1. Capable of giving signed informed consent as described in Section 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Study participant must be at least 18 years of age at the time of signing the ICF. 3. Study participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection presenting as moderate -to-severe COVID-19 requiring hospitalization for COVID-19 (Clinical Severity Status [3] or [4]) and for medical reasons (see Section 8 of the protocol). Patients presenting to the hospital without a laboratory confirmed SARS-CoV-2 infection will be tested locally for SARS-CoV-2 during the screening period. For sites in the EU: A CE certified SARS-CoV-2 PCR test kit is required to confirm infection. For sites outside the EU: SARS-CoV-2 PCR test kits certified according to local regulations are required to confirm infection. 4. Body weight at least 50 kg and have a body mass index (BMI) ≥ 18.0 kg/m2 and < 40.0 kg/m2. 5. Male or female. 6. A female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a. She is not a WOCBP as defined in Section 10.3.1 of the protocol. b. Is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 4 weeks after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP. 7. A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of IMP, see Section 8.3.5 of the protocol. a. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive. b. If a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive. c. 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 undetectable pregnancy. 8. A male study participant is eligible to participate if: a. He is azoospermic b. The partner is not a WOCBP as defined in Section 1.1.1 of the protocol. c. The partner is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 90 days after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP. d. He acknowledges that sperm donation is prohibited from the first dose of IMP until at least 90 days after the last dose of IMP.

1. Capable of giving signed informed consent as described in Section 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Study participant must be at least 18 years of age at the time of signing the ICF. 3. Study participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection presenting as moderate -to-severe COVID-19 requiring hospitalization for COVID-19 (Clinical Severity Status [3] or [4]) and for medical reasons (see Section 8 of the protocol). Patients presenting to the hospital without a laboratory confirmed SARS-CoV-2 infection will be tested locally for SARS-CoV-2 during the screening period. For sites in the EU: A CE certified SARS-CoV-2 PCR test kit is required to confirm infection. For sites outside the EU: SARS-CoV-2 PCR test kits certified according to local regulations are required to confirm infection. 4. Body weight at least 50 kg and have a body mass index (BMI) ≥ 18.0 kg/m2 and < 40.0 kg/m2. 5. Male or female. 6. A female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a. She is not a WOCBP as defined in Section 10.3.1 of the protocol. b. Is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 4 weeks after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP. 7. A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of IMP, see Section 8.3.5 of the protocol. a. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive. b. If a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive. c. 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 undetectable pregnancy. 8. A male study participant is eligible to participate if: a. He is azoospermic b. The partner is not a WOCBP as defined in Section 1.1.1 of the protocol. c. The partner is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 90 days after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP. d. He acknowledges that sperm donation is prohibited from the first dose of IMP until at least 90 days after the last dose of IMP.