A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects

Summary

This trial is a randomized, double-blind, placebo-controlled, parallel-group, 2-arm, multicenter trial to evaluate the efficacy and safety of C21 versus placebo as add-on to standard of care (SoC) in adult subjects with COVID-19. The trial planned to enroll a total of maximum 300 randomized subjects, 150 per arm (oral C21 100 mg twice a day (BID) or placebo for 14 days) according to the 1:1 randomization.

Timeline

Start

2021-09-16

Primary completion

2022-04-25

Completion

2022-04-25

Outcome

Missed primary endpoint

registry analysis (superiority test); C21 Treatment vs Placebo Treatment; p = 0.949; Hazard Ratio (HR) 0.98 (95% CI 0.40 to 2.36); Log Rank NCT04880642 ↗

Drugs

Indications