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Safety and Efficacy of C21 in Subjects With COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
C21
Placebo
Sponsored by
Vicore Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Medicine, Civil Hospital and B J Medical College
  • Infectious Disease, Metas Adventist Hospital
  • Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
  • First Floor Clinical Research Department Rhythm Heart Institute
  • Internal Medicine S.L. Raheja Hospital
  • Department of Medicine, Government Medical College and Hospital
  • Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic
  • Department of Medicine, Noble Hospitals Pvt. Ltd
  • Respiratory Medicine, University College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

C21 100 mg twice daily

Placebo

Arm Description

Oral C21 treatment 100 mg twice daily for 7 days

Oral placebo treatment 100 mg twice daily for 7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Body Temperature
Change in body temperature from baseline to the average of the last two assessments in the treatment period
Change From Baseline in IL-6
Change in IL-6 from baseline to the average of the last two assessments during the treatment period
Change From Baseline in IL-10
Change in IL-10 from baseline to the average of the last two assessments during the treatment period
Change From Baseline in TNF
Change in TNF from baseline to the average of the last two assessments during the treatment period.
Change From Baseline in CA125
Change in CA125 from baseline to the average of the last two assessments in the treatment period
Change From Baseline in Ferritin
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
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
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 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 on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation)
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.

Full Information

First Posted
June 29, 2020
Last Updated
June 21, 2021
Sponsor
Vicore Pharma AB
Collaborators
Orphan Reach
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1. Study Identification

Unique Protocol Identification Number
NCT04452435
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
October 13, 2020 (Actual)
Study Completion Date
October 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vicore Pharma AB
Collaborators
Orphan Reach

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C21 100 mg twice daily
Arm Type
Experimental
Arm Description
Oral C21 treatment 100 mg twice daily for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo treatment 100 mg twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
C21
Intervention Description
C21
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)
Description
Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period
Time Frame
Treatment period of 7 days (Day 1 to Day 8)
Secondary Outcome Measure Information:
Title
Change From Baseline in Body Temperature
Description
Change in body temperature from baseline to the average of the last two assessments in the treatment period
Time Frame
Treatment period of 7 days ((Day 1 to Day 8)
Title
Change From Baseline in IL-6
Description
Change in IL-6 from baseline to the average of the last two assessments during the treatment period
Time Frame
Treatment period of 7 days (Day 1 to Day 8)
Title
Change From Baseline in IL-10
Description
Change in IL-10 from baseline to the average of the last two assessments during the treatment period
Time Frame
Treatment period of 7 days (Day 1 to Day 8)
Title
Change From Baseline in TNF
Description
Change in TNF from baseline to the average of the last two assessments during the treatment period.
Time Frame
Treatment period of 7 days (Day 1 to Day 8)
Title
Change From Baseline in CA125
Description
Change in CA125 from baseline to the average of the last two assessments in the treatment period
Time Frame
Treatment period of 7 days (Day 1 to Day 8)
Title
Change From Baseline in Ferritin
Description
Change in Ferritin from baseline to the average of the last two assessments during the treatment period.
Time Frame
Treatment period of 7 days (Day 1 to Day 8)
Title
Number of Subjects Not in Need of Oxygen Supply
Description
Number of subjects not in need of oxygen supply at the end of treatment
Time Frame
End-of treatment, Day 7 or 8
Title
Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation
Description
Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period
Time Frame
Treatment period of 7 days (Day 1 to Day 8)
Title
Time to Need of Mechanical Invasive or Non-invasive Ventilation
Description
Time to need of mechanical invasive or non-invasive ventilation during treatment period
Time Frame
Treatment period of 7 days
Title
Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)
Description
Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation)
Time Frame
Treatment period of 7 days (Day 1 to Day 8)
Title
Adverse Events
Description
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.
Time Frame
Day 1 to end-of-trial (Visit 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure 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 Age > 18 and < 70 years CRP > 50 and < 150 mg/l Admitted to a hospital or controlled facility (home quarantine is not sufficient) In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol Exclusion Criteria: Any previous experimental treatment for COVID-19 Need for mechanical invasive or non-invasive ventilation 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 Participation in any other interventional trial within 3 months prior to Visit 1 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) 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 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 Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I Treatment with any of the medications listed below within 1 week prior to Visit 1: Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John's Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbiturates) Warfarin Pregnant or breast-feeding female subjects Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 Male subjects not willing to use contraceptive methods as described in Section 5.3.1 Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Porter, MD
Organizational Affiliation
Respiratory Medicine, University College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Civil Hospital and B J Medical College
City
Ahmadabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Infectious Disease, Metas Adventist Hospital
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395001
Country
India
Facility Name
Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395010
Country
India
Facility Name
First Floor Clinical Research Department Rhythm Heart Institute
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
290022
Country
India
Facility Name
Internal Medicine S.L. Raheja Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400016
Country
India
Facility Name
Department of Medicine, Government Medical College and Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Department of Medicine, Noble Hospitals Pvt. Ltd
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Respiratory Medicine, University College Hospital
City
London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom

12. IPD Sharing Statement

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Safety and Efficacy of C21 in Subjects With COVID-19

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