Back to resultsA Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients
Primary Purpose
COVID-19 Virus Infection
Status
Terminated
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Telacebec
COVID-19 Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Virus Infection
Eligibility Criteria
Inclusion Criteria:
- Provide written, informed consent prior to all study-related procedures.
- Provide written, informed consent to undergo Human Immunodeficiency Virus (HIV) testing.
- Willingness and ability to attend scheduled visits and undergo study assessments.
- Able and willing to measure their oxygen saturation level and temperature, record their COVID-19 symptoms and complete a patient diary.
- Male or female aged 18 years or older.
- Confirmed and documented SARS-CoV-2 infection, defined as RT-PCR laboratory confirmation.
- Clinical and/or radiological findings indicative of moderate COVID-19 disease
Exclusion Criteria:
- Severe or critical COVID-19 disease at enrollment (Day 1) (per NIH Treatment Guideline categorization) as determined by the Investigator.
- Inability to swallow oral medication.
- 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.
- 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.
Sites / Locations
- Chris Hani Baragwanath Academic Hospital
- KwaPhila Health Solutions
- TASK Eden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telacebec (Q203) with COVID-19 standard of care (SoC)
COVID-19 Standard of care (SoC)
Arm Description
Outcomes
Primary Outcome Measures
Biomarker change
Percentage Inhibition of whole blood Leukotriene B4 (LTB4) production at 4 hours post dose SoC versus SoC plus telacebec
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04847583
Brief Title
A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's Decision
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qurient Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telacebec (Q203) with COVID-19 standard of care (SoC)
Arm Type
Experimental
Arm Title
COVID-19 Standard of care (SoC)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Telacebec
Other Intervention Name(s)
Q203
Intervention Description
Telacebec 100 mg tablet
Intervention Type
Drug
Intervention Name(s)
COVID-19 Standard of care
Intervention Description
The Standard of Care treatment and administration thereof will be determined by the Investigator
Primary Outcome Measure Information:
Title
Biomarker change
Description
Percentage Inhibition of whole blood Leukotriene B4 (LTB4) production at 4 hours post dose SoC versus SoC plus telacebec
Time Frame
Day 1 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide written, informed consent prior to all study-related procedures.
Provide written, informed consent to undergo Human Immunodeficiency Virus (HIV) testing.
Willingness and ability to attend scheduled visits and undergo study assessments.
Able and willing to measure their oxygen saturation level and temperature, record their COVID-19 symptoms and complete a patient diary.
Male or female aged 18 years or older.
Confirmed and documented SARS-CoV-2 infection, defined as RT-PCR laboratory confirmation.
Clinical and/or radiological findings indicative of moderate COVID-19 disease
Exclusion Criteria:
Severe or critical COVID-19 disease at enrollment (Day 1) (per NIH Treatment Guideline categorization) as determined by the Investigator.
Inability to swallow oral medication.
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.
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.
Facility Information:
Facility Name
Chris Hani Baragwanath Academic Hospital
City
Soweto
State/Province
Gauteng
Country
South Africa
Facility Name
KwaPhila Health Solutions
City
Durban
State/Province
Kwa-Zula Natal
Country
South Africa
Facility Name
TASK Eden
City
George
State/Province
Western Cape
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients
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