ACTIV-2: A Study for Outpatients With COVID-19

Inclusion Criteria:

• Signed informed consent.

• Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by amolecular (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 outsidethe US must be conducted at a DAIDS-approved laboratory.

• Able to begin study treatment no later than 7 days from self-reported onset ofCOVID-19 related symptom(s) or measured fever, where the first day of symptoms isconsidered symptom day 0 and defined by the self-reported date of first reportedsign/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 thestudy:

• 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 studystaff within 24 hours of study entry. For a potential participant who regularlyreceives chronic supplementary oxygen for an underlying lung condition, their oxygensaturation should be measured while on their standard home oxygen supplementationlevel.

• Participant must agree not to participate in another clinical trial for thetreatment 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 tohospitalization or death (BRII-196/BRII-198).

• In Phase III, meeting the protocol definition of being at "higher" risk ofprogression to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)

• For participants of reproductive potential, negative serum or urine pregnancy testwithin 48 hours prior to study entry by any clinic or laboratory that has a CLIAcertification 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 ofa 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 theirpartner must agree to either remain abstinent or use male contraceptives. They arestrongly advised to inform their non-pregnant sexual partners of reproductivepotential to use effective contraceptives for 24 weeks after investigational productis administered. Participants with pregnant partners should use condoms duringvaginal intercourse through 24 weeks after investigational agent administration.Participants should refrain from sperm donation for 24 weeks after investigationalagent administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).

• Participants that engage in sexual activity that may lead to pregnancy in theirpartner must agree to either remain abstinent or use male contraceptives for 30 daysafter investigational agent administration. They are also strongly advised to informtheir non-pregnant sexual partners of reproductive potential to sue effectivecontraceptives for 30 days after investigational agent is administered to theparticipant. Participants with pregnant partners should use condoms during vaginalintercourse through 30 days after last dose of investigational agent administration.Participants should refrain from sperm donation for 30 days after investigationalagent administration (SNG001).

• Participants that engage in sexual activity that may lead to pregnancy in theirpartner must agree to either remain abstinent or use male contraceptives. They arealso strongly advised to inform their non-regnant sexual partners of reproductivepotential to use effective contraceptives from study entry through 90 days afterstudy treatment. Participants with pregnant partners should use condoms duringvaginal intercourse from study entry through 90 days after the last dose of thestudy treatment. Participants should refrain from sperm donation from study entrythrough 90 days after the last dose of study treatment (Camostat).

• If participating in sexual activity that could lead to pregnancy, participants whoare of reproductive potential must agree to use effective contraception for 24 weeksafter investigational agent is administered. This would include oral contraceptives,implanted contraceptives, implanted contraceptives, intrauterine devices, andbarrier methods.

• If participating in sexual activity that could lead to pregnancy, participants whoare 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 whoare of reproductive potential must agree to use effective contraception for 30 daysafter investigational agent is administered (SNG001).

• If participating in sexual activity that could lead to pregnancy, participants whoare of reproductive potential must agree to use effective contraception for 90 daysafter the last dose of treatment (Camostat).

• If participating in sexual activity that could lead to pregnancy, participants whoare of reproductive potential must agree to use highly effective contraception forat 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 orantigen tests from any respiratory tract specimen collected > 240 hours prior tostudy entry.

• Current need for hospitalization or immediate medical attention.

• Use of any prohibited medication listed in the protocol and/or use of systemic orinhaled steroids for the purpose of COVID-19 treatment (new or increased dose fromchronic baseline) within 30 days prior to study.

• Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2treatment or prophylaxis at any time prior to study entry.

• Receipt of other investigational treatments for SARS-CoV-2 any time beforeparticipating in the study (not including drugs approved and taken for otherconditions/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, orthat 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 ofprogression 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 theassessment 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 theassessment 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 IMinjection, or use of oral or injectable anticoagulants (protocol provides moreinformation 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 timesupper limit of normal or end stage liver disease with Child-Pugh Class C orChild-Pugh-Turcotte score ≥ 10) (Camostat).

• Known severe kidney disease prior to enrollment (defined as estimated glomerularfiltration rate (eGFR) <30 ml/min/1.73m² or on renal-replacement therapy such asperitoneal dialysis or hemodialysis (Camostat)

Other investigational drug protocol-defined inclusion/exclusion criteria may apply.