Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ExeVir Bio BV

Criteria

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 7 days prior to screening.

• Requires hospitalisation for medical care of mild to moderate symptoms and has oxygen saturation > 93%

Exclusion Criteria:

• Requires non-invasive or invasive mechanical ventilation and/or intensive care.

• Symptoms consistent with severe COVID-19

• Has received a SARS-CoV-2 vaccine, 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.

NOTE: Other protocol defined inclusion/exclusion criteria apply