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

inclusion criteria: * documented covid-19 infection (confirmed by nps positive pcr for sars-cov-2) with mild symptoms not requiring hospitalization * first nps ≤4 days (96 hours) since onset of symptoms * randomization ≤72 hours since first nps * adult males aged ≥ 50 years * indication for outpatient treatment but at high risk for complications, at least 1 risk factor (age ≥ 65 years, hypertension, diabetes, cardiovascular disease, active malignancy, copd) * who performance status 0-1 * adequate hematologic values: haemoglobin ≥ 100 g/l, neutrophils ≥ 1.0 x 10(9)/l, platelets ≥ 150 x 10(9)/l. * adequate hepatic function: alt and ast ≤ 2.5 x uln, bilirubin ≤ 1.5 x uln (exception if gilbert's syndrome ≤ 2.5 x uln) * adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of cockcroft-gault * patient is able to swallow the trial drugs and to comply with trial requirements * patient agrees not to father a child during participation in the trial and for 3 months thereafter

inclusion criteria: * documented covid-19 infection (confirmed by nps positive pcr for sars-cov-2) with mild symptoms not requiring hospitalization * first nps ≤4 days (96 hours) since onset of symptoms * randomization ≤72 hours since first nps * adult males aged ≥ 50 years * indication for outpatient treatment but at high risk for complications, at least 1 risk factor (age ≥ 65 years, hypertension, diabetes, cardiovascular disease, active malignancy, copd) * who performance status 0-1 * adequate hematologic values: haemoglobin ≥ 100 g/l, neutrophils ≥ 1.0 x 10(9)/l, platelets ≥ 150 x 10(9)/l. * adequate hepatic function: alt and ast ≤ 2.5 x uln, bilirubin ≤ 1.5 x uln (exception if gilbert's syndrome ≤ 2.5 x uln) * adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of cockcroft-gault * patient is able to swallow the trial drugs and to comply with trial requirements * patient agrees not to father a child during participation in the trial and for 3 months thereafter

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

inclusion criteria: - documented covid-19 infection (confirmed by nps positive pcr for sars-cov-2) with mild symptoms not requiring hospitalization - first nps ≤4 days (96 hours) since onset of symptoms - randomization ≤72 hours since first nps - adult males aged ≥ 50 years - indication for outpatient treatment but at high risk for complications, at least 1 risk factor (age ≥ 65 years, hypertension, diabetes, cardiovascular disease, active malignancy, copd) - who performance status 0-1 - adequate hematologic values: haemoglobin ≥ 100 g/l, neutrophils ≥ 1.0 x 10(9)/l, platelets ≥ 150 x 10(9)/l. - adequate hepatic function: alt and ast ≤ 2.5 x uln, bilirubin ≤ 1.5 x uln (exception if gilbert's syndrome ≤ 2.5 x uln) - adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of cockcroft-gault - patient is able to swallow the trial drugs and to comply with trial requirements - patient agrees not to father a child during participation in the trial and for 3 months thereafter

inclusion criteria: - documented covid-19 infection (confirmed by nps positive pcr for sars-cov-2) with mild symptoms not requiring hospitalization - first nps ≤4 days (96 hours) since onset of symptoms - randomization ≤72 hours since first nps - adult males aged ≥ 50 years - indication for outpatient treatment but at high risk for complications, at least 1 risk factor (age ≥ 65 years, hypertension, diabetes, cardiovascular disease, active malignancy, copd) - who performance status 0-1 - adequate hematologic values: haemoglobin ≥ 100 g/l, neutrophils ≥ 1.0 x 10(9)/l, platelets ≥ 150 x 10(9)/l. - adequate hepatic function: alt and ast ≤ 2.5 x uln, bilirubin ≤ 1.5 x uln (exception if gilbert's syndrome ≤ 2.5 x uln) - adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of cockcroft-gault - patient is able to swallow the trial drugs and to comply with trial requirements - patient agrees not to father a child during participation in the trial and for 3 months thereafter