Safety and Efficacy of C21 in Subjects With COVID-19

NCT04452435 | Completed Phase 2 Results

• 2 other identifiers: VP-C21-0062020-001502-38
• Study Type: interventional
• Target: 206
• Locations: 2 countries
• Sites: 9

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

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)

  Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period

  Treatment period of 7 days (Day 1 to Day 8)

Secondary Outcomes (11)

• Change From Baseline in Body Temperature

  Treatment period of 7 days ((Day 1 to Day 8)

• Change From Baseline in IL-6

  Treatment period of 7 days (Day 1 to Day 8)

• Change From Baseline in IL-10

  Treatment period of 7 days (Day 1 to Day 8)

• Change From Baseline in TNF

  Treatment period of 7 days (Day 1 to Day 8)

• Change From Baseline in CA125

  Treatment period of 7 days (Day 1 to Day 8)

Study Arms (2)

C21 100 mg twice daily

EXPERIMENTAL

Oral C21 treatment 100 mg twice daily for 7 days

Drug: C21

Placebo

PLACEBO COMPARATOR

Oral placebo treatment 100 mg twice daily for 7 days

Drug: Placebo

Interventions

C21 DRUG

C21

C21 100 mg twice daily

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure
• 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
• Age \> 18 and \< 70 years
• CRP \> 50 and \< 150 mg/l
• Admitted to a hospital or controlled facility (home quarantine is not sufficient)
• In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol

You may not qualify if:

• Any previous experimental treatment for COVID-19
• Need for mechanical invasive or non-invasive ventilation
• 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
• Participation in any other interventional trial within 3 months prior to Visit 1
• 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)
• 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
• 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
• Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
• Treatment with any of the medications listed below within 1 week prior to Visit 1:
• Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John's Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbiturates)
• Warfarin
• Pregnant or breast-feeding female subjects
• Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1

Sponsors & Collaborators

• Vicore Pharma AB: lead
• Orphan Reach Ltd.: collaborator

Study Sites (9)

Department of Medicine, Civil Hospital and B J Medical College

Ahmedabad, Gujarat, 380016, India

Location

Infectious Disease, Metas Adventist Hospital

Surat, Gujarat, 395001, India

Location

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

Surat, Gujarat, 395010, India

Location

First Floor Clinical Research Department Rhythm Heart Institute

Vadodara, Gujarat, 290022, India

Location

Internal Medicine S.L. Raheja Hospital

Mumbai, Maharashtra, 400016, India

Location

Department of Medicine, Government Medical College and Hospital

Nagpur, Maharashtra, 440003, India

Location

Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Department of Medicine, Noble Hospitals Pvt. Ltd

Pune, Maharashtra, India

Location

Respiratory Medicine, University College Hospital

London, WC1E 6BT, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

compound 21

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Carl-Johan Dalsgaard
• Organization: Vicore Pharma

carl-johan.dalsgaard@vicorepharma.com

+46 70 975 98 63

Study Officials

• Joanna Porter, MD

  Respiratory Medicine, University College Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: June 30, 2020
• Study Start: July 21, 2020
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: June 23, 2021
• Results First Posted: April 30, 2021

Record last verified: 2021-06

Locations

IN (8); GB (1)