Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures. <br/ > <br/ > Individuals �18 years of age. 4.1.1.3 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, NP, or nasal swab, or saliva) collected �240 hours prior to study entry and conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or any non-US DAIDS-approved laboratory. <br/ > <br/ > Participants must be expected to begin study treatment no more than 7 days from self-reported onset of COVID-19 related symptoms 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: <br/ > subjective fever or feeling feverish <br/ > <br/ > cough <br/ > <br/ > shortness of breath or difficulty breathing at <br/ > rest or with activity <br/ > <br/ > sore throat <br/ > <br/ > body pain or muscle pain/aches <br/ > <br/ > fatigue <br/ > <br/ > headache <br/ > <br/ > chills <br/ > <br/ > nasal obstruction or congestion <br/ > <br/ > nasal discharge <br/ > <br/ > loss of taste or smell <br/ > <br/ > nausea or vomiting <br/ > <br/ > diarrhea <br/ > <br/ > documented temperature >38°C <br/ > <br/ > One or more of the following signs/symptoms present within 24 hours prior to study entry: <br/ > <br/ > subjective fever or feeling feverish <br/ > <br/ > cough <br/ > <br/ > shortness of breath or difficulty breathing at rest or with activity <br/ > <br/ > sore throat <br/ > <br/ > body pain or muscle pain/aches <br/ > <br/ > fatigue <br/ > <br/ > headache <br/ > <br/ > chills <br/ > <br/ > nasal obstruction or congestion <br/ > <br/ > nasal discharge <br/ > <br/ > nausea or vomiting <br/ > <br/ > diarrhea <br/ > <br/ > documented temperature >38°C <br/ > <br/ > Oxygenation saturation of �92% obtained at rest by study staff within 24 hours prior to 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. <br/ > <br/ > Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest. <br/ > <br/ > Additional inclusion criteria as appropriate for the investigational agent <br/ > <br/ > For participants who are 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. <br/ > <br/ > Reproductive potential is defined as: <br/ > participant who has reached menarche <br/ > participant who has not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) level �40 IU/mL or 24 consecutive months if an FSH result is not <br/ > available participant who has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal <br/ > liga

Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures. <br/ > <br/ > Individuals �18 years of age. 4.1.1.3 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, NP, or nasal swab, or saliva) collected �240 hours prior to study entry and conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or any non-US DAIDS-approved laboratory. <br/ > <br/ > Participants must be expected to begin study treatment no more than 7 days from self-reported onset of COVID-19 related symptoms 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: <br/ > subjective fever or feeling feverish <br/ > <br/ > cough <br/ > <br/ > shortness of breath or difficulty breathing at <br/ > rest or with activity <br/ > <br/ > sore throat <br/ > <br/ > body pain or muscle pain/aches <br/ > <br/ > fatigue <br/ > <br/ > headache <br/ > <br/ > chills <br/ > <br/ > nasal obstruction or congestion <br/ > <br/ > nasal discharge <br/ > <br/ > loss of taste or smell <br/ > <br/ > nausea or vomiting <br/ > <br/ > diarrhea <br/ > <br/ > documented temperature >38°C <br/ > <br/ > One or more of the following signs/symptoms present within 24 hours prior to study entry: <br/ > <br/ > subjective fever or feeling feverish <br/ > <br/ > cough <br/ > <br/ > shortness of breath or difficulty breathing at rest or with activity <br/ > <br/ > sore throat <br/ > <br/ > body pain or muscle pain/aches <br/ > <br/ > fatigue <br/ > <br/ > headache <br/ > <br/ > chills <br/ > <br/ > nasal obstruction or congestion <br/ > <br/ > nasal discharge <br/ > <br/ > nausea or vomiting <br/ > <br/ > diarrhea <br/ > <br/ > documented temperature >38°C <br/ > <br/ > Oxygenation saturation of �92% obtained at rest by study staff within 24 hours prior to 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. <br/ > <br/ > Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest. <br/ > <br/ > Additional inclusion criteria as appropriate for the investigational agent <br/ > <br/ > For participants who are 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. <br/ > <br/ > Reproductive potential is defined as: <br/ > participant who has reached menarche <br/ > participant who has not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) level �40 IU/mL or 24 consecutive months if an FSH result is not <br/ > available participant who has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal <br/ > liga