The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design. This early end of trial is not due to reasons of safety or lack of efficacy. Part 1 (Phase 1) is completed as per protocol.

This is a 2 part study where the first part (Phase 1) evaluates the safety of XVR011 and aims to identify the recommended Phase 2 dose. The second part (Phase 2) follows after the part 1 and evaluates whether XVR011 added to standard of care in patients hospitalised for mild to moderate COVID-19 is a safe, well tolerated, and effective treatment.

Part 1 (Phase 1) is completed as per protocol. The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design.

Inclusion Criteria:

• Is ≥ 18 years of age.
• Tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by RT-PCR and/or antigen test.
• Had an onset of COVID-19 symptom(s) within 8 days prior to screening; except for dyspnoea and/or tachypnoea for which an onset within 2 days prior to screening is applicable.
• Requires hospitalisation for medical care.
• Has oxygen saturation >= 91%.

Exclusion Criteria:

• Requires non-invasive or invasive mechanical ventilation and/or intensive care.
• Symptoms consistent with severe COVID-19.
• Has received a monoclonal antibody, plasma from a person who recovered from COVID-19 or any investigational treatment for COVID-19 within 30 days prior to study treatment.
• Has received an investigational or approved vaccination against SARS-CoV-2 within 14 days prior to study treatment.

NOTE: Other protocol defined inclusion/exclusion criteria apply