Safety and Efficacy of C21 in Subjects With COVID-19

NCT ID: NCT04452435

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-21
• Study Completion Date: 2020-10-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

C21 100 mg twice daily

Oral C21 treatment 100 mg twice daily for 7 days

Group Type: EXPERIMENTAL

C21

Intervention Type: DRUG

C21

Placebo

Oral placebo treatment 100 mg twice daily for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

C21

C21

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure

2. Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test < 4 days before Visit 1 with signs of an acute respiratory infection

3. Age > 18 and < 70 years

4. CRP > 50 and < 150 mg/l

5. Admitted to a hospital or controlled facility (home quarantine is not sufficient)

6. In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol

Exclusion Criteria

1. Any previous experimental treatment for COVID-19

2. Need for mechanical invasive or non-invasive ventilation

3. Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis

4. Participation in any other interventional trial within 3 months prior to Visit 1

5. Any of the following findings at Visit 1:

• Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab
• Positive pregnancy test (see Section 8.2.3)

6. Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator

7. Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial

8. Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I

9. Treatment with any of the medications listed below within 1 week prior to Visit 1:

1. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John's Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbiturates)

2. Warfarin

10. Pregnant or breast-feeding female subjects

11. Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1

12. Male subjects not willing to use contraceptive methods as described in Section 5.3.1

13. Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orphan Reach Ltd.

INDUSTRY

Sponsor Role: collaborator

Vicore Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Porter, MD

Role: PRINCIPAL_INVESTIGATOR

Respiratory Medicine, University College Hospital

Locations

Department of Medicine, Civil Hospital and B J Medical College

Ahmedabad, Gujarat, India

Infectious Disease, Metas Adventist Hospital

Surat, Gujarat, India

Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital

Surat, Gujarat, India

First Floor Clinical Research Department Rhythm Heart Institute

Vadodara, Gujarat, India

Internal Medicine S.L. Raheja Hospital

Mumbai, Maharashtra, India

Department of Medicine, Government Medical College and Hospital

Nagpur, Maharashtra, India

Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, India

Department of Medicine, Noble Hospitals Pvt. Ltd

Pune, Maharashtra, India

Respiratory Medicine, University College Hospital

London, , United Kingdom

Countries

India; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan

View Document

Other Identifiers

2020-001502-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VP-C21-006

Identifier Type: -

Identifier Source: org_study_id