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

NCT04880642 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2023-12-14

Study results available
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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.

Conditions

Interventions

DRUG

C21

C21

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Vicore Pharma AB

    lead INDUSTRY

Principal Investigators

  • Maureen Horton, MD · Johns Hopkins University School of Medicine, Baltimore, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2022-04-25
Completion
2022-04-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Colombia
  • Czechia
  • India
  • Philippines
  • Russia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880642 on ClinicalTrials.gov