Coronavirus, Covid19
Conditions
Keywords
COVID-19, Coronavirus, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-2, ACTIV2
Brief summary
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.
Detailed description
This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression. The study includes both infused and non-infused agents and is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III testing of new agents within the same trial infrastructure. Version 7 of the protocol provided for blinded phase II evaluation of an investigational agent for superiority to placebo among participants at lower risk of progression to hospitalization or death, regardless of the mode of administration of the agent. Agents that graduate to phase III after initiation of the protocol version will be evaluated in persons at higher risk for progression to hospitalization or death for non-inferiority to an active comparator (monoclonal antibody cocktail of casirivimab plus imdevimab (REGEN-COV, Regeneron). This active comparator has been shown to be effective in this population in preventing hospitalization or death. When two or more agents are being evaluated in the same phase of the study, the trial design includes sharing of the control group (placebo in phase II and active comparator in phase III) for efficient evaluation of each agent. Investigational agents will be approved by the Trial Oversight Committee (TOC) for phase II evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2 therapeutics in pre-clinical testing, and for which there are suitable pharmacokinetics and safety data from phase I testing, or through clinical or research testing for a different indication, and agent availability. Investigational agents will be included in phase III evaluation based on agent entry criteria for phase III as outlined in the protocol (or by TOC approval based on data available outside ACTIV-2).
Interventions
BIOLOGICALbamlanivimab 7000mg
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
BIOLOGICALBRII-196+BRII-198
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.
BIOLOGICALAZD7442 (IV)
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.
BIOLOGICALAZD7442 (IM)
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.
DRUGSNG001
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.
DRUGCamostat
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.
BIOLOGICALBMS-986414 + BMS-986413
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.
BIOLOGICALSAB-185 (3,840 Units/kg)
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
BIOLOGICALSAB-185 (10,240 Units/kg)
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
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.
DRUGPlacebo for Bamlanivimab 7000mg
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
DRUGPlacebo for Bamlanivimab 700mg
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
DRUGPlacebo for BRII-196+BRII-198
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
DRUGPlacebo for SNG001
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.
DRUGPlacebo for Camostat
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.
DRUGPlacebo for SAB-185 (low dose)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
DRUGPlacebo for BMS-986414 + BMS-986413
Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
DRUGPlacebo for AZD7442 (IV)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
DRUGPlacebo for AZD7442 (IM)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
DRUGPlacebo for SAB-185 (high dose)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
BIOLOGICALbamlanivimab 700mg
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Sponsors
Eli Lilly and Company
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Brii Biosciences Limited
AstraZeneca
Sagent Pharmaceuticals
Synairgen Research Ltd.
Bristol-Myers Squibb
SAb Biotherapeutics, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Unblinded data will be provided to the Data and Safety Monitoring Board for interim analyses. Unblinded Day 28 data will also be provided to a small group of people from the company who owns the investigational agent, to assist the company in deciding if the agent should move into phase 3 evaluation; or in choosing a dose of their agent to move into phase 3 evaluation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US must be conducted at a DAIDS-approved laboratory. * Able to begin study treatment no later than 7 days from self-reported onset of COVID-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: * subjective fever or feeling feverish * cough * shortness of breath or difficulty breathing at rest or with activity * sore throat * body pain or muscle pain/aches * fatigue * headache * chills * nasal obstruction or congestion * nasal discharge * loss of taste or smell * nausea or vomiting * diarrhea * temperature \> 38°C (100.4°F) * One or more of the following signs/symptoms within 24 hours of participating in the study: * subjective fever or feeling feverish * cough * shortness of breath or difficulty breathing at rest or with activity * sore throat * body pain or muscle pain/aches * fatigue * headache * chills * nasal obstruction or congestion * nasal discharge * loss of taste or smell * nausea or vomiting * diarrhea * temperature \> 38°C (100.4°F) * Oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. * Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. * Meet the protocol definition of being at higher risk of progression to hospitalization or death (BRII-196/BRII-198). * In Phase III, meeting the protocol definition of being at higher risk of progression to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413) * For participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note: Participants not of reproductive potential are eligible without requiring the use of a contraceptive method (BRII-196/BRII-198. AZD7442 \[IV\], AZD7442 \[IM\], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413). * Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. Participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. Participants should refrain from sperm donation for 24 weeks after investigational agent administration (BRII-196/BRII-198, AZD7442 \[IV\], AZD7442 \[IM\], SAB-185). * Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. Participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. Participants should refrain from sperm donation for 30 days after investigational agent administration (SNG001). * Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. Participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. Participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (Camostat). * If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. This would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods. * If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (AZD7442 \[IV\], AZD7442 \[IM\], SAB-185). * If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (SNG001). * If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (Camostat). * If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (BMS 986414+BMS 986413).
