Safety and Efficacy of C21 in Subjects With COVID-19

June 21, 2021 updated by: Vicore Pharma AB

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Ahmadabad, Gujarat, India, 380016
        • Department of Medicine, Civil Hospital and B J Medical College
      • Surat, Gujarat, India, 395001
        • Infectious Disease, Metas Adventist Hospital
      • Surat, Gujarat, India, 395010
        • Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
      • Vadodara, Gujarat, India, 290022
        • First Floor Clinical Research Department Rhythm Heart Institute
    • Maharashtra
      • Mumbai, Maharashtra, India, 400016
        • Internal Medicine S.L. Raheja Hospital
      • Nagpur, Maharashtra, India, 440003
        • Department of Medicine, Government Medical College and Hospital
      • Pune, Maharashtra, India, 411001
        • Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic
      • Pune, Maharashtra, India
        • Department of Medicine, Noble Hospitals Pvt. Ltd
  • United Kingdom
      • London, United Kingdom, WC1E 6BT
        • Respiratory Medicine, University College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Treatment period of 7 days (Day 1 to Day 8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Treatment period of 7 days ((Day 1 to Day 8)
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
Treatment period of 7 days (Day 1 to Day 8)
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
Treatment period of 7 days (Day 1 to Day 8)
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.
Treatment period of 7 days (Day 1 to Day 8)
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
Treatment period of 7 days (Day 1 to Day 8)
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.
Treatment period of 7 days (Day 1 to Day 8)
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
End-of treatment, Day 7 or 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
Treatment period of 7 days (Day 1 to Day 8)
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
Treatment period of 7 days
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)
Treatment period of 7 days (Day 1 to Day 8)
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.
Day 1 to end-of-trial (Visit 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vicore Pharma AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Orphan Reach

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joanna Porter, MD, Respiratory Medicine, University College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VP-C21-006
  • 2020-001502-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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