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

A. Moderate to Severe COVID-19 disease cases 1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 2. Understands and agrees to comply with planned study procedures. 3. Agrees to the collection of N-P, OP swabs, sputum and venous blood per protocol. 4. Male or non-pregnant female adult =18 years of age at time of enrolment. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen <7 days prior to randomization. 6. Illness of any duration, and at least one of the following: > 50% radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air OR requiring mechanical ventilation and/or supplemental oxygen. 7. If female of childbearing age, should agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site)

A. Moderate to Severe COVID-19 disease cases 1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 2. Understands and agrees to comply with planned study procedures. 3. Agrees to the collection of N-P, OP swabs, sputum and venous blood per protocol. 4. Male or non-pregnant female adult =18 years of age at time of enrolment. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen <7 days prior to randomization. 6. Illness of any duration, and at least one of the following: > 50% radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air OR requiring mechanical ventilation and/or supplemental oxygen. 7. If female of childbearing age, should agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site)