Exclusion criteria
* History of or current hospitalization for COVID-19. * For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen collected \> 240 hours prior to study entry. * Current need for hospitalization or immediate medical attention. * Use of any prohibited medication listed in the protocol and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study. * Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry. * Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases or COVID-19 vaccines). * Known allergy/sensitivity or hypersensitivity to study drug or placebo. * Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study. * Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 \[IV\], AZD7442 \[IM\], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413). * In phase II, meeting the protocol definition of being at higher risk of progression to hospitalization or death (AZD7442 \[IV\], AZD7442 \[IM\], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413). * Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, or other overlying skin conditions or tattoos that would preclude the assessment of injection site reactions, per the discretion of the investigator (AZD7442 \[IM\]). * Inflammatory skin conditions that compromise the safety of subcutaneous (SC) injections, or other overlying skin conditions or tattoos that would preclude the assessment of infection site reactions, per the discretion of the investigator (BMS 986414+BMS 986413). * History of coagulopathy which, in the opinion of the investigator, would preclude IM injection, or use of oral or injectable anticoagulants (protocol provides more information on prohibited medications) (AZD7442 \[IM\]). * Use of or need for chronic supplemental oxygen (SNG001). * Known severe liver disease prior to enrollment (defined as ALT or AST \> 5 times upper limit of normal or end stage liver disease with Child-Pugh Class C or Child-Pugh-Turcotte score ≥ 10) (Camostat). * Known severe kidney disease prior to enrollment (defined as estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m² or on renal-replacement therapy such as peritoneal dialysis or hemodialysis (Camostat) Other investigational drug protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Level of SARS-CoV-2 RNA From NP Swabs (Phase 3) | Day 3 | Measured from staff-collected NP swabs |
| Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | Thru Day 28 | Duration defined as the number of days from start of investigational agent to the first of four consecutive days when all symptoms scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3) |
| COVID-19 Symptom Severity Ranking (Phases 2 and 3) | From Day 0 thru Day 28 | Symptoms scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptoms: 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 alive and never hospitalized through Day 28: Symptom Severity Ranking=subject-specific AUC (area under curve) joining daily total symptom score associated with COVID-19 disease, over time (through Day 28, counting Day 0 as first day), calculated by trapezoidal rule and rescaled for time by dividing by the total number of trapezoids. Subjects who died within Day 28: Assigned severity score 42; Subjects alive but remaining hospitalized at Day 28: Assigned severity score 41; Subjects alive but no longer hospitalized at Day 28: Assigned severity score 40. Calculated Severity Score=scale of 0 to 42. Higher value=worse health condition. |
| Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | Thru Day 28 | Progression of one or more COVID-19-associated symptoms to a worse status than recorded in study diary at study entry, prior to start of investigational product or placebo |
| Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | Thru Day 28 | Defined as the number of days from start of investigational treatment until the first of two consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary. Not analyzed for Bamlanivimab Phase 2 and Phase 3 arms. |
| 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. |
| Oxygen Saturation Level (Phases 2 and 3) | Thru Day 28 | Measured by pulse oximeter and categorized as \<96% versus ≥96%. Analysis not performed for Bamlanivimab arms. |
| AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | Thru Day 14 | Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time. Not analyzed for Bamlanivimab arms. |
| Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | Thru Day 28 | — |
| Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | Thru Week 24 | — |
| Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | Thru Day 28 | Defined as the number of days from start of investigational treatment until the first of four consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary. Not collected for Bamlanivimab Phase 2 and Phase 3 arms. |
| Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | Day 0 thru Week 24 | 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. |
| 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). |
| 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. |
| Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3) | Thru Day 28 | Hospitalizations due to any cause deemed unrelated to COVID-19 are excluded. 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. |
| Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | Thru Day 14 | Measured from staff-collected NP swabs |
Countries
Argentina, Brazil, Canada, Guatemala, Mexico, Philippines, Puerto Rico, South Africa, United States
Participant flow
Pre-assignment details
All participants were considered to be separately enrolled participants for subsequent phases of the study. BRII arms included pooled participants from Phase 2/Phase 3 to complete a Phase 3 analysis.
Participants by arm
| Arm | Count |
|---|---|
| Bamlanivimab 7000 mg (Phase 2) Administered by IV infusion.
bamlanivimab 7000mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention. | 48 |
| Bamlanivimab 7000mg Placebo (Phase 2) Administered by IV infusion
Placebo for Bamlanivimab 7000mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. | 46 |
| Bamlanivimab 700mg (Phase 2) Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention. | 111 |
| Bamlanivimab 700mg Placebo (Phase 2) Administered by IV infusion
Placebo for Bamlanivimab 700mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. | 112 |
| Bamlanivimab 700mg (Phase 3) Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention. | 990 |
| BRII-196+BRII-198 (Pooled Phase 2/3) Administered by IV infusion
BRII-196+BRII-198: 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. | 383 |
| BRII-196+BRII-198 Placebo (Pooled Phase 2/3) Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. | 396 |
| AZD7442 (IV) (Phase 2) Administered by IV infusion
AZD7442 (IV): 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. | 54 |
| AZD7442 (IV) Placebo (Phase 2) Administered by IV infusion.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. | 27 |
| AZD7442 (IM) (Phase 2) Administered by IM injection
AZD7442 (IM): 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. | 103 |
| AZD7442 (IM) Placebo (Phase 2) Administered by IM injection.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. | 50 |
| SNG001 (Phase 2) Administered by inhalation
SNG001: 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. | 110 |
| SNG001 Placebo (Phase 2) Administered by inhalation.
Placebo for SNG001: 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. | 52 |
| Camostat (Phase 2) Administered as oral tablets
Camostat: 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. | 106 |
| Camostat Placebo (Phase 2) Administered as oral tablets.
Placebo for Camostat: 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. | 51 |
