Created at Source Raw Value Validated value
Dec. 31, 2021, 5 a.m. usa

inclusion criteria: has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (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 consent; pcr positive in sample collected ≥ 72 hours prior to consent, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; at least 1 of the following symptoms: o fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; a pao2/fio2 ≤200 recorded in the 24 hours before consent. the pao2/fio2 can be imputed from pulse oximetry; oxygen therapy being administered via hfnc or niv the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a cxr or ct scan of the lungs; the patient is ≥18 years of age; a female patient of childbearing potential must not attempt to become pregnant for 180 days, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug; a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. a male patient must not donate sperm for 180 days; the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

inclusion criteria: has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (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 consent; pcr positive in sample collected ≥ 72 hours prior to consent, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; at least 1 of the following symptoms: o fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; a pao2/fio2 ≤200 recorded in the 24 hours before consent. the pao2/fio2 can be imputed from pulse oximetry; oxygen therapy being administered via hfnc or niv the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a cxr or ct scan of the lungs; the patient is ≥18 years of age; a female patient of childbearing potential must not attempt to become pregnant for 180 days, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug; a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. a male patient must not donate sperm for 180 days; the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.