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at: https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables. * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death |
| Secondary | COVID-19 Symptom Duration (Phase 3) | Thru Day 28 | Bamlanivimab arm: Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days. No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition. Non-Bamlanivimab arms: 13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent. No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition. |
| Secondary | Quantification of SARS-CoV-2 RNA (Phase 3) | Day 3 | Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml). |
| Secondary | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | Thru Day 28 | Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | COVID-19 Symptom Duration (Phase 2) | Up to Day 28 | mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~All placebo arms except for Bamlanivimab include pooled placebo data. | Days | MEDIAN |
| PRIMARY | Quantification of SARS-CoV-2 RNA (Phase 2) | Day 3 | mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~All placebo arms except for Bamlanivimab include pooled placebo data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Quantification of SARS-CoV-2 RNA (Phase 2) | Day 7 | mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~All placebo arms except for Bamlanivimab include pooled placebo data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Quantification of SARS-CoV-2 RNA (Phase 2) | Day 14 | mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~All placebo arms except for Bamlanivimab include pooled placebo data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | Thru Day 28 | mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~All placebo arms except for Bamlanivimab include pooled placebo data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | Thru Day 28 | mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~BRII-196+BRII-198 Placebo includes pooled placebo data. | Events | NUMBER |
| PRIMARY | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | Thru Day 28 | mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~BRII-196+BRII-198 Placebo includes pooled placebo data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | COVID-19 Symptom Duration (Phase 3) | Thru Day 28 | Analysis population description (Phase 3): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~BRII-196+BRII-198 Placebo includes pooled placebo data. | Days | MEDIAN |
| SECONDARY | Quantification of SARS-CoV-2 RNA (Phase 3) | Day 3 | Analysis population description (Phase 3): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All placebo arms = pooled placebo data. BRII-196+BRII-198 data is Ph2 subjects only. Bamlanivimab 700mg (Ph3) enrolled under Prot. v1, OM new in v8 so OM not pre-specified, not done. Participants missing records or unsuitable sample specimen conditions excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | Thru Day 28 | Analysis population description (Phase 2): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject).~All placebo arms except for Bamlanivimab include pooled placebo data. | Events | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group557
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| COVID-19 Symptom Duration (Phase 2) | Bamlanivimab 7000mg (Phase 2) | 21.0 | 95% Confidence Interval NA to NA | Days | |
| COVID-19 Symptom Duration (Phase 2) | Bamlanivimab 7000mg Placebo (Phase 2) | 18.5 | 95% Confidence Interval NA to NA | Days | |
| COVID-19 Symptom Duration (Phase 2) | Bamlanivimab 700mg (Phase 2) | 24.0 | 95% Confidence Interval NA to NA | Days | |
| COVID-19 Symptom Duration (Phase 2) | Bamlanivimab 700mg Placebo (Phase 2) | 20.5 | 95% Confidence Interval NA to NA | Days | |
| COVID-19 Symptom Duration (Phase 2) | AZD7442 (IV) (Phase 2) | 11.00 | 95% Confidence Interval 9.00 to 15.00 | Days | |
| COVID-19 Symptom Duration (Phase 2) | AZD7442 (IV) Pooled Placebo (Phase 2) | 10.00 | 95% Confidence Interval 7.00 to 15.00 | Days | |
| COVID-19 Symptom Duration (Phase 2) | AZD7442 (IM) (Phase 2) | 8.00 | 95% Confidence Interval 7.00 to 12.00 | Days | |
| COVID-19 Symptom Duration (Phase 2) | AZD7442 (IM) Pooled Placebo (Phase 2) | 10.00 | 95% Confidence Interval 8.00 to 13.00 | Days | |
| COVID-19 Symptom Duration (Phase 2) | SNG001 (Phase 2) | 13.0 | 95% Confidence Interval 10.0 to 16.0 | Days | |
| COVID-19 Symptom Duration (Phase 2) | SNG001 Pooled Placebo (Phase 2) | 9.0 | 95% Confidence Interval 8.0 to 12.0 | Days |
1 to 10 of 557Source ClinicalTrials.gov
See all 557 results by groupParticipant flow75
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bamlanivimab 7000 mg (Phase 2) | 48 | |
| Overall Study | STARTED | Bamlanivimab 7000mg Placebo (Phase 2) | 46 | |
| Overall Study | STARTED | Bamlanivimab 700mg (Phase 2) | 111 | |
| Overall Study | STARTED | Bamlanivimab 700mg Placebo (Phase 2) | 114 | |
| Overall Study | STARTED | Bamlanivimab 700mg (Phase 3) | 1,079 | |
| Overall Study | STARTED | BRII-196+BRII-198 (Pooled Phase 2/3) | 424 | |
| Overall Study | STARTED | BRII-196+BRII-198 Placebo (Pooled Phase 2/3) | 422 | |
| Overall Study | STARTED | AZD7442 (IV) (Phase 2) | 61 | |
| Overall Study | STARTED | AZD7442 (IV) Placebo (Phase 2) | 33 | |
| Overall Study | STARTED | AZD7442 (IM) (Phase 2) | 110 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 participant flowAdverse events27,275
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Bamlanivimab 7000 mg (Phase 2) | 0 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | Bamlanivimab 7000mg Placebo (Phase 2) | 1 | 46 | |
| other | Anaemia | Blood and lymphatic system disorders | Bamlanivimab 700mg (Phase 2) | 1 | 111 | |
| other | Anaemia | Blood and lymphatic system disorders | Bamlanivimab 700mg Placebo (Phase 2) | 0 | 112 | |
| other | Anaemia | Blood and lymphatic system disorders | Bamlanivimab 700mg (Phase 3) | 1 | 990 | |
| other | Anaemia | Blood and lymphatic system disorders | BRII-196+BRII-198 (Pooled Phase 2/3) | 2 | 390 | |
| other | Anaemia | Blood and lymphatic system disorders | BRII-196+BRII-198 Placebo (Pooled Phase 2/3) | 2 | 390 | |
| other | Anaemia | Blood and lymphatic system disorders | AZD7442 (IV) (Phase 2) | 1 | 55 | |
| other | Anaemia | Blood and lymphatic system disorders | AZD7442 (IV) Pooled Placebo (Phase 2) | 0 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | AZD7442 (IM) (Phase 2) | 1 | 103 |
1 to 10 of 27,275Source ClinicalTrials.gov
See all 27,275 adverse eventsAdverse event totals75
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bamlanivimab 7000 mg (Phase 2) | 0 | 48 |
| Total, all-cause mortality | Bamlanivimab 7000mg Placebo (Phase 2) | 0 | 46 |
| Total, all-cause mortality | Bamlanivimab 700mg (Phase 2) | 0 | 111 |
| Total, all-cause mortality | Bamlanivimab 700mg Placebo (Phase 2) | 0 | 112 |
| Total, all-cause mortality | Bamlanivimab 700mg (Phase 3) | 12 | 990 |
| Total, all-cause mortality | BRII-196+BRII-198 (Pooled Phase 2/3) | 2 | 383 |
| Total, all-cause mortality | BRII-196+BRII-198 Placebo (Pooled Phase 2/3) | 11 | 397 |
| Total, all-cause mortality | AZD7442 (IV) (Phase 2) | 0 | 55 |
| Total, all-cause mortality | AZD7442 (IV) Pooled Placebo (Phase 2) | 1 | 51 |
| Total, all-cause mortality | AZD7442 (IM) (Phase 2) | 0 | 103 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse event totalsPapers28
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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