Created at Source Raw Value Validated value
Nov. 6, 2020, 12:30 a.m. eu

Patients infected with SARS-CoV-2 virus and 1. age ≥ 18 years and ≤ 75 years 2. fulfills RKI case definition including a positive verification of a SARS-CoV-2 infection from any specimen (e.g. respiratory, blood, other bodily fluid)* * confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) 3. mild disease defined by the following criteria: - Hospitalized (score 3 or 4 of WHO R&D Blueprint ordinal scale for clinical improvement) 4. signed written informed consent and willingness to comply with treatment and follow-up procedures 5. ► men, or ► women without childbearing potential defined as follows: at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy, hysterectomy or uterine agenesis, ≥ 50 years and in postmenopausal state > 1 year, or < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening, or ► women with childbearing potential: who are practicing true abstinence from sexual intercourse (periodic abstinence and withdrawal are not acceptable), who have sexual relationship with female partners only and/or with sterile male partners, or who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial.

Patients infected with SARS-CoV-2 virus and 1. age ≥ 18 years and ≤ 75 years 2. fulfills RKI case definition including a positive verification of a SARS-CoV-2 infection from any specimen (e.g. respiratory, blood, other bodily fluid)* * confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) 3. mild disease defined by the following criteria: - Hospitalized (score 3 or 4 of WHO R&D Blueprint ordinal scale for clinical improvement) 4. signed written informed consent and willingness to comply with treatment and follow-up procedures 5. ► men, or ► women without childbearing potential defined as follows: at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy, hysterectomy or uterine agenesis, ≥ 50 years and in postmenopausal state > 1 year, or < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening, or ► women with childbearing potential: who are practicing true abstinence from sexual intercourse (periodic abstinence and withdrawal are not acceptable), who have sexual relationship with female partners only and/or with sterile male partners, or who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial.