Created at Source Raw Value Validated value
Jan. 27, 2021, 1:30 a.m. eu

1. Willing and able to provide written informed consent prior to performing study procedures 2. SARS-CoV-2 positivity of the nasal-/throat-swab/saliva swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory ≤ 4 days before randomization 3. Moderate severity of COVID -19 (See Appendix 2, FDA severity categorization) 4. Currently hospitalized or requiring hospitalization for the COVID-19 medical care 5. Age >18 and <85 years 6. Presence of at least 3 of the following symptoms as present: fever, cough, myalgia, fatigue 7. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93%, heart rate ≥ 90 beats per minute ≤ 2 days before screening 8. Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential. Acceptable methods of birth control include: spermicide with barrier, oral, transdermal, injectable, or implantable contraception, IUD, abstinence, and surgical sterilization of partner. Female subjects are not of childbearing potential if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or are post-menopausal by at least 12 months.

1. Willing and able to provide written informed consent prior to performing study procedures 2. SARS-CoV-2 positivity of the nasal-/throat-swab/saliva swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory ≤ 4 days before randomization 3. Moderate severity of COVID -19 (See Appendix 2, FDA severity categorization) 4. Currently hospitalized or requiring hospitalization for the COVID-19 medical care 5. Age >18 and <85 years 6. Presence of at least 3 of the following symptoms as present: fever, cough, myalgia, fatigue 7. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93%, heart rate ≥ 90 beats per minute ≤ 2 days before screening 8. Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential. Acceptable methods of birth control include: spermicide with barrier, oral, transdermal, injectable, or implantable contraception, IUD, abstinence, and surgical sterilization of partner. Female subjects are not of childbearing potential if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or are post-menopausal by at least 12 months.