Created at Source Raw Value Validated value
March 31, 2021, 4:03 p.m. oms

1. Written informed consent signed and dated by the study subject or their legal representatives 2. Age =18 years old 3. Female or male patients with laboratory-confirmed symptomatic COVID-19 (SARS-CoV-2 infection) as determined by polymerase chain reaction (PCR) assay in any specimen collected <72 hours before randomization 4. Patients with any category of the following disease severity: 4.1. Moderate: 4.1.1. Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion 4.1.2. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate =20 breaths per minute, saturation of oxygen (SpO2) ?90% on room air at sea level, heart rate =90 beats per minute 4.1.3. No clinical signs indicative of severe or critical illness severity 4.2. Severe (not critical): meeting the following criteria: 4.2.1 Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress 4.2.2. Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate =30 per minute, heart rate =125 per minute, SpO2 =90% on room air at sea level or PaO2/FiO2 <300 4.2.3. No criteria for critical severity 5. Radiographic evidence of pulmonary infiltrate

1. Written informed consent signed and dated by the study subject or their legal representatives 2. Age =18 years old 3. Female or male patients with laboratory-confirmed symptomatic COVID-19 (SARS-CoV-2 infection) as determined by polymerase chain reaction (PCR) assay in any specimen collected <72 hours before randomization 4. Patients with any category of the following disease severity: 4.1. Moderate: 4.1.1. Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion 4.1.2. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate =20 breaths per minute, saturation of oxygen (SpO2) ?90% on room air at sea level, heart rate =90 beats per minute 4.1.3. No clinical signs indicative of severe or critical illness severity 4.2. Severe (not critical): meeting the following criteria: 4.2.1 Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress 4.2.2. Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate =30 per minute, heart rate =125 per minute, SpO2 =90% on room air at sea level or PaO2/FiO2 <300 4.2.3. No criteria for critical severity 5. Radiographic evidence of pulmonary infiltrate