Created at Source Raw Value Validated value
Oct. 14, 2021, 1:55 p.m. eu

1. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition. 2. Positive test for SARS-CoV-2 within ≤5 days (if >1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test. 3. Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection. 4. Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5). 5. Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28. Information on which patient populations may benefit most from passive immune strategies targeting SARS-CoV-2 are limited. However, patients with impaired immune responses, whether from an underlying condition or the result of medical treatments, may have a delayed and/or reduced endogenous antibody response during COVID-19. Ongoing immunosuppressive condition or immunosuppressive treatment, includes: Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy Antirejection medicine after solid organ or stem cell transplantation Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months Primary or acquired severe B- or T-lymphocyte immune dysfunction HIV infection Splenectomy or functional asplenia

1. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition. 2. Positive test for SARS-CoV-2 within ≤5 days (if >1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test. 3. Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection. 4. Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5). 5. Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28. Information on which patient populations may benefit most from passive immune strategies targeting SARS-CoV-2 are limited. However, patients with impaired immune responses, whether from an underlying condition or the result of medical treatments, may have a delayed and/or reduced endogenous antibody response during COVID-19. Ongoing immunosuppressive condition or immunosuppressive treatment, includes: Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy Antirejection medicine after solid organ or stem cell transplantation Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months Primary or acquired severe B- or T-lymphocyte immune dysfunction HIV infection Splenectomy or functional asplenia