Created at Source Raw Value Validated value
June 2, 2022, 8 a.m. oms

1. Age =18 years and =79 years at the time of obtaining informed consent 2. Participants must: 2.1. Have positive SARS-CoV-2 result (any validated test, e.g. RT-PCR [performed on an appropriate specimen, e.g. respiratory tract sample]) 2.2. AND be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19) 2.3. AND be developing new-onset of oxygenation impairment requiring any of the following: 2.3.1. High-flow oxygen (=15 l/min) 2.3.2. Non-invasive ventilation (e.g. CPAP, BiPAP) 2.3.3. Mechanical ventilation =48 h prior to dose 2.4. AND have increased biological markers of systemic inflammation (either CRP >ULN1 or serum ferritin >ULN1). 3. No gender restriction. 4. Female participants must meet and agree to abide by the contraceptive criteria Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 4.1. Is a woman of non-childbearing potential (WONCBP) OR 4.2. Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, during the study intervention period and for at least 60 days after the last dose of study intervention (sexual abstinence is acceptable if it is the participant’s normal practice). 4.3. If not consistently on a highly effective method of contraception during hospitalization, the participant must agree to a highly effective contraception plan if discharged before Day 60. 4.4. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relation to the first dose of study intervention. 4.5. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at hospital admission or before the first dose of study intervention. 4.6. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. 5. Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures will be followed as detailed in the protocol

1. Age =18 years and =79 years at the time of obtaining informed consent 2. Participants must: 2.1. Have positive SARS-CoV-2 result (any validated test, e.g. RT-PCR [performed on an appropriate specimen, e.g. respiratory tract sample]) 2.2. AND be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19) 2.3. AND be developing new-onset of oxygenation impairment requiring any of the following: 2.3.1. High-flow oxygen (=15 l/min) 2.3.2. Non-invasive ventilation (e.g. CPAP, BiPAP) 2.3.3. Mechanical ventilation =48 h prior to dose 2.4. AND have increased biological markers of systemic inflammation (either CRP >ULN1 or serum ferritin >ULN1). 3. No gender restriction. 4. Female participants must meet and agree to abide by the contraceptive criteria Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 4.1. Is a woman of non-childbearing potential (WONCBP) OR 4.2. Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, during the study intervention period and for at least 60 days after the last dose of study intervention (sexual abstinence is acceptable if it is the participant’s normal practice). 4.3. If not consistently on a highly effective method of contraception during hospitalization, the participant must agree to a highly effective contraception plan if discharged before Day 60. 4.4. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relation to the first dose of study intervention. 4.5. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at hospital admission or before the first dose of study intervention. 4.6. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. 5. Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures will be followed as detailed in the protocol