Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: * confirmed infection with sars-cov-2 per world health organization (who) criteria (including positive rt-pcr nucleic acid test of any specimen \[eg, respiratory, blood, urine, stool, or other bodily fluid\]) within 7 days of randomization * hospitalized with covid-19 pneumonia (documented radiographically) and oxygen saturation \<94% on room air or subject requires supplemental oxygen * able to swallow capsules * willing to follow contraception guidelines * subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. however, if obtaining written informed consent is not possible, other procedures as provided in the march 27th, 2020 fda guidance on conduct of clinical trials of medical products during covid-19 pandemic, question 10, may be used

inclusion criteria: * confirmed infection with sars-cov-2 per world health organization (who) criteria (including positive rt-pcr nucleic acid test of any specimen \[eg, respiratory, blood, urine, stool, or other bodily fluid\]) within 7 days of randomization * hospitalized with covid-19 pneumonia (documented radiographically) and oxygen saturation \<94% on room air or subject requires supplemental oxygen * able to swallow capsules * willing to follow contraception guidelines * subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. however, if obtaining written informed consent is not possible, other procedures as provided in the march 27th, 2020 fda guidance on conduct of clinical trials of medical products during covid-19 pandemic, question 10, may be used

Nov. 21, 2020, 12:31 a.m. usa

inclusion criteria: - confirmed infection with sars-cov-2 per world health organization (who) criteria (including positive rt-pcr nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization - hospitalized with covid-19 pneumonia (documented radiographically) and oxygen saturation <94% on room air or subject requires supplemental oxygen - able to swallow capsules - willing to follow contraception guidelines - subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. however, if obtaining written informed consent is not possible, other procedures as provided in the march 27th, 2020 fda guidance on conduct of clinical trials of medical products during covid-19 pandemic, question 10, may be used

inclusion criteria: - confirmed infection with sars-cov-2 per world health organization (who) criteria (including positive rt-pcr nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization - hospitalized with covid-19 pneumonia (documented radiographically) and oxygen saturation <94% on room air or subject requires supplemental oxygen - able to swallow capsules - willing to follow contraception guidelines - subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. however, if obtaining written informed consent is not possible, other procedures as provided in the march 27th, 2020 fda guidance on conduct of clinical trials of medical products during covid-19 pandemic, question 10, may be used

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: - confirmed infection with sars-cov-2 per world health organization (who) criteria (including positive rt-pcr nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization - covid-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or subject requires supplemental oxygen - able to swallow capsules - willing to follow contraception guidelines - subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. however, if obtaining written informed consent is not possible, other procedures as provided in the march 27th, 2020 fda guidance on conduct of clinical trials of medical products during covid-19 pandemic, question 10, may be used

inclusion criteria: - confirmed infection with sars-cov-2 per world health organization (who) criteria (including positive rt-pcr nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization - covid-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or subject requires supplemental oxygen - able to swallow capsules - willing to follow contraception guidelines - subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. however, if obtaining written informed consent is not possible, other procedures as provided in the march 27th, 2020 fda guidance on conduct of clinical trials of medical products during covid-19 pandemic, question 10, may be used