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

* is currently hospitalized or is expected to need hospitalization for covid-19 within 48 hours of randomization. * is on dialysis or has reduced estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m\^2 by the modification of diet in renal disease (mdrd) equation. * has any of the following conditions: human immunodeficiency virus (hiv) with a recent viral load \>50 copies/ml (regardless of cd4 count) or an aids-defining illness in the past 6 months, participants with hiv may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count \<500/mm\^3. * has a history of hepatitis b virus (hbv) or hepatitis c virus (hcv) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \>3x upper limit of normal at screening. * has a platelet count \<100,000/μl or received a platelet transfusion in the 5 days prior to randomization. * is taking or is anticipated to require any prohibited therapies. * 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. * has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. * 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.

* is currently hospitalized or is expected to need hospitalization for covid-19 within 48 hours of randomization. * is on dialysis or has reduced estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m\^2 by the modification of diet in renal disease (mdrd) equation. * has any of the following conditions: human immunodeficiency virus (hiv) with a recent viral load \>50 copies/ml (regardless of cd4 count) or an aids-defining illness in the past 6 months, participants with hiv may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count \<500/mm\^3. * has a history of hepatitis b virus (hbv) or hepatitis c virus (hcv) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \>3x upper limit of normal at screening. * has a platelet count \<100,000/μl or received a platelet transfusion in the 5 days prior to randomization. * is taking or is anticipated to require any prohibited therapies. * 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. * has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. * 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.

May 29, 2021, 12:32 a.m. usa

- is currently hospitalized or is expected to need hospitalization for covid-19 within 48 hours of randomization. - is on dialysis or has reduced estimated glomerular filtration rate (egfr) <30 ml/min/1.73m^2 by the modification of diet in renal disease (mdrd) equation. - has any of the following conditions: human immunodeficiency virus (hiv) with a recent viral load >50 copies/ml (regardless of cd4 count) or an aids-defining illness in the past 6 months, participants with hiv may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count <500/mm^3. - has a history of hepatitis b virus (hbv) or hepatitis c virus (hcv) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x upper limit of normal at screening. - has a platelet count <100,000/μl or received a platelet transfusion in the 5 days prior to randomization. - is taking or is anticipated to require any prohibited therapies. - 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. - has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. - 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.

- is currently hospitalized or is expected to need hospitalization for covid-19 within 48 hours of randomization. - is on dialysis or has reduced estimated glomerular filtration rate (egfr) <30 ml/min/1.73m^2 by the modification of diet in renal disease (mdrd) equation. - has any of the following conditions: human immunodeficiency virus (hiv) with a recent viral load >50 copies/ml (regardless of cd4 count) or an aids-defining illness in the past 6 months, participants with hiv may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count <500/mm^3. - has a history of hepatitis b virus (hbv) or hepatitis c virus (hcv) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x upper limit of normal at screening. - has a platelet count <100,000/μl or received a platelet transfusion in the 5 days prior to randomization. - is taking or is anticipated to require any prohibited therapies. - 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. - has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. - 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.

Dec. 26, 2020, 12:31 a.m. usa

- is currently hospitalized or is expected to need hospitalization for covid-19 within 48 hours of randomization. - is on dialysis or has reduced estimated glomerular filtration rate (egfr) <30 ml/min/1.73m^2 by the modification of diet in renal disease (mdrd) equation. - has any of the following conditions: human immunodeficiency virus (hiv) with a recent viral load >50 copies/ml or cluster of differentiation 4 (cd4) <200 cell/mm^3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm^3; autologous or allogeneic hematopoietic stem cell transplant recipient. - has a history of hepatitis b virus (hbv) or hepatitis c virus (hcv) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x upper limit of normal at screening. - has a platelet count <100,000/μl or received a platelet transfusion in the 5 days prior to randomization. - has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. - is taking or is anticipated to require any prohibited therapies. - 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. - has a baseline heart rate of < 50 beats per minute at rest - has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. - 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, participants who are expected to require mechanical ventilation within 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.

- is currently hospitalized or is expected to need hospitalization for covid-19 within 48 hours of randomization. - is on dialysis or has reduced estimated glomerular filtration rate (egfr) <30 ml/min/1.73m^2 by the modification of diet in renal disease (mdrd) equation. - has any of the following conditions: human immunodeficiency virus (hiv) with a recent viral load >50 copies/ml or cluster of differentiation 4 (cd4) <200 cell/mm^3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm^3; autologous or allogeneic hematopoietic stem cell transplant recipient. - has a history of hepatitis b virus (hbv) or hepatitis c virus (hcv) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x upper limit of normal at screening. - has a platelet count <100,000/μl or received a platelet transfusion in the 5 days prior to randomization. - has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. - is taking or is anticipated to require any prohibited therapies. - 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. - has a baseline heart rate of < 50 beats per minute at rest - has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. - 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, participants who are expected to require mechanical ventilation within 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.

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

- is currently hospitalized or is expected to need hospitalization for covid-19 within 48 hours of randomization - is on dialysis or has reduced estimated glomerular filtration rate (egfr) <30 ml/min/1.73m^2 by the modification of diet in renal disease (mdrd) equation - has any of the following conditions: human immunodeficiency virus (hiv) with a recent viral load >50 copies/ml or cluster of differentiation 4 (cd4) <200 cell/mm^3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm^3; autologous or allogeneic hematopoietic stem cell transplant recipient - has an active diagnosis of hepatitis due to any cause - has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis - is taking or is anticipated to require any prohibited therapies - 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 - has a baseline heart rate of < 50 beats per minute at rest - has a platelet count <100,000/μl or received a platelet transfusion in the 5 days prior to randomization. - has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator - 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, participants who are expected to require mechanical ventilation within 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.

- is currently hospitalized or is expected to need hospitalization for covid-19 within 48 hours of randomization - is on dialysis or has reduced estimated glomerular filtration rate (egfr) <30 ml/min/1.73m^2 by the modification of diet in renal disease (mdrd) equation - has any of the following conditions: human immunodeficiency virus (hiv) with a recent viral load >50 copies/ml or cluster of differentiation 4 (cd4) <200 cell/mm^3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm^3; autologous or allogeneic hematopoietic stem cell transplant recipient - has an active diagnosis of hepatitis due to any cause - has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis - is taking or is anticipated to require any prohibited therapies - 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 - has a baseline heart rate of < 50 beats per minute at rest - has a platelet count <100,000/μl or received a platelet transfusion in the 5 days prior to randomization. - has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator - 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, participants who are expected to require mechanical ventilation within 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.