Safety and Efficacy of C21 in Subjects With COVID-19

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: C21; Drug: Placebo

• Registration Number: NCT04452435
• Lead Sponsor: Vicore Pharma AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-06-30
• Study Start: 2020-07-21
• Primary Completion: 2020-10-13
• Study Completion: 2020-10-13
• Results First Submitted: 2021-03-24
• Results First Submitted QC: 2021-04-28
• Results First Posted: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C21 100 mg twice daily	C21	Oral C21 treatment 100 mg twice daily for 7 days
Placebo	Placebo	Oral placebo treatment 100 mg twice daily for 7 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)	Treatment period of 7 days (Day 1 to Day 8)	Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Temperature	Treatment period of 7 days ((Day 1 to Day 8)	Change in body temperature from baseline to the average of the last two assessments in the treatment period
Change From Baseline in IL-10	Treatment period of 7 days (Day 1 to Day 8)	Change in IL-10 from baseline to the average of the last two assessments during the treatment period
Time to Need of Mechanical Invasive or Non-invasive Ventilation	Treatment period of 7 days	Time to need of mechanical invasive or non-invasive ventilation during treatment period
Change From Baseline in IL-6	Treatment period of 7 days (Day 1 to Day 8)	Change in IL-6 from baseline to the average of the last two assessments during the treatment period
Change From Baseline in TNF	Treatment period of 7 days (Day 1 to Day 8)	Change in TNF from baseline to the average of the last two assessments during the treatment period.
Change From Baseline in CA125	Treatment period of 7 days (Day 1 to Day 8)	Change in CA125 from baseline to the average of the last two assessments in the treatment period
Change From Baseline in Ferritin	Treatment period of 7 days (Day 1 to Day 8)	Change in Ferritin from baseline to the average of the last two assessments during the treatment period.
Number of Subjects Not in Need of Oxygen Supply	End-of treatment, Day 7 or 8	Number of subjects not in need of oxygen supply at the end of treatment
Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)	Treatment period of 7 days (Day 1 to Day 8)	Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation)
Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation	Treatment period of 7 days (Day 1 to Day 8)	Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period
Adverse Events	Day 1 to end-of-trial (Visit 9)	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.

Trial Locations

Locations (9)

Department of Medicine, Civil Hospital and B J Medical College; 🇮🇳 Ahmadabad, Gujarat, India

First Floor Clinical Research Department Rhythm Heart Institute; 🇮🇳 Vadodara, Gujarat, India

Infectious Disease, Metas Adventist Hospital; 🇮🇳 Surat, Gujarat, India

Internal Medicine S.L. Raheja Hospital; 🇮🇳 Mumbai, Maharashtra, India

Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital; 🇮🇳 Surat, Gujarat, India

Department of Medicine, Noble Hospitals Pvt. Ltd; 🇮🇳 Pune, 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

Respiratory Medicine, University College Hospital; 🇬🇧 London, United Kingdom