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

* hypersensitivity to the study drug components. * lactase deficiency, lactose intolerance, glucose-galactose malabsorption. * use of direct-acting antiviral drugs within 10 days prior to screening. * the use of drugs at the time of screening whose clearance is highly dependent on the cyp3a isoenzyme, or which are strong inducers of cyp3a (for more information, see the section "unauthorized pharmaceuticals"). * necessity to use unauthorized pharmaceuticals. * the need for oxygen therapy at the time of screening. * hospitalization required at time of screening, or hospitalization expected to be required for covid-19 within 48 hours of randomization, excluding hospitalization to the observation facility for social reasons (e. g., living in a hostel, cohabiting with people, including those with risk factors for aggravated covid-19, who, after contact with the patient, have a negative result for the sars-cov-2 rna/antigen, etc.). * severe and extremely severe disease signs as of the time of screening. * vaccination within less than 4 weeks prior to screening. * possible or confirmed moderate covid-19 within 6 months prior to screening. * possible or confirmed history of severe or very severe covid-19. * patients with moderate to severe renal insufficiency (estimated glomerular filtration rate (gfr) \< 60 ml/min/1.73 m2 per ckd-epi formula) or receiving renal replacement therapy at the time of screening. * severe liver failure (class c per child-pugh) at the time of screening or elevated alt and/or ast levels of ≥ 2.5 unl and/or elevated total bilirubin levels of ≥ 2 unl (≥ 3 unl with gilbert's syndrome) in past medical history (within 6 months prior to screening). * positive test result for hiv, syphilis, hepatitis b and/or c at the time of screening. * alcohol, pharmacological and/or drug dependence (history and/or at the time of screening). * schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening. * any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the patient due to his/her participation in the study. * unwillingness or inability of a patient to comply with the protocol procedures (in the opinion of the investigator). * pregnant or lactating women, or women planning a pregnancy. * participation in another clinical study within 3 months prior to enrolment in the present study. * other conditions that prevent the patient from inclusion in the study.

* hypersensitivity to the study drug components. * lactase deficiency, lactose intolerance, glucose-galactose malabsorption. * use of direct-acting antiviral drugs within 10 days prior to screening. * the use of drugs at the time of screening whose clearance is highly dependent on the cyp3a isoenzyme, or which are strong inducers of cyp3a (for more information, see the section "unauthorized pharmaceuticals"). * necessity to use unauthorized pharmaceuticals. * the need for oxygen therapy at the time of screening. * hospitalization required at time of screening, or hospitalization expected to be required for covid-19 within 48 hours of randomization, excluding hospitalization to the observation facility for social reasons (e. g., living in a hostel, cohabiting with people, including those with risk factors for aggravated covid-19, who, after contact with the patient, have a negative result for the sars-cov-2 rna/antigen, etc.). * severe and extremely severe disease signs as of the time of screening. * vaccination within less than 4 weeks prior to screening. * possible or confirmed moderate covid-19 within 6 months prior to screening. * possible or confirmed history of severe or very severe covid-19. * patients with moderate to severe renal insufficiency (estimated glomerular filtration rate (gfr) \< 60 ml/min/1.73 m2 per ckd-epi formula) or receiving renal replacement therapy at the time of screening. * severe liver failure (class c per child-pugh) at the time of screening or elevated alt and/or ast levels of ≥ 2.5 unl and/or elevated total bilirubin levels of ≥ 2 unl (≥ 3 unl with gilbert's syndrome) in past medical history (within 6 months prior to screening). * positive test result for hiv, syphilis, hepatitis b and/or c at the time of screening. * alcohol, pharmacological and/or drug dependence (history and/or at the time of screening). * schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening. * any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the patient due to his/her participation in the study. * unwillingness or inability of a patient to comply with the protocol procedures (in the opinion of the investigator). * pregnant or lactating women, or women planning a pregnancy. * participation in another clinical study within 3 months prior to enrolment in the present study. * other conditions that prevent the patient from inclusion in the study.

