Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

Subjects must meet all the following inclusion criteria to be eligible for enrollment in the study. 1. Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations. 2. Age of &#8805, 18 years 3. Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization 4. Hospitalized for SARS-CoV-2 (2019-nCoV) 5. Bilateral pneumonia on chest x-ray or computed tomography (CT) 6. Active fever or recently documented fever within 72 hours prior to randomization (&#8805,100.4°F or &#8805,38°C) 7. At least one of the following: • Ferritin > 500 ng/mL • CRP > 5 mg/dL • D-dimer > 1,000 ng/mL • LDH > 250 U/L 8. Cohort 1: Receiving any form of non-invasive ventilation OR oxygenation to maintain SpO2 &#8805, 92% and not-intubated [examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, and non-invasive ventilation (NIV) or non-invasive positive pressure ventilation (NIPPV)] 9. Cohort 2: Recently ventilated with mechanical ventilation beginning within 48 hours prior to randomization

Subjects must meet all the following inclusion criteria to be eligible for enrollment in the study. 1. Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations. 2. Age of &#8805, 18 years 3. Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization 4. Hospitalized for SARS-CoV-2 (2019-nCoV) 5. Bilateral pneumonia on chest x-ray or computed tomography (CT) 6. Active fever or recently documented fever within 72 hours prior to randomization (&#8805,100.4°F or &#8805,38°C) 7. At least one of the following: • Ferritin > 500 ng/mL • CRP > 5 mg/dL • D-dimer > 1,000 ng/mL • LDH > 250 U/L 8. Cohort 1: Receiving any form of non-invasive ventilation OR oxygenation to maintain SpO2 &#8805, 92% and not-intubated [examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, and non-invasive ventilation (NIV) or non-invasive positive pressure ventilation (NIPPV)] 9. Cohort 2: Recently ventilated with mechanical ventilation beginning within 48 hours prior to randomization