Created at Source Raw Value Validated value
July 29, 2021, 4:30 p.m. eu

MEDICAL CONDITIONS 1. Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours 2. Symptoms consistent with severe COVID-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen 3. Participants who, in the judgement of the investigator are likely to die in the next 7 days. 4. Known hypersensitivity to any constituent present in the investigational product PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE 5. Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer 6. Enrollment in any trial of an investigational drug, vaccine or device study for SARS-CoV-2/COVID-19 within 90 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer OTHER EXCLUSIONS 7. Receipt of convalescent plasma from a recovered COVID-19 patient or anti SARS-CoV-2 mAb within the last 3 months. 8. Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol through Day 29 NOTE: Previous receipt of a SARS-CoV-2/COVID-19 vaccine is NOT an exclusion criteria

MEDICAL CONDITIONS 1. Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours 2. Symptoms consistent with severe COVID-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen 3. Participants who, in the judgement of the investigator are likely to die in the next 7 days. 4. Known hypersensitivity to any constituent present in the investigational product PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE 5. Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer 6. Enrollment in any trial of an investigational drug, vaccine or device study for SARS-CoV-2/COVID-19 within 90 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer OTHER EXCLUSIONS 7. Receipt of convalescent plasma from a recovered COVID-19 patient or anti SARS-CoV-2 mAb within the last 3 months. 8. Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol through Day 29 NOTE: Previous receipt of a SARS-CoV-2/COVID-19 vaccine is NOT an exclusion criteria