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A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients

Sponsor
Qurient Co., Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04847583
Collaborator
(none)
1
Enrollment
3
Locations
2
Arms
6.5
Actual Duration (Months)
0.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2, open-label, randomized controlled trial to determine the effects of Telacebec (Q203) on inhibition of leukotriene production, clinical change, pharmacokinetics, and safety in participants with moderate COVID-19 disease

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Open-Label, Randomized Controlled Trial to Evaluate the Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec in Participants With Moderate COVID-19 Disease
Actual Study Start Date :
Jul 29, 2021
Actual Primary Completion Date :
Feb 11, 2022
Actual Study Completion Date :
Feb 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telacebec (Q203) with COVID-19 standard of care (SoC)

Drug: Telacebec
Telacebec 100 mg tablet
Other Names:
  • Q203

    • Drug: COVID-19 Standard of care
    The Standard of Care treatment and administration thereof will be determined by the Investigator
    Active Comparator: COVID-19 Standard of care (SoC)

    Drug: COVID-19 Standard of care
    The Standard of Care treatment and administration thereof will be determined by the Investigator

    Outcome Measures

    Primary Outcome Measures

    1. Biomarker change [Day 1 and 14]

      Percentage Inhibition of whole blood Leukotriene B4 (LTB4) production at 4 hours post dose SoC versus SoC plus telacebec

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Provide written, informed consent prior to all study-related procedures.

    2. Provide written, informed consent to undergo Human Immunodeficiency Virus (HIV) testing.

    3. Willingness and ability to attend scheduled visits and undergo study assessments.

    4. Able and willing to measure their oxygen saturation level and temperature, record their COVID-19 symptoms and complete a patient diary.

    5. Male or female aged 18 years or older.

    6. Confirmed and documented SARS-CoV-2 infection, defined as RT-PCR laboratory confirmation.

    7. Clinical and/or radiological findings indicative of moderate COVID-19 disease

    Exclusion Criteria:

    1. Severe or critical COVID-19 disease at enrollment (Day 1) (per NIH Treatment Guideline categorization) as determined by the Investigator.

    2. Inability to swallow oral medication.

    3. Concurrent known asthma, active tuberculosis or tuberculosis within the last 3 months, or any other condition that could compromise the well-being of the participant, or prevent, limit or confound protocol specified assessments, in the opinion of the Investigator.

    4. Female Participant who is pregnant, breast-feeding, or planning to conceive a child within the anticipated period of participating in the study or within 6 months after last dose of study medication. Males planning to conceive a child during the study or within 6 months of cessation of treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chris Hani Baragwanath Academic Hospital Soweto Gauteng South Africa
    2 KwaPhila Health Solutions Durban Kwa-Zula Natal South Africa
    3 TASK Eden George Western Cape South Africa

    Sponsors and Collaborators

    • Qurient Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qurient Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04847583
    Other Study ID Numbers:
    • Q203-COVID-P2-ZA001
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 2, 2022