Nov. 3, 2022, 4 a.m. usa

hypersensitivity to the study drug components. lactase deficiency, lactose intolerance, glucose-galactose malabsorption. use of direct-acting antiviral drugs within 10 days prior to screening. the use of drugs at the time of screening whose clearance is highly dependent on the cyp3a isoenzyme, or which are strong inducers of cyp3a (for more information, see the section "unauthorized pharmaceuticals"). necessity to use unauthorized pharmaceuticals. the need for oxygen therapy at the time of screening. hospitalization required at time of screening, or hospitalization expected to be required for covid-19 within 48 hours of randomization, excluding hospitalization to the observation facility for social reasons (e. g., living in a hostel, cohabiting with people, including those with risk factors for aggravated covid-19, who, after contact with the patient, have a negative result for the sars-cov-2 rna/antigen, etc.). severe and extremely severe disease signs as of the time of screening. vaccination within less than 4 weeks prior to screening. possible or confirmed moderate covid-19 within 6 months prior to screening. possible or confirmed history of severe or very severe covid-19. patients with moderate to severe renal insufficiency (estimated glomerular filtration rate (gfr) < 60 ml/min/1.73 m2 per ckd-epi formula) or receiving renal replacement therapy at the time of screening. severe liver failure (class c per child-pugh) at the time of screening or elevated alt and/or ast levels of ≥ 2.5 unl and/or elevated total bilirubin levels of ≥ 2 unl (≥ 3 unl with gilbert's syndrome) in past medical history (within 6 months prior to screening). positive test result for hiv, syphilis, hepatitis b and/or c at the time of screening. alcohol, pharmacological and/or drug dependence (history and/or at the time of screening). schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening. any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the patient due to his/her participation in the study. unwillingness or inability of a patient to comply with the protocol procedures (in the opinion of the investigator). pregnant or lactating women, or women planning a pregnancy. participation in another clinical study within 3 months prior to enrolment in the present study. other conditions that prevent the patient from inclusion in the study.

hypersensitivity to the study drug components. lactase deficiency, lactose intolerance, glucose-galactose malabsorption. use of direct-acting antiviral drugs within 10 days prior to screening. the use of drugs at the time of screening whose clearance is highly dependent on the cyp3a isoenzyme, or which are strong inducers of cyp3a (for more information, see the section "unauthorized pharmaceuticals"). necessity to use unauthorized pharmaceuticals. the need for oxygen therapy at the time of screening. hospitalization required at time of screening, or hospitalization expected to be required for covid-19 within 48 hours of randomization, excluding hospitalization to the observation facility for social reasons (e. g., living in a hostel, cohabiting with people, including those with risk factors for aggravated covid-19, who, after contact with the patient, have a negative result for the sars-cov-2 rna/antigen, etc.). severe and extremely severe disease signs as of the time of screening. vaccination within less than 4 weeks prior to screening. possible or confirmed moderate covid-19 within 6 months prior to screening. possible or confirmed history of severe or very severe covid-19. patients with moderate to severe renal insufficiency (estimated glomerular filtration rate (gfr) < 60 ml/min/1.73 m2 per ckd-epi formula) or receiving renal replacement therapy at the time of screening. severe liver failure (class c per child-pugh) at the time of screening or elevated alt and/or ast levels of ≥ 2.5 unl and/or elevated total bilirubin levels of ≥ 2 unl (≥ 3 unl with gilbert's syndrome) in past medical history (within 6 months prior to screening). positive test result for hiv, syphilis, hepatitis b and/or c at the time of screening. alcohol, pharmacological and/or drug dependence (history and/or at the time of screening). schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening. any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the patient due to his/her participation in the study. unwillingness or inability of a patient to comply with the protocol procedures (in the opinion of the investigator). pregnant or lactating women, or women planning a pregnancy. participation in another clinical study within 3 months prior to enrolment in the present study. other conditions that prevent the patient from inclusion in the study.