NCT04880642

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3, Multicenter Trial Investigating the Efficacy and Safety of C21 as add-on to Standard of Care in Adult Subjects With COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Vicore Pharma AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The trial consists of 3 consecutive periods: a screening period of up to 48 hours, a 2-week investigational medicinal product (IMP) treatment period and a follow-up period of up to 7 weeks after last IMP intake. All subjects went through a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and samples for future exploratory analysis were obtained at the screening visit. The trial duration for an individual subject was not exceeded 9 weeks.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	C21	C21
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-09-16
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2021-05-11
• Last updated: 2023-12-14
• Results posted: 2023-12-14

Locations

60 sites across 10 countries: United States, Argentina, Brazil, Colombia, Czechia, India, Philippines, Russia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study