NCT04452435

Safety and Efficacy of C21 in Subjects With COVID-19

A Randomised, Double-blind, Placebo-controlled, Phase 2 Trial Investigating the Safety and Efficacy of C21 in Hospitalised Subjects With COVID-19 Infection Not Requiring Mechanical Ventilation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Vicore Pharma AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blind, placebo-controlled phase 2 trial investigating the safety and efficacy of C21 in subjects who are hospitalised with COVID-19 infection, but not in need of mechanical invasive or non-invasive ventilation. In total, approximately 100 subjects will be enrolled and randomised to receive twice daily oral administration of either standard of care (SoC) + placebo (N=50) or SoC + C21 (N=50). Subjects will be treated for 7 days.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	C21	C21
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-07-21
• Primary completion: 2020-10-13
• Completion: 2020-10-13
• First posted: 2020-06-30
• Last updated: 2021-06-23
• Results posted: 2021-04-30

Locations

9 sites across 2 countries: India, United Kingdom