Created at Source Raw Value Validated value
July 16, 2021, 11:30 p.m. eu

1. Written Informed Consent obtained and documented according to ICH/GCP and national/local regulations prior to any study-specific procedure. 2. Males and females aged ≥18-85 years at the time of signing the informed consent form. Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subject must be willing to use condoms with spermicide, and if he has a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subjects must also refrain from donating sperm from the first dose until three months after dosing with investigational product (IP). * Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomy, sexual abstinence. 3. Patients with symptoms and signs of SARS-CoV-2 infection according to WHO case definition. Symptoms must include shortness of breath, with an onset which occurred ≤ 10 days before admission, and the COVID-19 diagnosis must be confirmed by laboratory testing (PCR-positive). In addition, moderately impaired oxygenation as demonstrated by oxygen saturation ≤ 93% but ≥ 87% on room air, or requiring 1-5 L/min of oxygen to obtain an oxygen saturation of 92%, and at least one of the following laboratory values: A. Ferritin: > 300 ng/mL for men and > 150 ng/mL for women B. C-reactive protein (CRP): ≥ 10 mg/L C. D-dimer elevated above the age-adjusted lower limit: > 0.5 mg/L i. ≤ 50 years, < 0.5 mg/L FEU i.ii. > 50 years, age-related, calculated as follows: 0.5 mg/L FEU + 0.01 mg/L FEU for every year over 50 (i.e. one who is 70 years old has thus a reference limit of < 0.7 mg/L FEU, on who is 90 years old has a reference limit of < 0.9 mg/L FEU) 4. Able to swallow capsules. 5. Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.

1. Written Informed Consent obtained and documented according to ICH/GCP and national/local regulations prior to any study-specific procedure. 2. Males and females aged ≥18-85 years at the time of signing the informed consent form. Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subject must be willing to use condoms with spermicide, and if he has a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subjects must also refrain from donating sperm from the first dose until three months after dosing with investigational product (IP). * Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomy, sexual abstinence. 3. Patients with symptoms and signs of SARS-CoV-2 infection according to WHO case definition. Symptoms must include shortness of breath, with an onset which occurred ≤ 10 days before admission, and the COVID-19 diagnosis must be confirmed by laboratory testing (PCR-positive). In addition, moderately impaired oxygenation as demonstrated by oxygen saturation ≤ 93% but ≥ 87% on room air, or requiring 1-5 L/min of oxygen to obtain an oxygen saturation of 92%, and at least one of the following laboratory values: A. Ferritin: > 300 ng/mL for men and > 150 ng/mL for women B. C-reactive protein (CRP): ≥ 10 mg/L C. D-dimer elevated above the age-adjusted lower limit: > 0.5 mg/L i. ≤ 50 years, < 0.5 mg/L FEU i.ii. > 50 years, age-related, calculated as follows: 0.5 mg/L FEU + 0.01 mg/L FEU for every year over 50 (i.e. one who is 70 years old has thus a reference limit of < 0.7 mg/L FEU, on who is 90 years old has a reference limit of < 0.9 mg/L FEU) 4. Able to swallow capsules. 5. Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.

Feb. 2, 2021, 4:49 p.m. eu

1. Written Informed Consent obtained and documented according to ICH/GCP and national/local regulations prior to any study-specific procedure. 2. Males and females aged ≥18-75 years at the time of signing the informed consent form. Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subject must be willing to use condoms with spermicide, and if he has a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subjects must also refrain from donating sperm from the first dose until three months after dosing with investigational product (IP). * Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomy, sexual abstinence. 3. Patients with symptoms and signs of SARS-CoV-2 infection according to WHO case definition. Symptoms must include shortness of breath, with an onset which occurred ≤ 1 week before admission, and the COVID-19 diagnosis must be confirmed by laboratory testing (PCR-positive). In addition, moderately impaired oxygenation as demonstrated by oxygen saturation ≤ 93% but ≥ 87% on room air, or requiring 1-5 L/min of oxygen to obtain an oxygen saturation of 92%, and at least one of the following laboratory values: A. Ferritin: > 300 ng/mL for men and > 150 ng/mL for women B. C-reactive protein (CRP): ≥ 10 mg/L C. D-dimer elevated above the age-adjusted lower limit: > 0.5 mg/L i. ≤ 50 years, < 0.5 mg/L FEU i.ii. > 50 years, age-related, calculated as follows: 0.5 mg/L FEU + 0.01 mg/L FEU for every year over 50 (i.e. one who is 70 years old has thus a reference limit of < 0.7 mg/L FEU, on who is 90 years old has a reference limit of < 0.9 mg/L FEU) 4. Able to swallow capsules. 5. Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.

1. Written Informed Consent obtained and documented according to ICH/GCP and national/local regulations prior to any study-specific procedure. 2. Males and females aged ≥18-75 years at the time of signing the informed consent form. Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subject must be willing to use condoms with spermicide, and if he has a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subjects must also refrain from donating sperm from the first dose until three months after dosing with investigational product (IP). * Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomy, sexual abstinence. 3. Patients with symptoms and signs of SARS-CoV-2 infection according to WHO case definition. Symptoms must include shortness of breath, with an onset which occurred ≤ 1 week before admission, and the COVID-19 diagnosis must be confirmed by laboratory testing (PCR-positive). In addition, moderately impaired oxygenation as demonstrated by oxygen saturation ≤ 93% but ≥ 87% on room air, or requiring 1-5 L/min of oxygen to obtain an oxygen saturation of 92%, and at least one of the following laboratory values: A. Ferritin: > 300 ng/mL for men and > 150 ng/mL for women B. C-reactive protein (CRP): ≥ 10 mg/L C. D-dimer elevated above the age-adjusted lower limit: > 0.5 mg/L i. ≤ 50 years, < 0.5 mg/L FEU i.ii. > 50 years, age-related, calculated as follows: 0.5 mg/L FEU + 0.01 mg/L FEU for every year over 50 (i.e. one who is 70 years old has thus a reference limit of < 0.7 mg/L FEU, on who is 90 years old has a reference limit of < 0.9 mg/L FEU) 4. Able to swallow capsules. 5. Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.