Created at Source Raw Value Validated value
Feb. 4, 2021, 12:31 a.m. usa

- signs of acute respiratory distress syndrome or respiratory failure necessitating mechanical ventilation at time of screening/randomization or anticipated need for mechanical ventilation - history of severe chronic respiratory disease and requirement for long-term oxygen therapy - uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit - malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of screening - receipt of cancer chemotherapy or immunomodulatory drugs during preceding 2 months (steroids for treatment of covid-19 are acceptable) - current participation in other clinical trials including extended access programs - active deep vein thrombosis or pulmonary embolism within last 6 months - anticipated discharge from hospital or transfer to another hospital which is not a study site within 48 hours of admission - active uncontrolled co-morbid disease that may interfere with study conduct or interpretation of findings - known to be positive for hiv or positive test for chronic hbv infection or positive test for hepatitis c antibody - convalescent plasma (ccp) or anti-sars-cov-2 monoclonal antibodies administered <24 hours prior to randomization. must have recovered from any adverse events related to ccp treatment. received chloroquine or hydroxychloroquine within last 7 days or during the study - pregnancy or breast feeding

- signs of acute respiratory distress syndrome or respiratory failure necessitating mechanical ventilation at time of screening/randomization or anticipated need for mechanical ventilation - history of severe chronic respiratory disease and requirement for long-term oxygen therapy - uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit - malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of screening - receipt of cancer chemotherapy or immunomodulatory drugs during preceding 2 months (steroids for treatment of covid-19 are acceptable) - current participation in other clinical trials including extended access programs - active deep vein thrombosis or pulmonary embolism within last 6 months - anticipated discharge from hospital or transfer to another hospital which is not a study site within 48 hours of admission - active uncontrolled co-morbid disease that may interfere with study conduct or interpretation of findings - known to be positive for hiv or positive test for chronic hbv infection or positive test for hepatitis c antibody - convalescent plasma (ccp) or anti-sars-cov-2 monoclonal antibodies administered <24 hours prior to randomization. must have recovered from any adverse events related to ccp treatment. received chloroquine or hydroxychloroquine within last 7 days or during the study - pregnancy or breast feeding