Created at Source Raw Value Validated value
Oct. 26, 2020, 7:26 a.m. eu

- Active COVID-19 as defined by clinical WHO criteria and a positive PCR for SARS-COV2 - Use of any investigational agent within 28 days prior to study start - Ongoing radiotherapy - A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs - Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >450ms). - Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) - Inadequate kidney function: serum-creatinine >2.0 times upper normal limit - Hepatic dysfunction: total bilirubin >1.5 times upper normal limit (unless due cancer involvement of liver or a known history of Gilbert's disease), ALT >2.5 times upper normal limit (unless due to disease involvement of liver), alkaline phosphatase >2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow) - Patients with active opportunistic infections - Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days of administration of IMP. Approved methods of birth control must be used - Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. - Inability to swallow tablets/study medication

- Active COVID-19 as defined by clinical WHO criteria and a positive PCR for SARS-COV2 - Use of any investigational agent within 28 days prior to study start - Ongoing radiotherapy - A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs - Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >450ms). - Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) - Inadequate kidney function: serum-creatinine >2.0 times upper normal limit - Hepatic dysfunction: total bilirubin >1.5 times upper normal limit (unless due cancer involvement of liver or a known history of Gilbert's disease), ALT >2.5 times upper normal limit (unless due to disease involvement of liver), alkaline phosphatase >2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow) - Patients with active opportunistic infections - Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days of administration of IMP. Approved methods of birth control must be used - Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. - Inability to swallow tablets/study medication