Created at Source Raw Value Validated value
May 11, 2022, 6 a.m. usa

inclusion criteria: at least 18 years of age at screening; confirmed sars-cov-2 viral infection by polymerase chain reaction (pcr) within 48 hours prior to first administration; hospitalized patients who are symptomatic (phase 1) and require respiratory support (phase 2); off antiviral medications for at least 7 days prior to first dose of study drug. (antiviral agents directed for another ongoing non-sars-cov-2 infection such as valtrex (valacyclovir hydrochloride) for herpes simplex virus lesions are allowed; written informed consent from the patient or legally authorized representative (lar), if the patient is not able to provide informed consent due to severity of illness; women of childbearing potential (wcbp) must have a negative serum pregnancy test at screening; wcbp must agree to abstain from sex or use an adequate method of contraception* from the time of informed consent through the final in-person evaluations at day 38 (± 3 days); males must abstain from sex with wcbp or use an adequate method of contraception* from the time of informed consent through the final in-person evaluations at day 38 (± 3 days).

inclusion criteria: at least 18 years of age at screening; confirmed sars-cov-2 viral infection by polymerase chain reaction (pcr) within 48 hours prior to first administration; hospitalized patients who are symptomatic (phase 1) and require respiratory support (phase 2); off antiviral medications for at least 7 days prior to first dose of study drug. (antiviral agents directed for another ongoing non-sars-cov-2 infection such as valtrex (valacyclovir hydrochloride) for herpes simplex virus lesions are allowed; written informed consent from the patient or legally authorized representative (lar), if the patient is not able to provide informed consent due to severity of illness; women of childbearing potential (wcbp) must have a negative serum pregnancy test at screening; wcbp must agree to abstain from sex or use an adequate method of contraception* from the time of informed consent through the final in-person evaluations at day 38 (± 3 days); males must abstain from sex with wcbp or use an adequate method of contraception* from the time of informed consent through the final in-person evaluations at day 38 (± 3 days).