COVID-19 Virus InfectionPhase 2NCT04847583
A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients
A Phase 2 study testing Telacebec in people with COVID-19 Virus Infection, run by Qurient Co., Ltd. at 3 sites in South Africa.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Virus Infection
- What is being tested?
- Telacebec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 29 Jul 2021to 11 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
KwaPhila Health Solutions
Durban, Kwa-Zula Natal
TASK Eden
George, Western Cape
Chris Hani Baragwanath Academic Hospital
Soweto, Gauteng
About this study
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
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
- Conditions
- COVID-19 Virus Infection
- Being tested
- Telacebec, COVID-19 Standard of care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelacebecDrug
Also called Q203
Telacebec 100 mg tablet
COVID-19 Standard of careDrug
The Standard of Care treatment and administration thereof will be determined by the Investigator
| Study group | Role | What they receive |
|---|---|---|
| Telacebec (Q203) with COVID-19 standard of care (SoC) | Experimental | Not described Receives: Drug: Telacebec; Drug: COVID-19 Standard of care |
| COVID-19 Standard of care (SoC) | Active comparator | Not described Receives: Drug: COVID-19 Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker change
Percentage Inhibition of whole blood Leukotriene B4 (LTB4) production at 4 hours post dose SoC versus SoC plus telacebec
Measured: Day 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start29 Jul 2021
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
Why it stopped: Sponsor's Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qurient Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847583
- Sponsor's protocol ID
- Q203-COVID-P2-ZA001
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04847583
- Acronym / sponsor ID
- Q203-COVID-P2-ZA001
- Conditions
- COVID-19 Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's Decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Qurient Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telacebec (Q203) with COVID-19 standard of care (SoC) | Experimental | Drug: Telacebec, Drug: COVID-19 Standard of care |
| COVID-19 Standard of care (SoC) | Active comparator | Drug: COVID-19 Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelacebecAlso: Q203Telacebec 100 mg tablet | Drug | Telacebec (Q203) with COVID-19 standard of care (SoC) |
| COVID-19 Standard of careThe Standard of Care treatment and administration thereof will be determined by the Investigator | Drug | COVID-19 Standard of care (SoC), Telacebec (Q203) with COVID-19 standard of care (SoC) |
Primary outcome
Biomarker change
Time frame: Day 1 and 14
Percentage Inhibition of whole blood Leukotriene B4 (LTB4) production at 4 hours post dose SoC versus SoC plus telacebec
Results and safety
The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telacebec in people with COVID-19 Virus Infection, run by Qurient Co., Ltd. at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker change (time frame: Day 1 and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.