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Completed

NCT Number: NCT04452435

Safety and Efficacy of C21 in Subjects With COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Medicine, Civil Hospital and B J Medical College, Ahmedabad, Gujarat, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

C21

Drug

C21

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vicore Pharma AB

Industry

Collaborators

  • Orphan Reach Ltd.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2020
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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