| SAB-185 (Low Dose) (Phase 2) Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention. | 106 |
| SAB-185 (Low Dose) Placebo (Phase 2) Administered by IV infusion.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. | 34 |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population Administered by IV infusion.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
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. | 198 |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 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.
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. | 194 |
| SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
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. | 121 |
| Casirivimab and Imdevimab (Phase 3) NON-OMICRON Population Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 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.
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. | 134 |
| SAB-185 (High Dose) (Phase 2) Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention. | 107 |
| SAB-185 (High Dose) Placebo (Phase 2) Administered by IV infusion.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention. | 39 |
| BMS 986414+BMS 986413 (Phase 2) Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: 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. | 105 |
| BMS 986414+BMS 986413 Placebo (Phase 2) Administered as subcutaneous (SC) injections.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention. | 58 |
| Total | 3,735 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 12 | 2 | 11 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 4 | 4 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Dual Enrolled Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Excluded from analysis at NIH request (due to suspected scientific misconduct at site level) | 0 | 0 | 0 | 0 | 81 | 37 | 23 | 4 | 6 | 3 | 4 | 0 | 0 | 4 | 0 | 1 | 1 | 21 | 16 | 21 | 19 | 3 | 2 | 4 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 8 | 5 | 92 | 25 | 25 | 3 | 2 | 13 | 9 | 13 | 9 | 13 | 8 | 10 | 6 | 13 | 21 | 6 | 7 | 21 | 1 | 7 | 6 |
| Overall Study | Other | 1 | 0 | 0 | 1 | 6 | 6 | 5 | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 3 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 2 | 2 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 2 | 17 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 2 | 0 | 3 | 0 |
| Overall Study | Randomized but not treated | 0 | 0 | 0 | 2 | 6 | 4 | 3 | 3 | 0 | 4 | 0 | 0 | 1 | 3 | 3 | 3 | 4 | 5 | 4 | 0 | 0 | 5 | 0 | 3 | 1 |
| Overall Study | Requirement to start alternative therapy | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Screen Fail but Randomized | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 3 | 20 | 20 | 25 | 6 | 1 | 12 | 5 | 7 | 2 | 13 | 4 | 9 | 0 | 15 | 12 | 9 | 14 | 3 | 2 | 9 | 8 |
Baseline characteristics
| Characteristic | BMS 986414+BMS 986413 Placebo (Phase 2) | BMS 986414+BMS 986413 (Phase 2) | SAB-185 (High Dose) Placebo (Phase 2) | SAB-185 (High Dose) (Phase 2) | Casirivimab and Imdevimab (Phase 3) NON-OMICRON Population | SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population | Casirivimab and Imdevimab (Phase 3) OMICRON Population | SAB-185 (Low Dose) (Phase 3) OMICRON Population | SAB-185 (Low Dose) Placebo (Phase 2) | SAB-185 (Low Dose) (Phase 2) | Camostat Placebo (Phase 2) | Camostat (Phase 2) | SNG001 Placebo (Phase 2) | SNG001 (Phase 2) | AZD7442 (IM) Placebo (Phase 2) | AZD7442 (IM) (Phase 2) | AZD7442 (IV) Placebo (Phase 2) | AZD7442 (IV) (Phase 2) | BRII-196+BRII-198 Placebo (Pooled Phase 2/3) | BRII-196+BRII-198 (Pooled Phase 2/3) | Bamlanivimab 700mg (Phase 3) | Bamlanivimab 700mg Placebo (Phase 2) | Bamlanivimab 700mg (Phase 2) | Bamlanivimab 7000mg Placebo (Phase 2) | Bamlanivimab 7000 mg (Phase 2) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 13.02 | 42.8 years STANDARD_DEVIATION 14.57 | 40.6 years STANDARD_DEVIATION 14.88 | 39.9 years STANDARD_DEVIATION 12.47 | 52.7 years STANDARD_DEVIATION 14.16 | 54.9 years STANDARD_DEVIATION 13.12 | 52.8 years STANDARD_DEVIATION 15.86 | 50.1 years STANDARD_DEVIATION 14.23 | 37.3 years STANDARD_DEVIATION 11.22 | 39.0 years STANDARD_DEVIATION 10.94 | 38.5 years STANDARD_DEVIATION 11.57 | 37.7 years STANDARD_DEVIATION 12.72 | 40.1 years STANDARD_DEVIATION 12.05 | 40.2 years STANDARD_DEVIATION 12.37 | 36.8 years STANDARD_DEVIATION 12.07 | 39.9 years STANDARD_DEVIATION 11.8 | 44.6 years STANDARD_DEVIATION 13.63 | 42.5 years STANDARD_DEVIATION 12.06 | 48.7 years STANDARD_DEVIATION 13.68 | 47.8 years STANDARD_DEVIATION 13.59 | 51.1 years STANDARD_DEVIATION 15.92 | 46.7 years STANDARD_DEVIATION 13.69 | 45.2 years STANDARD_DEVIATION 13.52 | 41.5 years STANDARD_DEVIATION 13.79 | 46.1 years STANDARD_DEVIATION 15.8 | 47.2 years STANDARD_DEVIATION 14.99 |
| Age, Customized 55 or older | 10 Participants | 21 Participants | 7 Participants | 15 Participants | 72 Participants | 69 Participants | 89 Participants | 83 Participants | 2 Participants | 6 Participants | 7 Participants | 9 Participants | 8 Participants | 12 Participants | 4 Participants | 11 Participants | 6 Participants | 9 Participants | 140 Participants | 129 Participants | 408 Participants | 31 Participants | 27 Participants | 11 Participants | 18 Participants | 1204 Participants |
| Age, Customized 60 or older | 6 Participants | 15 Participants | 5 Participants | 7 Participants | 41 Participants | 45 Participants | 63 Participants | 52 Participants | 0 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 1 Participants | 4 Participants | 5 Participants | 4 Participants | 93 Participants | 81 Participants | 299 Participants | 19 Participants | 13 Participants | 4 Participants | 11 Participants | 785 Participants |
| Age, Customized Younger than 55 | 48 Participants | 84 Participants | 32 Participants | 92 Participants | 62 Participants | 52 Participants | 105 Participants | 115 Participants | 32 Participants | 100 Participants | 44 Participants | 97 Participants | 44 Participants | 98 Participants | 46 Participants | 92 Participants | 21 Participants | 45 Participants | 256 Participants | 254 Participants | 582 Participants | 81 Participants | 84 Participants | 35 Participants | 30 Participants | 2531 Participants |
| Age, Customized Younger than 60 | 52 Participants | 90 Participants | 34 Participants | 100 Participants | 93 Participants | 76 Participants | 131 Participants | 146 Participants | 34 Participants | 102 Participants | 48 Participants | 103 Participants | 49 Participants | 106 Participants | 49 Participants | 99 Participants | 22 Participants | 50 Participants | 303 Participants | 302 Participants | 691 Participants | 93 Participants | 98 Participants | 42 Participants | 37 Participants | 2950 Participants |
| Baseline BMI (kg/m2 ) | 27.1 kg/m2 STANDARD_DEVIATION 4.63 | 28.0 kg/m2 STANDARD_DEVIATION 5.43 | 29.4 kg/m2 STANDARD_DEVIATION 4.44 | 28.1 kg/m2 STANDARD_DEVIATION 6.13 | 33.7 kg/m2 STANDARD_DEVIATION 7.09 | 31.3 kg/m2 STANDARD_DEVIATION 6.49 | 33.1 kg/m2 STANDARD_DEVIATION 7.59 | 32.9 kg/m2 STANDARD_DEVIATION 7.84 | 27.8 kg/m2 STANDARD_DEVIATION 6.01 | 28.0 kg/m2 STANDARD_DEVIATION 7.37 | 27.4 kg/m2 STANDARD_DEVIATION 4.93 | 28.4 kg/m2 STANDARD_DEVIATION 6.26 | 27.9 kg/m2 STANDARD_DEVIATION 5.2 | 27.9 kg/m2 STANDARD_DEVIATION 6.95 | 28.7 kg/m2 STANDARD_DEVIATION 5.47 | 28.9 kg/m2 STANDARD_DEVIATION 5.94 | 30.3 kg/m2 STANDARD_DEVIATION 7.81 | 32.8 kg/m2 STANDARD_DEVIATION 8.7 | 31.4 kg/m2 STANDARD_DEVIATION 7.25 | 30.7 kg/m2 STANDARD_DEVIATION 7.44 | 29.5 kg/m2 STANDARD_DEVIATION 6.81 | 28.3 kg/m2 STANDARD_DEVIATION 6.28 | 29.7 kg/m2 STANDARD_DEVIATION 6.08 | 29.2 kg/m2 STANDARD_DEVIATION 7.2 | 28.4 kg/m2 STANDARD_DEVIATION 4.62 | 30.1 kg/m2 STANDARD_DEVIATION 7.03 |
