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

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. 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.

Timeline

Start

2021-08-26

Primary completion

2022-03-18

Completion

2022-03-18

Outcome

Outcome not reported

Stopped (Business): “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.”

Drugs

Indications