Safety and Efficacy of C21 in Subjects With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452435
• Other study ID #: VP-C21-006
• Secondary ID: 2020-001502-38
• Status: Completed
• Phase: Phase 2
• Start date: July 21, 2020
• Est. completion date: October 13, 2020

Study information

• Verified date: June 2021
• Source: Vicore Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 13, 2020
• Est. primary completion date: October 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• C21
C21
• Placebo
Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Vicore Pharma AB	Orphan Reach

Countries where clinical trial is conducted

India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)