| BMI category (kg/m2 ) Greater than 35 kg/m2 | 2 Participants | 9 Participants | 4 Participants | 13 Participants | 61 Participants | 40 Participants | 77 Participants | 82 Participants | 3 Participants | 8 Participants | 1 Participants | 11 Participants | 4 Participants | 9 Participants | 5 Participants | 14 Participants | 7 Participants | 22 Participants | 115 Participants | 99 Participants | 162 Participants | 11 Participants | 18 Participants | 5 Participants | 4 Participants | 786 Participants |
| BMI category (kg/m2 ) Less than or equal to 35 kg/m2 | 56 Participants | 96 Participants | 35 Participants | 92 Participants | 73 Participants | 81 Participants | 117 Participants | 116 Participants | 30 Participants | 95 Participants | 50 Participants | 94 Participants | 48 Participants | 99 Participants | 45 Participants | 89 Participants | 19 Participants | 31 Participants | 279 Participants | 278 Participants | 799 Participants | 86 Participants | 77 Participants | 34 Participants | 38 Participants | 2857 Participants |
| BMI category (kg/m2 ) Participants with missing data | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants | 29 Participants | 15 Participants | 16 Participants | 7 Participants | 6 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 54 Participants | 22 Participants | 44 Participants | 55 Participants | 62 Participants | 100 Participants | 117 Participants | 18 Participants | 45 Participants | 27 Participants | 58 Participants | 27 Participants | 58 Participants | 16 Participants | 49 Participants | 13 Participants | 24 Participants | 191 Participants | 190 Participants | 328 Participants | 31 Participants | 18 Participants | 17 Participants | 15 Participants | 1616 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 51 Participants | 17 Participants | 63 Participants | 79 Participants | 59 Participants | 94 Participants | 81 Participants | 16 Participants | 61 Participants | 24 Participants | 48 Participants | 25 Participants | 52 Participants | 34 Participants | 54 Participants | 14 Participants | 30 Participants | 205 Participants | 193 Participants | 660 Participants | 79 Participants | 93 Participants | 28 Participants | 33 Participants | 2114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 10 Participants | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 32 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 4 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 22 Participants | 15 Participants | 57 Participants | 4 Participants | 2 Participants | 5 Participants | 0 Participants | 134 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 10 Participants | 1 Participants | 15 Participants | 12 Participants | 4 Participants | 16 Participants | 17 Participants | 1 Participants | 9 Participants | 7 Participants | 4 Participants | 3 Participants | 13 Participants | 8 Participants | 8 Participants | 4 Participants | 9 Participants | 62 Participants | 79 Participants | 63 Participants | 10 Participants | 13 Participants | 2 Participants | 3 Participants | 381 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 4 Participants | 7 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 34 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Not collected or reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 10 Participants | 11 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 5 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 15 Participants | 14 Participants | 16 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 100 Participants |
| Race/Ethnicity, Customized White | 49 Participants | 90 Participants | 38 Participants | 86 Participants | 117 Participants | 113 Participants | 154 Participants | 156 Participants | 30 Participants | 89 Participants | 42 Participants | 95 Participants | 40 Participants | 85 Participants | 38 Participants | 85 Participants | 21 Participants | 44 Participants | 293 Participants | 270 Participants | 840 Participants | 92 Participants | 92 Participants | 37 Participants | 41 Participants | 3037 Participants |
| Sex: Female, Male Female | 29 Participants | 57 Participants | 22 Participants | 59 Participants | 67 Participants | 72 Participants | 107 Participants | 108 Participants | 16 Participants | 62 Participants | 26 Participants | 62 Participants | 26 Participants | 66 Participants | 30 Participants | 51 Participants | 16 Participants | 33 Participants | 209 Participants | 197 Participants | 515 Participants | 56 Participants | 54 Participants | 23 Participants | 26 Participants | 1989 Participants |
| Sex: Female, Male Male | 29 Participants | 48 Participants | 17 Participants | 48 Participants | 67 Participants | 49 Participants | 87 Participants | 90 Participants | 18 Participants | 44 Participants | 25 Participants | 44 Participants | 26 Participants | 44 Participants | 20 Participants | 52 Participants | 11 Participants | 21 Participants | 187 Participants | 186 Participants | 475 Participants | 56 Participants | 57 Participants | 23 Participants | 22 Participants | 1746 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 46 | 0 / 111 | 0 / 112 | 12 / 990 | 2 / 383 | 11 / 397 | 0 / 55 | 1 / 51 | 0 / 103 | 1 / 111 | 0 / 110 | 0 / 110 | 1 / 106 | 1 / 105 | 0 / 106 | 0 / 103 | 1 / 198 | 4 / 194 | 4 / 121 | 1 / 134 | 0 / 107 | 0 / 102 | 0 / 105 | 0 / 107 |
| other Total, other adverse events | 26 / 48 | 26 / 46 | 69 / 111 | 57 / 112 | 334 / 990 | 223 / 390 | 228 / 390 | 29 / 55 | 20 / 51 | 40 / 103 | 40 / 111 | 54 / 110 | 57 / 110 | 53 / 106 | 57 / 105 | 52 / 106 | 42 / 103 | 93 / 198 | 91 / 194 | 64 / 121 | 85 / 134 | 59 / 107 | 40 / 102 | 52 / 105 | 48 / 107 |
| serious Total, serious adverse events | 2 / 48 | 6 / 46 | 5 / 111 | 4 / 112 | 57 / 990 | 25 / 390 | 56 / 390 | 0 / 55 | 4 / 51 | 4 / 103 | 7 / 111 | 2 / 110 | 8 / 110 | 9 / 106 | 7 / 105 | 5 / 106 | 5 / 103 | 10 / 198 | 13 / 194 | 11 / 121 | 10 / 134 | 5 / 107 | 5 / 102 | 7 / 105 | 5 / 107 |
Outcome results
Primary
COVID-19 Symptom Duration (Phase 2)
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.
Time frame: Up to Day 28
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 21.0 Days |
| Bamlanivimab 7000mg Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 18.5 Days |
| Bamlanivimab 700mg (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 24.0 Days |
| Bamlanivimab 700mg Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 20.5 Days |
| AZD7442 (IV) (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 11.00 Days |
| AZD7442 (IV) Pooled Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 10.00 Days |
| AZD7442 (IM) (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 8.00 Days |
| AZD7442 (IM) Pooled Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 10.00 Days |
| SNG001 (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 13.0 Days |
| SNG001 Pooled Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 9.0 Days |
| Camostat (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 9 Days |
| Camostat Pooled Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 9 Days |
| SAB-185 (Low Dose) (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 11.0 Days |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 10.0 Days |
| SAB-185 (High Dose) (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 8.0 Days |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 10.0 Days |
| BMS 986414+BMS 986413 (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 8.0 Days |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 2) | 10.0 Days |
Primary
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)
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.
Time frame: Thru Day 28
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | 35 Events |
| Bamlanivimab 7000mg Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | 8 Events |
| Bamlanivimab 700mg (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | 44 Events |
| Bamlanivimab 700mg Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | 5 Events |
| AZD7442 (IV) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | 3 Events |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | 6 Events |
| AZD7442 (IM) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3) | 3 Events |
Primary
Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)
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
Time frame: Thru Day 28
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 6 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 6 Participants |
| Bamlanivimab 700mg (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 12 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 6 Participants |
| AZD7442 (IV) (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 4 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 6 Participants |
| AZD7442 (IM) (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 10 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 8 Participants |
| SNG001 (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 4 Participants |
| SNG001 Pooled Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 9 Participants |
| Camostat (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 10 Participants |
| Camostat Pooled Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 8 Participants |
| SAB-185 (Low Dose) (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 5 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 11 Participants |
| SAB-185 (High Dose) (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 10 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 10 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 6 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2) | 15 Participants |
Primary
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3)
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
Time frame: Thru Day 28
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | 71 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | 30 Participants |
| Bamlanivimab 700mg (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | 67 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | 28 Participants |
| AZD7442 (IV) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | 16 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | 17 Participants |
| AZD7442 (IM) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3) | 20 Participants |
Primary
Quantification of SARS-CoV-2 RNA (Phase 2)
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).
Time frame: Day 7
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 35 Participants |
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 11 Participants |
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 2 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 3 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 33 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 10 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 13 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 7 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 91 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 89 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 17 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 6 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 12 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 8 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 35 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 31 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 13 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 7 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 66 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 20 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 17 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 34 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 59 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 18 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 33 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 17 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 60 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 62 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 32 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 16 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 53 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 31 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 22 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 60 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 16 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 29 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 15 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 28 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 63 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 29 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 54 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 20 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 14 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 24 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 69 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 30 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 52 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 20 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 71 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 19 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 15 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 19 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 64 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 24 Participants |
Primary
Quantification of SARS-CoV-2 RNA (Phase 2)
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.
Time frame: Day 3
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 8 Participants |
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 38 Participants |
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 2 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 8 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 36 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 2 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 6 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 97 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 8 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 100 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 7 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 5 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 25 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 6 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 24 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 21 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 7 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 23 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 26 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 57 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 20 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 52 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 36 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 23 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 67 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 17 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 26 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 57 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 16 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 37 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 28 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 60 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 18 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 32 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 48 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 25 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 23 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 44 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 39 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 34 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 14 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 55 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 56 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 16 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 35 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 14 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 32 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 56 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 17 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 42 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 46 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 49 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 44 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 14 Participants |
Primary
Quantification of SARS-CoV-2 RNA (Phase 2)
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).
Time frame: Day 14
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 24 Participants |
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 2 Participants |
| Bamlanivimab 7000mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 22 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 14 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 28 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 4 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 65 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 35 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 11 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 33 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 10 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 69 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 2 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 44 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 9 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 6 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 42 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 3 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 21 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 70 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 12 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 10 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 20 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 81 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 9 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 85 Participants |
| SNG001 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 16 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 83 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 19 Participants |
| SNG001 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 8 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 22 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 73 Participants |
| Camostat (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 11 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 10 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 20 Participants |
| Camostat Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 75 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 16 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 9 Participants |
| SAB-185 (Low Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 81 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 81 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 17 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 5 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 6 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 16 Participants |
| SAB-185 (High Dose) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 85 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 18 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 78 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 6 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 82 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 15 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 8 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 15 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Detected (greater than or equal to LLOQ) | 7 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 2) | Undetected (less than LLOQ) | 85 Participants |
Secondary
AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2)
Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time. Not analyzed for Bamlanivimab arms.
Time frame: Thru Day 14
Population: 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).~Participants with missing or unsuitable samples were excluded from analysis. All placebo arms except for Bamlanivimab include pooled placebo data. This OM was not a pre-specified outcome for Bamlanivimab Phase 2 and therefore not done.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD7442 (IV) (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 9.2 units on a scale*days | Standard Deviation 10.127 |
| AZD7442 (IV) Pooled Placebo (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 11.7 units on a scale*days | Standard Deviation 16.505 |
| AZD7442 (IM) (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 12.5 units on a scale*days | Standard Deviation 11.497 |
| AZD7442 (IM) Pooled Placebo (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 14.0 units on a scale*days | Standard Deviation 15.134 |
| SNG001 (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 13.7450 units on a scale*days | Standard Deviation 11.0393 |
| SNG001 Pooled Placebo (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 13.1472 units on a scale*days | Standard Deviation 13.34285 |
| Camostat (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 15.2756 units on a scale*days | Standard Deviation 12.81071 |
| Camostat Pooled Placebo (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 13.9833 units on a scale*days | Standard Deviation 13.85182 |
| SAB-185 (Low Dose) (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 11.2405 units on a scale*days | Standard Deviation 12.0687 |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 12.8663 units on a scale*days | Standard Deviation 14.03668 |
| SAB-185 (High Dose) (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 11.6766 units on a scale*days | Standard Deviation 11.40875 |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 13.6064 units on a scale*days | Standard Deviation 14.17869 |
| BMS 986414+BMS 986413 (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 9.5 units on a scale*days | Standard Deviation 11.2 |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2) | 10.9 units on a scale*days | Standard Deviation 11.87 |
Secondary
COVID-19 Symptom Duration (Phase 3)
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.
Time frame: Thru Day 28
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | COVID-19 Symptom Duration (Phase 3) | 21.5 Days |
| Bamlanivimab 7000mg Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 3) | 11.0 Days |
| Bamlanivimab 700mg (Phase 2) | COVID-19 Symptom Duration (Phase 3) | 11.0 Days |
| Bamlanivimab 700mg Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 3) | 11.0 Days |
| AZD7442 (IV) (Phase 2) | COVID-19 Symptom Duration (Phase 3) | 13.00 Days |
| AZD7442 (IV) Pooled Placebo (Phase 2) | COVID-19 Symptom Duration (Phase 3) | 11.0 Days |
| AZD7442 (IM) (Phase 2) | COVID-19 Symptom Duration (Phase 3) | 14.0 Days |
Secondary
COVID-19 Symptom Severity Ranking (Phases 2 and 3)
Symptoms scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptoms: 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 alive and never hospitalized through Day 28: Symptom Severity Ranking=subject-specific AUC (area under curve) joining daily total symptom score associated with COVID-19 disease, over time (through Day 28, counting Day 0 as first day), calculated by trapezoidal rule and rescaled for time by dividing by the total number of trapezoids. Subjects who died within Day 28: Assigned severity score 42; Subjects alive but remaining hospitalized at Day 28: Assigned severity score 41; Subjects alive but no longer hospitalized at Day 28: Assigned severity score 40. Calculated Severity Score=scale of 0 to 42. Higher value=worse health condition.
