Created at Source Raw Value Validated value
March 18, 2022, 5:30 p.m. eu

1. Participants ≥18 years of age (or the minimum country-specific age of consent if >18) at the time of the Screening Visit. - WOCBP may be enrolled. - All fertile participants must agree to use a highly effective method of contraception. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. 2.Confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen collected within 5 days prior to randomization. Note: RT-PCR is the preferred method, however, with evolving approaches to confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed. The test result must be available to confirm eligibility. Participants may be enrolled based on positive results of a rapid SARS-CoV-2 antigen test performed at screening. 3.Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization (see Appendix 9 for criteria). 4.Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19 including: - ≥60 years of age, - BMI >25, - Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes, - Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications: o Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry. o Has received treatment with biologics (eg, infliximab, ustekinumab), immunomodulators (eg, methotrexate, 6MP, azathioprine) or cancer chemotherapy within 90 days prior to study entry. o HIV infection with CD4 cell count <200 mm3 and a viral load less than 400 copies/mL - Chronic lung disease (if asthma, requires daily prescribed therapy), - Known diagnosis of hypertension, - CVD, defined as history of any of the following: myocardial infarction, stroke, TIA, HF, angina with prescribed nitroglycerin, CABG, PCI, carotid endarterectomy, and aortic bypass, - Type 1 or Type 2 diabetes mellitus, - CKD provided the participant does not meet Exclusion Criterion 5, - Sickle cell disease, - Neurodevelopmental disorders (eg, cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes and severe congenital anomalies), - Active cancer, other than localized skin cancer, including those requiring treatment as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period, - Medical-related technological dependence (eg, CPAP [not related to COVID-19]). 5. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 6. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

1. Participants ≥18 years of age (or the minimum country-specific age of consent if >18) at the time of the Screening Visit. - WOCBP may be enrolled. - All fertile participants must agree to use a highly effective method of contraception. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. 2.Confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen collected within 5 days prior to randomization. Note: RT-PCR is the preferred method, however, with evolving approaches to confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed. The test result must be available to confirm eligibility. Participants may be enrolled based on positive results of a rapid SARS-CoV-2 antigen test performed at screening. 3.Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization (see Appendix 9 for criteria). 4.Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19 including: - ≥60 years of age, - BMI >25, - Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes, - Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications: o Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry. o Has received treatment with biologics (eg, infliximab, ustekinumab), immunomodulators (eg, methotrexate, 6MP, azathioprine) or cancer chemotherapy within 90 days prior to study entry. o HIV infection with CD4 cell count <200 mm3 and a viral load less than 400 copies/mL - Chronic lung disease (if asthma, requires daily prescribed therapy), - Known diagnosis of hypertension, - CVD, defined as history of any of the following: myocardial infarction, stroke, TIA, HF, angina with prescribed nitroglycerin, CABG, PCI, carotid endarterectomy, and aortic bypass, - Type 1 or Type 2 diabetes mellitus, - CKD provided the participant does not meet Exclusion Criterion 5, - Sickle cell disease, - Neurodevelopmental disorders (eg, cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes and severe congenital anomalies), - Active cancer, other than localized skin cancer, including those requiring treatment as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period, - Medical-related technological dependence (eg, CPAP [not related to COVID-19]). 5. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 6. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.