Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1. Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx and Throat) test shall be repeated to assess eligibility. <br/ >2. Symptomatic male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-85 years of age at time of enrollment. <br/ >3. Illness or condition of any duration, and at least one of the following: <br/ > - Fever defined as temperature greater than or equal to 36.6C (98.4F) measured by an infrared body temperature detection device. <br/ > - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR <br/ > - Clinical assessment (evidence of rales/crackles on exam) AND SpO2 less than or equal to 94% on room air, OR <br/ > - Requiring supplemental oxygen, OR <br/ > - Requiring mechanical ventilation. <br/ >4. Women of childbearing potential must agree to either abstain or use at <br/ >least one primary form of contraception not including hormonal contraception from the time of screening to the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ >5. Agrees to not participate in another clinical trial for the treatment of COVID-19 until the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ >6. Subject (or legally authorized representative) providing written informed consent prior to initiation of any study procedures. <br/ >7. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required. <br/ >

1. Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx and Throat) test shall be repeated to assess eligibility. <br/ >2. Symptomatic male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-85 years of age at time of enrollment. <br/ >3. Illness or condition of any duration, and at least one of the following: <br/ > - Fever defined as temperature greater than or equal to 36.6C (98.4F) measured by an infrared body temperature detection device. <br/ > - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR <br/ > - Clinical assessment (evidence of rales/crackles on exam) AND SpO2 less than or equal to 94% on room air, OR <br/ > - Requiring supplemental oxygen, OR <br/ > - Requiring mechanical ventilation. <br/ >4. Women of childbearing potential must agree to either abstain or use at <br/ >least one primary form of contraception not including hormonal contraception from the time of screening to the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ >5. Agrees to not participate in another clinical trial for the treatment of COVID-19 until the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ >6. Subject (or legally authorized representative) providing written informed consent prior to initiation of any study procedures. <br/ >7. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required. <br/ >

Nov. 13, 2021, 5:33 p.m. oms

Oct. 26, 2020, 8:29 a.m. oms

1. Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx and Throat) test shall be repeated to assess eligibility. <br/ >2. Symptomatic male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-85 years of age at time of enrollment. <br/ >3. Illness or condition of any duration, and at least one of the following: <br/ > - Fever defined as temperature greater than or equal to 36.6C (98.4F) measured by an infrared body temperature detection device. <br/ > - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR <br/ > - Clinical assessment (evidence of rales/crackles on exam) AND SpO2 less than or equal to 94% on room air, OR <br/ > - Requiring supplemental oxygen, OR <br/ > - Requiring mechanical ventilation. <br/ >4. Women of childbearing potential must agree to either abstain or use at <br/ >least one primary form of contraception not including hormonal contraception from the time of screening to the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ >5. Agrees to not participate in another clinical trial for the treatment of COVID-19 until the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ >6. Subject (or legally authorized representative) providing written informed consent prior to initiation of any study procedures. <br/ >7. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required. <br/ >

1. Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx and Throat) test shall be repeated to assess eligibility. <br/ >2. Symptomatic male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-85 years of age at time of enrollment. <br/ >3. Illness or condition of any duration, and at least one of the following: <br/ > - Fever defined as temperature greater than or equal to 36.6C (98.4F) measured by an infrared body temperature detection device. <br/ > - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR <br/ > - Clinical assessment (evidence of rales/crackles on exam) AND SpO2 less than or equal to 94% on room air, OR <br/ > - Requiring supplemental oxygen, OR <br/ > - Requiring mechanical ventilation. <br/ >4. Women of childbearing potential must agree to either abstain or use at <br/ >least one primary form of contraception not including hormonal contraception from the time of screening to the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ >5. Agrees to not participate in another clinical trial for the treatment of COVID-19 until the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ >6. Subject (or legally authorized representative) providing written informed consent prior to initiation of any study procedures. <br/ >7. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required. <br/ >