Time frame: From Day 0 thru Day 28
Population: Analysis population description: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 3.4940 units on a scale*days | Standard Deviation 7.83544 |
| Bamlanivimab 7000mg Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 5.6939 units on a scale*days | Standard Deviation 11.09572 |
| Bamlanivimab 700mg (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.1395 units on a scale*days | Standard Deviation 7.35047 |
| Bamlanivimab 700mg Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.0378 units on a scale*days | Standard Deviation 7.37122 |
| AZD7442 (IV) (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.4001 units on a scale*days | Standard Deviation 7.42311 |
| AZD7442 (IV) Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.1213 units on a scale*days | Standard Deviation 6.12801 |
| AZD7442 (IM) (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 7.8505 units on a scale*days | Standard Deviation 12.16647 |
| AZD7442 (IM) Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 3.5 units on a scale*days | Standard Deviation 3.35 |
| SNG001 (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 5.8 units on a scale*days | Standard Deviation 10.44 |
| SNG001 Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.6 units on a scale*days | Standard Deviation 8.16 |
| Camostat (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 5.5 units on a scale*days | Standard Deviation 9.74 |
| Camostat Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 3.6360 units on a scale*days | Standard Deviation 4.67064 |
| SAB-185 (Low Dose) (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 5.5345 units on a scale*days | Standard Deviation 9.68874 |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 5.3314 units on a scale*days | Standard Deviation 9.41155 |
| SAB-185 (High Dose) (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 5.1306 units on a scale*days | Standard Deviation 8.69588 |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.1020 units on a scale*days | Standard Deviation 6.33252 |
| BMS 986414+BMS 986413 (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.5759 units on a scale*days | Standard Deviation 7.82761 |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.7658 units on a scale*days | Standard Deviation 6.71588 |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 5.0532 units on a scale*days | Standard Deviation 6.03326 |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 5.6263 units on a scale*days | Standard Deviation 8.89389 |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.5862 units on a scale*days | Standard Deviation 6.27948 |
| Camostat (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.6631 units on a scale*days | Standard Deviation 8.38511 |
| Camostat Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.5728 units on a scale*days | Standard Deviation 7.87041 |
| SNG001 (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.6 units on a scale*days | Standard Deviation 7.51 |
| SNG001 Pooled Placebo (Phase 2) | COVID-19 Symptom Severity Ranking (Phases 2 and 3) | 4.2 units on a scale*days | Standard Deviation 6.88 |
Secondary
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
Not applicable to Bamlanivimab arms as these were only 24 week-long studies. 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.
Time frame: Day 0 thru Week 72
Population: Analysis population description: 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 Bamlanivimab arms (Phase 2 \& 3) were only 24 week-long studies, therefore this OM was not a pre-specified outcome and is not applicable.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD7442 (IV) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 23 Events |
| AZD7442 (IM) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 59 Events |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 3 Events |
| SNG001 (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| SNG001 Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 7 Events |
| Camostat (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 8 Events |
| Camostat Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 2 Events |
| SAB-185 (Low Dose) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 7 Events |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 9 Events |
| SAB-185 (High Dose) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 6 Events |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 4 Events |
| BMS 986414+BMS 986413 (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 11 Events |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 9 Events |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| Camostat (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 7 Events |
| Camostat Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| SNG001 (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 10 Events |
| SNG001 Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 13 Events |
Secondary
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
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.
Time frame: Day 0 thru Week 24
Population: Analysis population description: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 2 Events |
| Bamlanivimab 7000mg Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 4 Events |
| Bamlanivimab 700mg (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| Bamlanivimab 700mg Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| AZD7442 (IV) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 44 Events |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 13 Events |
| AZD7442 (IM) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 46 Events |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 1 Events |
| SNG001 (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| SNG001 Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| Camostat (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 8 Events |
| Camostat Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 2 Events |
| SAB-185 (Low Dose) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 7 Events |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 6 Events |
| SAB-185 (High Dose) (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 6 Events |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 3 Events |
| BMS 986414+BMS 986413 (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 7 Events |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 8 Events |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| Camostat (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 7 Events |
| Camostat Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
| SNG001 (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 6 Events |
| SNG001 Pooled Placebo (Phase 2) | Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3) | 5 Events |
Secondary
Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2)
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.
Time frame: Thru Day 28
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 2 Events |
| Bamlanivimab 7000mg Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 4 Events |
| Bamlanivimab 700mg (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 4 Events |
| Bamlanivimab 700mg Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 4 Events |
| AZD7442 (IV) (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 0 Events |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 4 Events |
| AZD7442 (IM) (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 4 Events |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 7 Events |
| SNG001 (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 1 Events |
| SNG001 Pooled Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 7 Events |
| Camostat (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 6 Events |
| Camostat Pooled Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 5 Events |
| SAB-185 (Low Dose) (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 2 Events |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 4 Events |
| SAB-185 (High Dose) (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 5 Events |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 4 Events |
| BMS 986414+BMS 986413 (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 6 Events |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2) | 4 Events |
Secondary
Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3)
Hospitalizations due to any cause deemed unrelated to COVID-19 are excluded. 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.
