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

he participant may enter the study if the following apply: 1. Adult participants: Signed informed consent 2. New admission to hospital for period expected to last ≥ 1 night 3. Suspected or confirmed COVID-19 infection Patients are suspected of COVID-19 infection if they have one of the following: · Influenza like illness (fever ≥37.8°C and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing). · Acute respiratory distress syndrome · Radiological evidence of pneumonia 4. For women to be eligible to enter and participate in the study they should be: of non-child-bearing - potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, - or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of < 1% per year as indicated in Appendix B during the treatment and for a period of 7 days after the last dose. Hormonal contraceptive methods must be supplemented by a barrier method. 5. Men who are sexually active must use an adequate method of contraception as listed in Appendix B, for a period of at least 7 days after the last dose

he participant may enter the study if the following apply: 1. Adult participants: Signed informed consent 2. New admission to hospital for period expected to last ≥ 1 night 3. Suspected or confirmed COVID-19 infection Patients are suspected of COVID-19 infection if they have one of the following: · Influenza like illness (fever ≥37.8°C and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing). · Acute respiratory distress syndrome · Radiological evidence of pneumonia 4. For women to be eligible to enter and participate in the study they should be: of non-child-bearing - potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, - or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of < 1% per year as indicated in Appendix B during the treatment and for a period of 7 days after the last dose. Hormonal contraceptive methods must be supplemented by a barrier method. 5. Men who are sexually active must use an adequate method of contraception as listed in Appendix B, for a period of at least 7 days after the last dose