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

Subjects will be entered into the study only if they meet none of the following criteria <br/ > <br/ >1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization <br/ > <br/ >2. Pregnancy or lactation <br/ > <br/ >3. History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment <br/ > <br/ >4. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation <br/ > <br/ >5. Tested positive for Human immunodeficiency virus (HIV), <br/ > Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection <br/ > <br/ >6. Abnormal laboratory findings at screening <br/ >Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >Absolute neutrophil count <500/mm3 or per microliter <br/ >Platelet count <100,000 per microliter or /mm3 <br/ >Patients who received a platelet transfusion in the 5 days prior to randomization <br/ > <br/ >7. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: <br/ > <br/ >8. Participants who are not expected to survive longer than 48 hours at the time of randomization, or <br/ >Participants with a recent history of mechanical ventilation, or <br/ >Participants with conditions that could limit gastrointestinal absorption of capsule contents <br/ > <br/ >9. Receipt of following medication/treatment: <br/ >Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment <br/ >Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit) <br/ > <br/ >10. Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer) <br/ >

Subjects will be entered into the study only if they meet none of the following criteria <br/ > <br/ >1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization <br/ > <br/ >2. Pregnancy or lactation <br/ > <br/ >3. History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment <br/ > <br/ >4. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation <br/ > <br/ >5. Tested positive for Human immunodeficiency virus (HIV), <br/ > Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection <br/ > <br/ >6. Abnormal laboratory findings at screening <br/ >Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >Absolute neutrophil count <500/mm3 or per microliter <br/ >Platelet count <100,000 per microliter or /mm3 <br/ >Patients who received a platelet transfusion in the 5 days prior to randomization <br/ > <br/ >7. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: <br/ > <br/ >8. Participants who are not expected to survive longer than 48 hours at the time of randomization, or <br/ >Participants with a recent history of mechanical ventilation, or <br/ >Participants with conditions that could limit gastrointestinal absorption of capsule contents <br/ > <br/ >9. Receipt of following medication/treatment: <br/ >Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment <br/ >Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit) <br/ > <br/ >10. Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer) <br/ >

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

N/A

N/A

Sept. 8, 2021, 1:30 a.m. oms

Subjects will be entered into the study only if they meet none of the following criteria <br/ > <br/ >1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization <br/ > <br/ >2. Pregnancy or lactation <br/ > <br/ >3. History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment <br/ > <br/ >4. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation <br/ > <br/ >5. Tested positive for Human immunodeficiency virus (HIV), <br/ > Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection <br/ > <br/ >6. Abnormal laboratory findings at screening <br/ >Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >Absolute neutrophil count <500/mm3 or per microliter <br/ >Platelet count <100,000 per microliter or /mm3 <br/ >Patients who received a platelet transfusion in the 5 days prior to randomization <br/ > <br/ >7. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: <br/ > <br/ >8. Participants who are not expected to survive longer than 48 hours at the time of randomization, or <br/ >Participants with a recent history of mechanical ventilation, or <br/ >Participants with conditions that could limit gastrointestinal absorption of capsule contents <br/ > <br/ >9. Receipt of following medication/treatment: <br/ >Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment <br/ >Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit) <br/ > <br/ >10. Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer) <br/ >

Subjects will be entered into the study only if they meet none of the following criteria <br/ > <br/ >1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization <br/ > <br/ >2. Pregnancy or lactation <br/ > <br/ >3. History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment <br/ > <br/ >4. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation <br/ > <br/ >5. Tested positive for Human immunodeficiency virus (HIV), <br/ > Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection <br/ > <br/ >6. Abnormal laboratory findings at screening <br/ >Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >Absolute neutrophil count <500/mm3 or per microliter <br/ >Platelet count <100,000 per microliter or /mm3 <br/ >Patients who received a platelet transfusion in the 5 days prior to randomization <br/ > <br/ >7. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: <br/ > <br/ >8. Participants who are not expected to survive longer than 48 hours at the time of randomization, or <br/ >Participants with a recent history of mechanical ventilation, or <br/ >Participants with conditions that could limit gastrointestinal absorption of capsule contents <br/ > <br/ >9. Receipt of following medication/treatment: <br/ >Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment <br/ >Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit) <br/ > <br/ >10. Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer) <br/ >