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

At least 18 years of age at the time of signing the ICF. Hospitalized for COVID-19. Diagnosed with COVID-19 as defined by having at least 2 of the following signs or symptoms within the past 2 days: a.fever defined as a body temperature higher than 38.0°C oral, or higher than 38.3°C rectal, higher than 37.7°C forehead or higher than 38.7°C aural (axillary temperatures are not allowable), b.cough, c.fatigue, d.shortness of breath. Radiographic evidence (chest x-ray or CT scan) of one the following: a. ground-glass opacities, or b.local or bilateral patchy infiltrates, or c.interstitial pulmonary infiltrates. Oxygen requirements: a. spO2 higher than 94% on ambient air or b.requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device. Male and/or female subjects. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All subjects (male or female) who are of childbearing potential must agree to use highly effective contraception during the study. Female subjects and male partners of female subjects must continue to use highly effective contraception for 30 days after the last dose of study drug. Female subjects should not donate oocytes during this time. Male subjects and female partners of male subjects must continue to use highly effective contraception for 90 days. Male subjects must agree not to donate sperm during this time. Women of childbearing potential must have a negative serum pregnancy test at screening within 72 hours prior to first administration of study drug. Women not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 1 year. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

At least 18 years of age at the time of signing the ICF. Hospitalized for COVID-19. Diagnosed with COVID-19 as defined by having at least 2 of the following signs or symptoms within the past 2 days: a.fever defined as a body temperature higher than 38.0°C oral, or higher than 38.3°C rectal, higher than 37.7°C forehead or higher than 38.7°C aural (axillary temperatures are not allowable), b.cough, c.fatigue, d.shortness of breath. Radiographic evidence (chest x-ray or CT scan) of one the following: a. ground-glass opacities, or b.local or bilateral patchy infiltrates, or c.interstitial pulmonary infiltrates. Oxygen requirements: a. spO2 higher than 94% on ambient air or b.requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device. Male and/or female subjects. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All subjects (male or female) who are of childbearing potential must agree to use highly effective contraception during the study. Female subjects and male partners of female subjects must continue to use highly effective contraception for 30 days after the last dose of study drug. Female subjects should not donate oocytes during this time. Male subjects and female partners of male subjects must continue to use highly effective contraception for 90 days. Male subjects must agree not to donate sperm during this time. Women of childbearing potential must have a negative serum pregnancy test at screening within 72 hours prior to first administration of study drug. Women not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 1 year. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol