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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Placebo; Drug: C21

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmadabad, Gujarat, India, 380016
      • Department of Medicine, Civil Hospital and B J Medical College
    • Surat, Gujarat, India, 395001
      • Infectious Disease, Metas Adventist Hospital
    • Surat, Gujarat, India, 395010
      • Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
    • Vadodara, Gujarat, India, 290022
      • First Floor Clinical Research Department Rhythm Heart Institute
  • Maharashtra
    • Mumbai, Maharashtra, India, 400016
      • Internal Medicine S.L. Raheja Hospital
    • Nagpur, Maharashtra, India, 440003
      • Department of Medicine, Government Medical College and Hospital
    • Pune, Maharashtra, India, 411001
      • Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic
    • Pune, Maharashtra, India
      • Department of Medicine, Noble Hospitals Pvt. Ltd
• United Kingdom
  • London, United Kingdom, WC1E 6BT
    • Respiratory Medicine, University College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C21 100 mg twice daily; Oral C21 treatment 100 mg twice daily for 7 days	Drug: C21; C21
Placebo Comparator: Placebo; Oral placebo treatment 100 mg twice daily for 7 days	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Body Temperature	Change in body temperature from baseline to the average of the last two assessments in the treatment period	Treatment period of 7 days ((Day 1 to Day 8)
Change From Baseline in IL-6	Change in IL-6 from baseline to the average of the last two assessments during the treatment period	Treatment period of 7 days (Day 1 to Day 8)
Change From Baseline in IL-10	Change in IL-10 from baseline to the average of the last two assessments during the treatment period	Treatment period of 7 days (Day 1 to Day 8)
Change From Baseline in TNF	Change in TNF from baseline to the average of the last two assessments during the treatment period.	Treatment period of 7 days (Day 1 to Day 8)
Change From Baseline in CA125	Change in CA125 from baseline to the average of the last two assessments in the treatment period	Treatment period of 7 days (Day 1 to Day 8)
Change From Baseline in Ferritin	Change in Ferritin from baseline to the average of the last two assessments during the treatment period.	Treatment period of 7 days (Day 1 to Day 8)
Number of Subjects Not in Need of Oxygen Supply	Number of subjects not in need of oxygen supply at the end of treatment	End-of treatment, Day 7 or 8
Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation	Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period	Treatment period of 7 days (Day 1 to Day 8)
Time to Need of Mechanical Invasive or Non-invasive Ventilation	Time to need of mechanical invasive or non-invasive ventilation during treatment period	Treatment period of 7 days
Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)	Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation)	Treatment period of 7 days (Day 1 to Day 8)
Adverse Events	Adverse events were reported from signing of informed consent until end-of-trial visit. No AEs were reported from signing of informed consent until randomization, except for 2 fatal SAEs described under Adverse events.	Day 1 to end-of-trial (Visit 9)

Collaborators and Investigators

• Sponsor: Vicore Pharma AB
• Collaborators: Orphan Reach
• Investigators: Principal Investigator: Joanna Porter, MD, Respiratory Medicine, University College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): October 13, 2020
• Study Completion (Actual): October 13, 2020

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: VP-C21-006; 2020-001502-38 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No