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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: C21 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 21, 2020
Actual Primary Completion Date : October 13, 2020
Actual Study Completion Date : October 13, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452435


Locations
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India
Department of Medicine, Civil Hospital and B J Medical College
Ahmadabad, Gujarat, India, 380016
Infectious Disease, Metas Adventist Hospital
Surat, Gujarat, India, 395001
Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
Surat, Gujarat, India, 395010
First Floor Clinical Research Department Rhythm Heart Institute
Vadodara, Gujarat, India, 290022
Internal Medicine S.L. Raheja Hospital
Mumbai, Maharashtra, India, 400016
Department of Medicine, Government Medical College and Hospital
Nagpur, Maharashtra, India, 440003
Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, India, 411001
Department of Medicine, Noble Hospitals Pvt. Ltd
Pune, Maharashtra, India
United Kingdom
Respiratory Medicine, University College Hospital
London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
Vicore Pharma AB
Orphan Reach
Investigators
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Principal Investigator: Joanna Porter, MD Respiratory Medicine, University College Hospital
  Study Documents (Full-Text)

Documents provided by Vicore Pharma AB:
Study Protocol and Statistical Analysis Plan: Study Protocol  [PDF] August 14, 2020
Statistical Analysis Plan: Statistical Analysis Plan  [PDF] September 10, 2020

More Information
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Responsible Party: Vicore Pharma AB
ClinicalTrials.gov Identifier: NCT04452435    
Other Study ID Numbers: VP-C21-006
2020-001502-38 ( EudraCT Number )
First Posted: June 30, 2020    Key Record Dates
Results First Posted: April 30, 2021
Last Update Posted: June 23, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vicore Pharma AB:
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases