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Safety and Efficacy of C21 in Subjects With COVID-19

NCT04452435 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2021-06-23

Study results available
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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

Interventions

DRUG

C21

C21

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Orphan Reach Ltd.

    collaborator INDUSTRY

  • Vicore Pharma AB

    lead INDUSTRY

Principal Investigators

  • Joanna Porter, MD · Respiratory Medicine, University College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2020-10-13
Completion
2020-10-13

Countries

  • India
  • United Kingdom

Study Locations

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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 NCT04452435 on ClinicalTrials.gov