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Safety and Efficacy of C21 in Subjects With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Orphan Reach
Information provided by (Responsible Party):
Vicore Pharma AB

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE June 30, 2020
Results First Submitted Date  ICMJE March 24, 2021
Results First Posted Date  ICMJE April 30, 2021
Last Update Posted Date June 23, 2021
Actual Study Start Date  ICMJE July 21, 2020
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of C21 in Subjects With COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: C21
    C21
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2021)
206
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
100
Actual Study Completion Date  ICMJE October 13, 2020
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452435
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party Vicore Pharma AB
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vicore Pharma AB
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Orphan Reach
Investigators  ICMJE
Principal Investigator: Joanna Porter, MD Respiratory Medicine, University College Hospital
PRS Account Vicore Pharma AB
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP