Created at Source Raw Value Validated value
Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: - able to comprehend and be willing to sign the institutional review board (irb)-approved subject informed consent form (icf) prior to administration of any study-related procedures, or consent from surrogate decision maker when the above criteria cannot be met - male or non-pregnant female adult ≥18 years of age at time of enrollment; female patients must have a negative serum pregnancy test at study enrollment - has laboratory-confirmed covid-19 coronavirus infection as determined by polymerase chain reaction (pcr), or other commercial or public health assay in oropharyngeal or nasopharyngeal testing within 14 days of hospitalization. an additional 24-hour covid-19 pcr test will be performed at kumc. patients outside of kumc will have their samples sent to kumc as a central lab for test processing - hospitalized as a result of symptoms and signs related to covid-19 infection, and ≤14 days since positive test - evidence of hypoxic respiratory failure: spo2≤93% on room air, or spo2 >93% requiring ≥ 2 liters (l) o2, or pa02/fi02 ratio <300 millimeter of mercury (mmhg), or tachypnea (respiratory rate > 30 breaths/min) - evidence of pulmonary involvement by: chest imaging or pulmonary exam - previous use of hydroxychloroquine or chloroquine is allowed in this study - adequate organ function per laboratory tests - females of child-bearing potential and males with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in child-bearing potential/pregnancy section for the duration of study participation and for 30 days for females and 90 days for males following completion of therapy

inclusion criteria: - able to comprehend and be willing to sign the institutional review board (irb)-approved subject informed consent form (icf) prior to administration of any study-related procedures, or consent from surrogate decision maker when the above criteria cannot be met - male or non-pregnant female adult ≥18 years of age at time of enrollment; female patients must have a negative serum pregnancy test at study enrollment - has laboratory-confirmed covid-19 coronavirus infection as determined by polymerase chain reaction (pcr), or other commercial or public health assay in oropharyngeal or nasopharyngeal testing within 14 days of hospitalization. an additional 24-hour covid-19 pcr test will be performed at kumc. patients outside of kumc will have their samples sent to kumc as a central lab for test processing - hospitalized as a result of symptoms and signs related to covid-19 infection, and ≤14 days since positive test - evidence of hypoxic respiratory failure: spo2≤93% on room air, or spo2 >93% requiring ≥ 2 liters (l) o2, or pa02/fi02 ratio <300 millimeter of mercury (mmhg), or tachypnea (respiratory rate > 30 breaths/min) - evidence of pulmonary involvement by: chest imaging or pulmonary exam - previous use of hydroxychloroquine or chloroquine is allowed in this study - adequate organ function per laboratory tests - females of child-bearing potential and males with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in child-bearing potential/pregnancy section for the duration of study participation and for 30 days for females and 90 days for males following completion of therapy