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

1.Admitted to a hospital with symptoms suggestive of COVID-19 infection.2.Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.3.Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.4.Male or non-pregnant female adult =>18 years of age at time of enrollment.5.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following -PCR positive in sample collected < 72 hours prior to randomization OR -PCR positive in sample collected => 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.). AND progressive disease suggestive of ongoing SARS-CoV-2 infection.6.Illness of any duration, and at least one of the following-Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR-SpO2 <= 94% on room air, OR-Requiring supplemental oxygen, OR-Requiring mechanical ventilation.7.Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. 8.Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.

1.Admitted to a hospital with symptoms suggestive of COVID-19 infection.2.Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.3.Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.4.Male or non-pregnant female adult =>18 years of age at time of enrollment.5.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following -PCR positive in sample collected < 72 hours prior to randomization OR -PCR positive in sample collected => 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.). AND progressive disease suggestive of ongoing SARS-CoV-2 infection.6.Illness of any duration, and at least one of the following-Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR-SpO2 <= 94% on room air, OR-Requiring supplemental oxygen, OR-Requiring mechanical ventilation.7.Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. 8.Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.