Time frame: Thru Day 28
Population: 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).~Bamlanivimab 700mg (Phase 3) enrolled under Protocol v1, BRII enrolled under v6 or earlier, this OM was a new addition in v8 so this OM was not pre-specified and therefore not done.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bamlanivimab 700mg Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3) | 4 Events |
| AZD7442 (IV) (Phase 2) | Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3) | 3 Events |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3) | 6 Events |
| AZD7442 (IM) (Phase 2) | Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3) | 2 Events |
Secondary
Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3)
Duration defined as the number of days from start of investigational agent to the first of four consecutive days when all symptoms scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
Time frame: Thru Day 28
Population: Analysis population description: 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).~Bamlanivimab Ph2\&3 enrolled under v1, Camostat, SNG001, SAB Ph2 enrolled under Protocol v6 or earlier, this OM was a new addition in protocol v8 so this OM was not pre-specified and therefore not done.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AZD7442 (IV) Pooled Placebo (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 19.0 Days |
| AZD7442 (IM) (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 23.0 Days |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 16.00 Days |
| SNG001 (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 17.00 Days |
| SNG001 Pooled Placebo (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 16.00 Days |
| Camostat (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 14.00 Days |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 16.0 Days |
| SAB-185 (High Dose) (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 24.0 Days |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 8.0 Days |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 10.0 Days |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | 18.0 Days |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3) | NA Days |
Secondary
Level of SARS-CoV-2 RNA From NP Swabs (Phase 2)
Measured from staff-collected NP swabs
Time frame: Thru Day 14
Population: 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). Participants with missing or unsuitable samples were excluded from analysis.~All placebo arms except for Bamlanivimab include pooled placebo data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.357 log 10 copies/mL | Standard Deviation 0.8371 |
| Bamlanivimab 7000mg Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.201 log 10 copies/mL | Standard Deviation 0.8123 |
| Bamlanivimab 700mg (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.669 log 10 copies/mL | Standard Deviation 1.0883 |
| Bamlanivimab 700mg Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.552 log 10 copies/mL | Standard Deviation 0.7373 |
| AZD7442 (IV) (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.09 log 10 copies/mL | Standard Deviation 0.565 |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.15 log 10 copies/mL | Standard Deviation 0.655 |
| AZD7442 (IM) (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.20 log 10 copies/mL | Standard Deviation 0.857 |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.32 log 10 copies/mL | Standard Deviation 0.74 |
| SNG001 (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.051 log 10 copies/mL | Standard Deviation 0.6425 |
| SNG001 Pooled Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.114 log 10 copies/mL | Standard Deviation 0.6786 |
| Camostat (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.315 log 10 copies/mL | Standard Deviation 0.7722 |
| Camostat Pooled Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.316 log 10 copies/mL | Standard Deviation 0.7152 |
| SAB-185 (Low Dose) (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.095 log 10 copies/mL | Standard Deviation 0.8025 |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 0.953 log 10 copies/mL | Standard Deviation 0.5247 |
| SAB-185 (High Dose) (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 0.950 log 10 copies/mL | Standard Deviation 0.6005 |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 0.976 log 10 copies/mL | Standard Deviation 0.5428 |
| BMS 986414+BMS 986413 (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.1 log 10 copies/mL | — |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 2) | 1.0 log 10 copies/mL | — |
Secondary
Level of SARS-CoV-2 RNA From NP Swabs (Phase 3)
Measured from staff-collected NP swabs
Time frame: Day 3
Population: Bamlanivimab 700mg (Phase 3) enrolled under Protocol v1, this OM was a new addition in v7 so this OM was not pre-specified and therefore not done. Participants with missing records or excluded due to unsuitable sample specimen conditions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bamlanivimab 7000mg Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 3) | 2.899 log 10 copies/mL | Standard Deviation 1.5822 |
| Bamlanivimab 700mg (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 3) | 3.122 log 10 copies/mL | Standard Deviation 2.0459 |
| Bamlanivimab 700mg Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 3) | 3.960 log 10 copies/mL | Standard Deviation 2.1722 |
| AZD7442 (IV) (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 3) | 3.857 log 10 copies/mL | Standard Deviation 2.2445 |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 3) | 2.745 log 10 copies/mL | Standard Deviation 2.1912 |
| AZD7442 (IM) (Phase 2) | Level of SARS-CoV-2 RNA From NP Swabs (Phase 3) | 2.935 log 10 copies/mL | Standard Deviation 2.067 |
Secondary
Oxygen Saturation Level (Phases 2 and 3)
Measured by pulse oximeter and categorized as \<96% versus ≥96%. Analysis not performed for Bamlanivimab arms.
Time frame: Thru Day 28
Population: Analysis population description: 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).~This OM was not a pre-specified outcome for all Bamlanivimab arms (Phase 2 \& 3) and therefore not done.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AZD7442 (IV) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 12 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 94 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 6 Participants |
| AZD7442 (IM) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 7 Participants |
| AZD7442 (IM) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 7 Participants |
| AZD7442 (IM) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 94 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 0 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 10 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 45 Participants |
| SNG001 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 7 Participants |
| SNG001 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 42 Participants |
| SNG001 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 2 Participants |
| SNG001 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 2 Participants |
| SNG001 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 89 Participants |
| SNG001 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 12 Participants |
| Camostat (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 18 Participants |
| Camostat (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 90 Participants |
| Camostat (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 3 Participants |
| Camostat Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 10 Participants |
| Camostat Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 99 Participants |
| Camostat Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 1 Participants |
| SAB-185 (Low Dose) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 2 Participants |
| SAB-185 (Low Dose) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 95 Participants |
| SAB-185 (Low Dose) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 13 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 16 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 3 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 87 Participants |
| SAB-185 (High Dose) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 13 Participants |
| SAB-185 (High Dose) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 4 Participants |
| SAB-185 (High Dose) (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 87 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 3 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 95 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 6 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 2 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 11 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 90 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 9 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 15 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 97 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 8 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 111 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 15 Participants |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 9 Participants |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 96 Participants |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 2 Participants |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 2 Participants |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 11 Participants |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 89 Participants |
| Camostat (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 16 Participants |
| Camostat (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 88 Participants |
| Camostat (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 1 Participants |
| Camostat Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 88 Participants |
| Camostat Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 2 Participants |
| Camostat Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 17 Participants |
| SNG001 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 177 Participants |
| SNG001 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 16 Participants |
| SNG001 (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 5 Participants |
| SNG001 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Missing pulse oximetry records | 13 Participants |
| SNG001 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation <96% | 7 Participants |
| SNG001 Pooled Placebo (Phase 2) | Oxygen Saturation Level (Phases 2 and 3) | Oxygen Saturation ≥96% | 171 Participants |
Secondary
Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3)
Progression of one or more COVID-19-associated symptoms to a worse status than recorded in study diary at study entry, prior to start of investigational product or placebo
Time frame: Thru Day 28
Population: Analysis population description: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 42 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 40 Participants |
| Bamlanivimab 700mg (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 102 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 105 Participants |
| AZD7442 (IV) (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 876 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 323 Participants |
| AZD7442 (IM) (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 321 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 42 Participants |
| SNG001 (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 43 Participants |
| SNG001 Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 87 Participants |
| Camostat (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 96 Participants |
| Camostat Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 86 Participants |
| SAB-185 (Low Dose) (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 92 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 82 Participants |
