Created at Source Raw Value Validated value
Oct. 26, 2020, 7:26 a.m. eu

1. Subject (≥18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures. When signed informed consent is not possible (e.g. due to restrictions to prevent viral transmission), verbal informed consent in the presence of a witness will be obtained and documented in the medical files. Signed informed consent will be obtained as soon as the safety concerns are mitigated. 2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 3. Male or non-pregnant female adult ≥18 years of age at time of enrolment. 4. Has a confirmed diagnosis of SARS-CoV-2 infection, defined as either: a. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization or b. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses 5. Illness of any duration, and at least one of the following: a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or b. Clinical assessment (evidence of rales/crackles on lung auscultation) AND SpO2 ≤ 94% on room air, or c. Requiring mechanical ventilation and/or supplemental oxygen.

1. Subject (≥18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures. When signed informed consent is not possible (e.g. due to restrictions to prevent viral transmission), verbal informed consent in the presence of a witness will be obtained and documented in the medical files. Signed informed consent will be obtained as soon as the safety concerns are mitigated. 2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 3. Male or non-pregnant female adult ≥18 years of age at time of enrolment. 4. Has a confirmed diagnosis of SARS-CoV-2 infection, defined as either: a. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization or b. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses 5. Illness of any duration, and at least one of the following: a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or b. Clinical assessment (evidence of rales/crackles on lung auscultation) AND SpO2 ≤ 94% on room air, or c. Requiring mechanical ventilation and/or supplemental oxygen.