Created at Source Raw Value Validated value
Jan. 29, 2022, 11:30 a.m. usa

inclusion criteria: admitted to a hospital with pulmonary symptoms of active covid-19. patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures. patient (or legally authorized representative) understands and agrees to comply with planned study procedures. male or nonpregnant female adult ≥18 years of age at time of enrollment. has laboratory confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (serology is not acceptable) in any specimen, as documented by either of the following: laboratory confirmed sars-cov-2 infection by method as defined above, in sample collected <72 hours prior to randomization; or laboratory confirmed sars-cov-2 infection by method as defined above, 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. has a score of 4 (hospitalized, oxygen by mask or nasal prongs), 5 (hospitalized, noninvasive ventilation or high-flow oxygen), or 6 (hospitalized, intubation and mechanical ventilation) in the ordinal scale. women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception not including hormonal contraception from the time of screening through day 29. (double-barrier method [condoms, sponge, diaphragm, with spermicidal jellies, or cream] is acceptable). agrees to not participate in another clinical study for the treatment of covid-19 or sars-cov-2 through day 29. however, food and drug administration (fda)-approved or under an emergency use authorization antivirus or other drugs may be allowed, and that should be judged by the patient's physician.

inclusion criteria: admitted to a hospital with pulmonary symptoms of active covid-19. patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures. patient (or legally authorized representative) understands and agrees to comply with planned study procedures. male or nonpregnant female adult ≥18 years of age at time of enrollment. has laboratory confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (serology is not acceptable) in any specimen, as documented by either of the following: laboratory confirmed sars-cov-2 infection by method as defined above, in sample collected <72 hours prior to randomization; or laboratory confirmed sars-cov-2 infection by method as defined above, 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. has a score of 4 (hospitalized, oxygen by mask or nasal prongs), 5 (hospitalized, noninvasive ventilation or high-flow oxygen), or 6 (hospitalized, intubation and mechanical ventilation) in the ordinal scale. women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception not including hormonal contraception from the time of screening through day 29. (double-barrier method [condoms, sponge, diaphragm, with spermicidal jellies, or cream] is acceptable). agrees to not participate in another clinical study for the treatment of covid-19 or sars-cov-2 through day 29. however, food and drug administration (fda)-approved or under an emergency use authorization antivirus or other drugs may be allowed, and that should be judged by the patient's physician.