Created at Source Raw Value Validated value
Oct. 26, 2020, 7:26 a.m. eu

1. Adult males and females ≥18 years and ≤80 years of age at the time of screening. 2. Are hospitalised during the screening period with duration of hospitalisation prior to randomisation ≤48 hours. 3. Have a diagnosis of COVID-19 based on symptoms onset and SARS-CoV-2 RT-PCR test positive from nasopharyngeal swab. 4. Have at least one (1) of the following: a. Radiographic pulmonary infiltrates (CT scan), AND/OR b. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, AND/OR c. Requirement of supplemental oxygen. 5. If female, of non-childbearing potential (e.g. post-menopausal as demonstrated by FSH or surgical sterilization i.e., tubal ligation or hysterectomy), or if of childbearing potential, be willing to commit to either sexual abstinence or use of at least 2 medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from screening through 7 months after last alisporivir dose. 6. If male, a willingness to refrain from donating sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation) from screening through 4 months after last alisporivir dose. 7. Willing and able to provide written informed consent. 8. Willing to comply with all study assessments and adhere to the protocol schedule. 9. Has an affiliation with a social security system.

1. Adult males and females ≥18 years and ≤80 years of age at the time of screening. 2. Are hospitalised during the screening period with duration of hospitalisation prior to randomisation ≤48 hours. 3. Have a diagnosis of COVID-19 based on symptoms onset and SARS-CoV-2 RT-PCR test positive from nasopharyngeal swab. 4. Have at least one (1) of the following: a. Radiographic pulmonary infiltrates (CT scan), AND/OR b. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, AND/OR c. Requirement of supplemental oxygen. 5. If female, of non-childbearing potential (e.g. post-menopausal as demonstrated by FSH or surgical sterilization i.e., tubal ligation or hysterectomy), or if of childbearing potential, be willing to commit to either sexual abstinence or use of at least 2 medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from screening through 7 months after last alisporivir dose. 6. If male, a willingness to refrain from donating sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation) from screening through 4 months after last alisporivir dose. 7. Willing and able to provide written informed consent. 8. Willing to comply with all study assessments and adhere to the protocol schedule. 9. Has an affiliation with a social security system.