| SAB-185 (High Dose) (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 92 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 81 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 81 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 102 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 119 Participants |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 83 Participants |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 79 Participants |
| Camostat (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 70 Participants |
| Camostat Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 86 Participants |
| SNG001 (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 160 Participants |
| SNG001 Pooled Placebo (Phase 2) | Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3) | 157 Participants |
Secondary
Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
Time frame: Thru Day 28
Population: Analysis population description: 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).~Bamlanivimab Phase 3 enrolled under Protocol v1, this OM was a new addition in v7 for Phase 3 so this OM was not pre-specified and therefore not done.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 19 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 16 Participants |
| Bamlanivimab 700mg (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 47 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 30 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 29 Participants |
| AZD7442 (IM) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 45 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 20 Participants |
| SNG001 (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 14 Participants |
| SNG001 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 30 Participants |
| Camostat (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 25 Participants |
| Camostat Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 24 Participants |
| SAB-185 (Low Dose) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 31 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 29 Participants |
| SAB-185 (High Dose) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 25 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 20 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 26 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 40 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 45 Participants |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 25 Participants |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 23 Participants |
| Camostat (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 22 Participants |
| Camostat Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 28 Participants |
| SNG001 (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 58 Participants |
| SNG001 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 60 Participants |
Secondary
Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
Time frame: Thru Week 24
Population: Analysis population description: 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).~Bamlanivimab 700mg (Phase 3) enrolled under Protocol v1, this OM was a new addition in v7 for Phase 3 so this OM was not pre-specified and therefore not done.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bamlanivimab 7000mg (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 22 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 18 Participants |
| Bamlanivimab 700mg (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 53 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 39 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 45 Participants |
| AZD7442 (IM) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 50 Participants |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 23 Participants |
| SNG001 (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 17 Participants |
| SNG001 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 38 Participants |
| Camostat (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 33 Participants |
| Camostat Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 34 Participants |
| SAB-185 (Low Dose) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 41 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 32 Participants |
| SAB-185 (High Dose) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 32 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 27 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 32 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 46 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 60 Participants |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 31 Participants |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 30 Participants |
| Camostat (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 76 Participants |
| Camostat Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 74 Participants |
| SNG001 (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 72 Participants |
| SNG001 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3) | 69 Participants |
Secondary
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3)
Time frame: Thru Week 24
Population: Analysis population description: 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).~Bamlanivimab Ph2 enrolled under Protocol v1, AZD7442, BMS enrolled under v6, this OM was a new addition for Phase 2 agents in v7 so this OM was not pre-specified and therefore not done.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AZD7442 (IV) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 92 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 37 Participants |
| AZD7442 (IM) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 74 Participants |
| Camostat Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 5 Participants |
| SAB-185 (Low Dose) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 11 Participants |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 12 Participants |
| SAB-185 (High Dose) (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 12 Participants |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 8 Participants |
| BMS 986414+BMS 986413 (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 13 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 17 Participants |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 27 Participants |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 11 Participants |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 12 Participants |
| SNG001 (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 30 Participants |
| SNG001 Pooled Placebo (Phase 2) | Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3) | 18 Participants |
Secondary
Quantification of SARS-CoV-2 RNA (Phase 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).
Time frame: Day 3
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Undetected (less than LLOQ) | 37 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Detected (greater than or equal to LLOQ) | 63 Participants |
| Bamlanivimab 7000mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 12 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Detected (greater than or equal to LLOQ) | 58 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 16 Participants |
| Bamlanivimab 700mg (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Undetected (less than LLOQ) | 35 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Detected (greater than or equal to LLOQ) | 119 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 32 Participants |
| Bamlanivimab 700mg Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Undetected (less than LLOQ) | 47 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 36 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Undetected (less than LLOQ) | 47 Participants |
| AZD7442 (IV) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Detected (greater than or equal to LLOQ) | 111 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 8 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Detected (greater than or equal to LLOQ) | 56 Participants |
| AZD7442 (IV) Pooled Placebo (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Undetected (less than LLOQ) | 57 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Participants with missing records or excluded due to unsuitable sample specimen conditions | 14 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Detected (greater than or equal to LLOQ) | 69 Participants |
| AZD7442 (IM) (Phase 2) | Quantification of SARS-CoV-2 RNA (Phase 3) | Undetected (less than LLOQ) | 51 Participants |
Secondary
Time to Self-reported Return to Usual Health (a) (Phases 2 and 3)
Defined as the number of days from start of investigational treatment until the first of two consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary. Not analyzed for Bamlanivimab Phase 2 and Phase 3 arms.
Time frame: Thru Day 28
Population: Analysis population description: 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).~This OM was not a pre-specified outcome for all Bamlanivimab arms (Phase 2 \& 3) and therefore not done.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AZD7442 (IV) Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 16.0 Days |
| AZD7442 (IM) (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 22.0 Days |
| AZD7442 (IM) Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 11.00 Days |
| SNG001 (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 15.00 Days |
| SNG001 Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 14.00 Days |
| Camostat (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 13.00 Days |
| Camostat Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 19.0 Days |
| SAB-185 (Low Dose) (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 17.0 Days |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 12.0 Days |
| SAB-185 (High Dose) (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 14.0 Days |
| SAB-185 (High Dose) Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 15.0 Days |
| BMS 986414+BMS 986413 (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 17.0 Days |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 11.0 Days |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 12.0 Days |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 12.0 Days |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 17.0 Days |
| Camostat (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 12.0 Days |
| Camostat Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 17.0 Days |
| SNG001 (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 15.0 Days |
| SNG001 Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (a) (Phases 2 and 3) | 13.0 Days |
Secondary
Time to Self-reported Return to Usual Health (b) (Phases 2 and 3)
Defined as the number of days from start of investigational treatment until the first of four consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary. Not collected for Bamlanivimab Phase 2 and Phase 3 arms.
Time frame: Thru Day 28
Population: Analysis population description: Number of subjects in analysis = participants who returned to usual (pre-COVID-19) health.~Bamlanivimab Phase 2\&3 enrolled under v1, Camostat, SNG001, BRII, SAB Ph2 enrolled under Protocol v6 or earlier, OM was new addition in Protocol v8, not pre-specified and therefore not done.~BRII-196+BRII-198 Placebo includes pooled placebo data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AZD7442 (IM) Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 13.00 Days |
| SNG001 (Phase 2) | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 17.00 Days |
| SNG001 Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 15.00 Days |
| Camostat (Phase 2) | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 15.00 Days |
| SAB-185 (Low Dose) Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 14.0 Days |
| SAB-185 (High Dose) (Phase 2) | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 15.0 Days |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 13.0 Days |
| BMS 986414+BMS 986413 Pooled Placebo (Phase 2) | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 17.0 Days |
| SAB-185 (Low Dose) (Phase 3) OMICRON Population | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 17.0 Days |
| Casirivimab and Imdevimab (Phase 3) OMICRON Population | Time to Self-reported Return to Usual Health (b) (Phases 2 and 3) | 15.0 Days |