Safety and Efficacy of C21 in Subjects With COVID-19

• ClinicalTrials.gov Identifier: NCT04452435
• Recruitment Status: Completed
• First Posted: June 30, 2020
• Results First Posted: April 30, 2021
• Last Update Posted: June 23, 2021
• Sponsor: Vicore Pharma AB
• Collaborator: Orphan Reach
• Information provided by (Responsible Party): Vicore Pharma AB

Tracking Information

• First Submitted Date: June 29, 2020
• First Posted Date: June 30, 2020
• Results First Submitted Date: March 24, 2021
• Results First Posted Date: April 30, 2021
• Last Update Posted Date: June 23, 2021
• Actual Study Start Date: July 21, 2020
• Actual Primary Completion Date: October 13, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2021)

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

Original Primary Outcome Measures (submitted: June 29, 2020)

Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.) [ Time Frame: Treatment period of 7 days ]

Primary endpoint

Current Secondary Outcome Measures (submitted: April 28, 2021)

• Change From Baseline in Body Temperature [ Time Frame: 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-6 [ Time Frame: 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 IL-10 [ Time Frame: 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
• Change From Baseline in TNF [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: End-of treatment, Day 7 or 8 ]
  Number of subjects not in need of oxygen supply at the end of treatment
• Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation [ Time Frame: 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
• Time to Need of Mechanical Invasive or Non-invasive Ventilation [ Time Frame: Treatment period of 7 days ]
  Time to need of mechanical invasive or non-invasive ventilation during treatment period
• Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation) [ Time Frame: 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)
• Adverse Events [ Time Frame: 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of C21 in Subjects With COVID-19
• 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

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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: COVID-19

Intervention

• Drug: C21
  C21
• Drug: Placebo
  Placebo

Study Arms

• Experimental: C21 100 mg twice daily
  Oral C21 treatment 100 mg twice daily for 7 days
  Intervention: Drug: C21
• Placebo Comparator: Placebo
  Oral placebo treatment 100 mg twice daily for 7 days
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 28, 2021): 206
• Original Estimated Enrollment (submitted: June 29, 2020): 100
• Actual Study Completion Date: October 13, 2020
• Actual Primary Completion Date: October 13, 2020 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India, United Kingdom

Administrative Information

• NCT Number: NCT04452435
• Other Study ID Numbers: VP-C21-006; 2020-001502-38 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Vicore Pharma AB
• Original Responsible Party: Same as current
• Current Study Sponsor: Vicore Pharma AB
• Original Study Sponsor: Same as current
• Collaborators: Orphan Reach

Investigators

• Principal Investigator: Joanna Porter, MD; Respiratory Medicine, University College Hospital

• PRS Account: Vicore Pharma AB
• Verification Date: June 2021