Created at Source Raw Value Validated value
June 9, 2021, 1:30 a.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.

Feb. 12, 2021, 1:30 a.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.

Nov. 27, 2020, 1:30 a.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.

Oct. 26, 2020, 7:26 a.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 of non-childbearing potential* (verbally confirmed) aged ≥18-75 years at the time of signing the informed consent form. (*defined as pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy, or as post-menopausal females defined as 12 months of amenorrhoea.) 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 or receive delivery of emptied capsule via a nasogastric (NG) or enteral feeding tube. 5. 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* and drug exposure of a partner. 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 occlasion, vasectomy, sexual abstinence 6. 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 of non-childbearing potential* (verbally confirmed) aged ≥18-75 years at the time of signing the informed consent form. (*defined as pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy, or as post-menopausal females defined as 12 months of amenorrhoea.) 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 or receive delivery of emptied capsule via a nasogastric (NG) or enteral feeding tube. 5. 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* and drug exposure of a partner. 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 occlasion, vasectomy, sexual abstinence 6. Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.