Status:
TERMINATED
A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients
Lead Sponsor:
Qurient Co., Ltd.
Conditions:
COVID-19 Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 partic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04847583
Start Date
July 29 2021
End Date
February 11 2022
Last Update
March 2 2022
Active Locations (3)
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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