Created at Source Raw Value Validated value
April 22, 2022, 4:30 a.m. eu

1. The patient must be willing and able to give informed consent to participate in the study and to adhere to the procedures stated in the protocol or, for adults incapable of consenting due to their medical condition (eg, too weak or debilitated, severe shortness of breath) or due to literacy issues, the patient’s legally authorized representative must be willing and able to give informed consent on behalf of the patient to participate in the study as permitted by local regulatory authorities, institutional review boards (IRBs)/independent ethics committees (IECs), or local laws, 2. The patient is male or female adult aged ≥18 years (as per local laws) at the time of giving informed consent, 3. The patient is admitted to a hospital and has a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test. Please note: If the patient has a previous confirmation of SARS-CoV-2 (within 7 days of Day 1), the SARS-CoV-2 test at screening is not required, 4. The patient has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19 on Day 1, such as presence of fever (≥38.0°C [≥100.4°F] by any route), loss of smell or taste, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath upon exertion and/or at rest, or respiratory distress, 5. The patient has the presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID-19 on Day 1: a) Moderate: i. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥20 breaths per minute, SpO2 >93% (on room air at sea level, if possible), heart rate ≥90 beats per minute ii. No clinical signs indicative of severe or critical COVID-19 b) Severe: i. Clinical signs suggestive of severe systemic illness with COVID-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% (on room air at sea level, if possible), partial pressure of oxygen/FiO2 <300, or diagnosed with acute respiratory distress syndrome (according to the Berlin definition) ii. No criteria met for critical COVID-19 6. The patient does not require hemodialysis (chronic) or any renal replacement therapies at screening or Day 1, 7. The patient is able to swallow the study drug (hard gelatin capsules), 8. The patient agrees to minimize strong sun exposure (sunbathing) and strong ultraviolet exposure during the course of the study. Additionally, during the study, patients must agree to use sunscreen when spending an extended period outdoors, 9. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: a) Vasectomy with documentation of azoospermia. b) Sexual abstinence (defined as refraining from heterosexual intercourse from the time of first dose of study medication until at least 30 days after the last dose of study medication) c) Male condom plus partner use of 1 of the contraceptive options below: contraceptive subdermal implant, intrauterine device or intrauterine system, oral contraceptive, either combined or progestogen alone, injectable progestogen, contraceptive vaginal ring, percutaneous contraceptive patches. 10. WOCBP must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: a) Sexual abstinence (defined as refraining from heterosexual intercourse from the time of first dose of study medication until at least 30 days after the last dose of study medication) b) Use of 1 of the contraceptive options below plus use of a condom by male partner: contraceptive subdermal implant, intrauterine device or intrauterine system, oral contraceptive, either combined or progestogen alone, injectable progestogen, contraceptive vaginal ring, percutaneous contraceptive patches. c) Vasectomy of male partner with documentation of azoospermia.

1. The patient must be willing and able to give informed consent to participate in the study and to adhere to the procedures stated in the protocol or, for adults incapable of consenting due to their medical condition (eg, too weak or debilitated, severe shortness of breath) or due to literacy issues, the patient’s legally authorized representative must be willing and able to give informed consent on behalf of the patient to participate in the study as permitted by local regulatory authorities, institutional review boards (IRBs)/independent ethics committees (IECs), or local laws, 2. The patient is male or female adult aged ≥18 years (as per local laws) at the time of giving informed consent, 3. The patient is admitted to a hospital and has a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test. Please note: If the patient has a previous confirmation of SARS-CoV-2 (within 7 days of Day 1), the SARS-CoV-2 test at screening is not required, 4. The patient has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19 on Day 1, such as presence of fever (≥38.0°C [≥100.4°F] by any route), loss of smell or taste, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath upon exertion and/or at rest, or respiratory distress, 5. The patient has the presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID-19 on Day 1: a) Moderate: i. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥20 breaths per minute, SpO2 >93% (on room air at sea level, if possible), heart rate ≥90 beats per minute ii. No clinical signs indicative of severe or critical COVID-19 b) Severe: i. Clinical signs suggestive of severe systemic illness with COVID-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% (on room air at sea level, if possible), partial pressure of oxygen/FiO2 <300, or diagnosed with acute respiratory distress syndrome (according to the Berlin definition) ii. No criteria met for critical COVID-19 6. The patient does not require hemodialysis (chronic) or any renal replacement therapies at screening or Day 1, 7. The patient is able to swallow the study drug (hard gelatin capsules), 8. The patient agrees to minimize strong sun exposure (sunbathing) and strong ultraviolet exposure during the course of the study. Additionally, during the study, patients must agree to use sunscreen when spending an extended period outdoors, 9. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: a) Vasectomy with documentation of azoospermia. b) Sexual abstinence (defined as refraining from heterosexual intercourse from the time of first dose of study medication until at least 30 days after the last dose of study medication) c) Male condom plus partner use of 1 of the contraceptive options below: contraceptive subdermal implant, intrauterine device or intrauterine system, oral contraceptive, either combined or progestogen alone, injectable progestogen, contraceptive vaginal ring, percutaneous contraceptive patches. 10. WOCBP must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: a) Sexual abstinence (defined as refraining from heterosexual intercourse from the time of first dose of study medication until at least 30 days after the last dose of study medication) b) Use of 1 of the contraceptive options below plus use of a condom by male partner: contraceptive subdermal implant, intrauterine device or intrauterine system, oral contraceptive, either combined or progestogen alone, injectable progestogen, contraceptive vaginal ring, percutaneous contraceptive patches. c) Vasectomy of male partner with documentation of azoospermia.