Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04518410 | ACTIV-2: A Study for Outpatients With COVID-19 | PHASE2 | COMPLETED | 4,044 | — | — | Aug 19, 2020 | Jun 20, 2023 | Aug 2, 2024 | 252 | United States, Argentina +7 |
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.
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.
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
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.
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
| Arm | Type | Description |
|---|---|---|
| Bamlanivimab 7000 mg (Phase 2) | EXPERIMENTAL | Administered by IV infusion. |
| Bamlanivimab 7000mg Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered by IV infusion |
| Bamlanivimab 700mg (Phase 2) | EXPERIMENTAL | Administered by IV infusion |
| Bamlanivimab 700mg Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered by IV infusion |
| Bamlanivimab 700mg (Phase 3) | EXPERIMENTAL | Administered by IV infusion |
| BRII-196+BRII-198 (Pooled Phase 2/3) | EXPERIMENTAL | Administered by IV infusion |
| BRII-196+BRII-198 Placebo (Pooled Phase 2/3) | PLACEBO_COMPARATOR | Administered by IV infusion |
| AZD7442 (IV) (Phase 2) | EXPERIMENTAL | Administered by IV infusion |
| AZD7442 (IV) Pooled Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study. |
| AZD7442 (IM) (Phase 2) | EXPERIMENTAL | Administered by IM injection |
| AZD7442 (IM) Pooled Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study. |
| SNG001 (Phase 2) | EXPERIMENTAL | Administered by inhalation |
| SNG001 Pooled Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered by inhalation; shared placebo includes placebo from other comparator arms in the study. |
| Camostat (Phase 2) | EXPERIMENTAL | Administered as oral tablets |
| Camostat Pooled Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study. |
| SAB-185 (low dose) (Phase 2) | EXPERIMENTAL | Administered by IV infusion |
| SAB-185 (low dose) Pooled Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered by IV infusion; includes SAB-185 (high dose) placebo and placebo from other comparator arms in the study. |
| SAB-185 (low dose) (Phase 3) Non-OMICRON population | EXPERIMENTAL | Administered by IV infusion. The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation." Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows: * Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. * For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation. |
| Casirivimab and Imdevimab (Phase 3) Non-OMICRON population | ACTIVE_COMPARATOR | Administered by IV infusion. The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation." Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows: * Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. * For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation. |
| SAB-185 (high dose) (Phase 2) | EXPERIMENTAL | Administered by IV infusion |
| SAB-185 (high dose) Pooled Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered by IV infusion; includes SAB-185 (low dose) placebo and placebo from other comparator arms in the study. |
| BMS 986414+BMS 986413 (Phase 2) | EXPERIMENTAL | Administered as subcutaneous (SC) injections |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | PLACEBO_COMPARATOR | Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study. |
| SAB-185 (low dose) (Phase 3) OMICRON population | EXPERIMENTAL | Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0. Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows: * Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. * For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation. |
| Casirivimab and Imdevimab (Phase 3) OMICRON population | ACTIVE_COMPARATOR | Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0. Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows: * Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. * For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation. |
| Name | Type | Description |
|---|---|---|
| bamlanivimab 7000mg | BIOLOGICAL | Administered by single IV infusion. Participants are no longer being randomized to this intervention. |
| BRII-196+BRII-198 | BIOLOGICAL | 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention. |
| AZD7442 (IV) | BIOLOGICAL | 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention. |
| AZD7442 (IM) | BIOLOGICAL | Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention. |
| SNG001 | DRUG | 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention. |
| Camostat | DRUG | 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention. |
| BMS-986414 + BMS-986413 | BIOLOGICAL | Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention. |
| SAB-185 (3,840 Units/kg) | BIOLOGICAL | Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention. |
| SAB-185 (10,240 Units/kg) | BIOLOGICAL | Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention. |
| CASIRIVIMAB + IMDEVIMAB | DRUG | 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention. |
| Placebo for Bamlanivimab 7000mg | DRUG | Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. |
| Placebo for Bamlanivimab 700mg | DRUG | Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. |
| Placebo for BRII-196+BRII-198 | DRUG | Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. |
| Placebo for SNG001 | DRUG | Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention. |
| Placebo for Camostat | DRUG | 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention. |
| Placebo for SAB-185 (low dose) | DRUG | Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. |
| Placebo for BMS-986414 + BMS-986413 | DRUG | Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention. |
| Placebo for AZD7442 (IV) | DRUG | Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. |
| Placebo for AZD7442 (IM) | DRUG | Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. |
| Placebo for SAB-185 (high dose) | DRUG | Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. |
| bamlanivimab 700mg | BIOLOGICAL | Administered by single IV infusion. Participants are no longer being randomized to this intervention. |
Inclusion Criteria: * Signed informed consent. * Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10 d...