Created at Source Raw Value Validated value
April 23, 2021, 1:30 a.m. eu

1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. 2. Is on dialysis or has reduced eGFR <30 mL/min/1.73 m2 (by the MDRD equation). 3. Has any of the following conditions: -HIV with a recent viral load >50 copies/mL or CD4 <200 cell/mm³ -Chemotherapy required within 6 weeks before randomization -A neutrophilic granulocyte absolute count <500/mm3 -Autologous or allogeneic hematopoietic stem cell transplant recipient 4. Has an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as HBsAg-positive) or HCV infection (defined as detectable HCV RNA). 5. Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. 6. Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. 7. Has a baseline heart rate of <50 beats per minute at rest. 8. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 9. 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: -Participants who are not expected to survive longer than 48 hours after randomization, or -Participants with a recent history of mechanical ventilation not associated with COVID-19, or -Participants with conditions that could limit gastrointestinal absorption of capsule contents. 10. Is taking or is anticipated to require any prohibited therapies as outlined in Protocol. 11. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. 12. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. 2. Is on dialysis or has reduced eGFR <30 mL/min/1.73 m2 (by the MDRD equation). 3. Has any of the following conditions: -HIV with a recent viral load >50 copies/mL or CD4 <200 cell/mm³ -Chemotherapy required within 6 weeks before randomization -A neutrophilic granulocyte absolute count <500/mm3 -Autologous or allogeneic hematopoietic stem cell transplant recipient 4. Has an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as HBsAg-positive) or HCV infection (defined as detectable HCV RNA). 5. Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. 6. Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. 7. Has a baseline heart rate of <50 beats per minute at rest. 8. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 9. 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: -Participants who are not expected to survive longer than 48 hours after randomization, or -Participants with a recent history of mechanical ventilation not associated with COVID-19, or -Participants with conditions that could limit gastrointestinal absorption of capsule contents. 10. Is taking or is anticipated to require any prohibited therapies as outlined in Protocol. 11. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. 12. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Feb. 12, 2021, 1:30 a.m. eu

1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. 2. Is on dialysis or has reduced eGFR <30 mL/min/1.73 m2 (by the MDRD equation). 3. Has any of the following conditions: -HIV with a recent viral load >50 copies/mL or CD4 <200 cell/mm³ -Chemotherapy required within 6 weeks before randomization -A neutrophilic granulocyte absolute count <500/mm3 -Autologous or allogeneic hematopoietic stem cell transplant recipient 4. Has a history of HBV or HCV infection with any of the following: Cirrhosis End-stage liver disease Hepatocellular carcinoma AST and/or ALT >3X upper limit of normal at screening 5. Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. 6. Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. 7. Has a baseline heart rate of <50 beats per minute at rest. 8. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 9. 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: -Participants who are not expected to survive longer than 48 hours after randomization, or -Participants with a recent history of mechanical ventilation, or -Participants with conditions that could limit gastrointestinal absorption of capsule contents. 10. Is taking or is anticipated to require any prohibited therapies as outlined in Protocol. 11. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. 12. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. 2. Is on dialysis or has reduced eGFR <30 mL/min/1.73 m2 (by the MDRD equation). 3. Has any of the following conditions: -HIV with a recent viral load >50 copies/mL or CD4 <200 cell/mm³ -Chemotherapy required within 6 weeks before randomization -A neutrophilic granulocyte absolute count <500/mm3 -Autologous or allogeneic hematopoietic stem cell transplant recipient 4. Has a history of HBV or HCV infection with any of the following: Cirrhosis End-stage liver disease Hepatocellular carcinoma AST and/or ALT >3X upper limit of normal at screening 5. Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. 6. Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. 7. Has a baseline heart rate of <50 beats per minute at rest. 8. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 9. 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: -Participants who are not expected to survive longer than 48 hours after randomization, or -Participants with a recent history of mechanical ventilation, or -Participants with conditions that could limit gastrointestinal absorption of capsule contents. 10. Is taking or is anticipated to require any prohibited therapies as outlined in Protocol. 11. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. 12. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Dec. 10, 2020, 1:30 a.m. eu

1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. 2. Is on dialysis or has reduced eGFR <30 mL/min/1.73 m2 (by the MDRD equation). 3. Has any of the following conditions: -HIV with a recent viral load >50 copies/mL or CD4 <200 cell/mm³ -Chemotherapy required within 6 weeks before randomization -A neutrophilic granulocyte absolute count <500/mm3 -Autologous or allogeneic hematopoietic stem cell transplant recipient 4. Has an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as HBsAg-positive) or HCV infection (defined as detectable HCV RNA). 5. Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. 6. Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. 7. Has a baseline heart rate of <50 beats per minute at rest. 8. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 9. 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: -Participants who are not expected to survive longer than 48 hours after randomization, or -Participants with a recent history of mechanical ventilation not associated with COVID-19, or -Participants with conditions that could limit gastrointestinal absorption of capsule contents. 10. Is taking or is anticipated to require any prohibited therapies as outlined in Protocol. 11. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. 12. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. 2. Is on dialysis or has reduced eGFR <30 mL/min/1.73 m2 (by the MDRD equation). 3. Has any of the following conditions: -HIV with a recent viral load >50 copies/mL or CD4 <200 cell/mm³ -Chemotherapy required within 6 weeks before randomization -A neutrophilic granulocyte absolute count <500/mm3 -Autologous or allogeneic hematopoietic stem cell transplant recipient 4. Has an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as HBsAg-positive) or HCV infection (defined as detectable HCV RNA). 5. Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. 6. Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. 7. Has a baseline heart rate of <50 beats per minute at rest. 8. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 9. 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: -Participants who are not expected to survive longer than 48 hours after randomization, or -Participants with a recent history of mechanical ventilation not associated with COVID-19, or -Participants with conditions that could limit gastrointestinal absorption of capsule contents. 10. Is taking or is anticipated to require any prohibited therapies as outlined in Protocol. 11. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. 12. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.