COVID 19Phase 3THINCNCT04528927
Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia
A Phase 3 study testing HCQ, Azithromycin and Doxycycline in people with COVID 19 and Patients Hospitalized, run by Abderrahmane Mami Hospital at 1 site in Tunisia.
Trial summary
Evaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID 19, Patients Hospitalized
- What is being tested?
- HCQ, Azithromycin and Doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTunisia
- Study dates
- 15 May 2020to 15 Jul 2020
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed patient COVID19 positive with clinical signs of acute lower respiratory infection with signs of pneumonia or bronchitis: fever and / or cough and / or difficulty breathing in the absence of acute respiratory failure (PaO2> 60 mmHg) with Plus or less :
- Chills
- Asthenia, fatigability
- Headache
- Arthromas myalgia
- Dry throat
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- Rhinorrhea
- An anosmia
- chest pain
- Diarrhea
- Nausea and vomiting
- Absence of rhythm disturbance (Qt interval <500ms)
- Patients hospitalized in the medical service
- 18 years old <Age <80 years old
- Having given written consent for their participation in the study
Who cannot join
- Allergy to macrolides, local anesthetics such as lidocaine or amide type and betalactamines
- Take hydroxychloquine in the previous month
- Severe / severe liver failure
- Kidney failure (GFR <30 ml / min / 1.73 m2)
- Ongoing treatments with colchicine, ergot, rye, pimozide, mizolastine, simvastatin, lomitapide, alfuzosin, dapoxetine, avanafil, ivabradine, eplerenone, dronedarone, quetiapine, ticagrelor, cisapride, astemizole, terfenadine, ranolazine, domperidone.
- Complete branch block
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- Hypovolemia
- Retinopathy including vitreous involvement
- Psoriasis
- Pregnant or breastfeeding woman
- hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients of this medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia Multicentric Randomized Comparative Study
Evaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study
Read the detailed description
Arm 1:
- Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Usual standard treatment
Arm 2:
- HCQ: 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Zinc: 220 mg per day for 10 days
- Usual standard treatment
Arm 3:
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Doxycycline: 200 mg per day for 10 days.
- Usual standard treatment
- Conditions
- COVID 19, Patients Hospitalized
- Being tested
- HCQ, Azithromycin, Doxycycline, Zinc
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCQDrug
600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days
AzithromycinDrug
500 mg (1st day) then 250 mg / D for 4 days
DoxycyclineDrug
200 mg per day for 10 days
ZincDietary supplement
220 mg per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| HCQ+Azithromycin | Experimental | * Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
* Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
* Usual standard treatment Receives: Drug: HCQ; Drug: Azithromycin |
| HCQ+Azithromycin+Zinc | Experimental | * HCQ: 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
* Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
* Zinc: 220 mg per day for 10 days
* Usual standard treatment Receives: Drug: HCQ; Drug: Azithromycin; Dietary Supplement: Zinc |
| Azithromycin+Doxycycline | Experimental | * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
* Doxycycline: 200 mg per day for 10 days.
* Usual standard treatment Receives: Drug: Azithromycin; Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the rate of patients cured at the end of the study.
The healing criteria are defined clinically as:
disappearance of clinical signs of acute respiratory infection absence of fever
Measured: 2 months
Evaluate the rate of patients are pauci-symptomatic at the end of the study.
A patient will be defined as pauci-symptomatic if presence:
- Light dry cough
- Discomfort,
- More or less :
- Headache,
- Muscle pain
Measured: 2 months
Secondary outcomes (1)
Evaluate the rate of patients with worsening clinical signs
Patients require transfer to intensive care with the appearance of:
- Acute respiratory failure: PaO2 <60 mmHg in AA gold
- Signs of circulatory insufficiency: mottling, tachycardia, systolic BP ≤90mmHg or having dropped by 40 mmHg compared to base BP or
- Confusion or alteration of the state of consciousness
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start15 May 2020 (estimated)
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Why it stopped: \- Interest in the use of HCQ is controversial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abderrahmane Mami Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eshmoun Clinical Research Center, Datametrix
- Responsible party
- Principal investigator, Dr Jalila Ben Khelil, Abderrahmane Mami Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528927
- Sponsor's protocol ID
- ECC2020-05
- Acronym
- THINC
- Status last verified
- Aug 2020
- First submitted
- 6 May 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia Multicentric Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04528927
- Acronym / sponsor ID
- THINC / ECC2020-05
- Conditions
- COVID 19, Patients Hospitalized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: \- Interest in the use of HCQ is controversial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abderrahmane Mami HospitalUniversity, hospital or other
- Collaborators
- Eshmoun Clinical Research Center, Datametrix
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 27 Aug 2020 (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.
Evaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study
Detailed description
Arm 1:
- Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Usual standard treatment
Arm 2:
- HCQ: 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Zinc: 220 mg per day for 10 days
- Usual standard treatment
Arm 3:
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Doxycycline: 200 mg per day for 10 days.
- Usual standard treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| HCQ+Azithromycin | Experimental | Drug: HCQ, Drug: Azithromycin* Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Usual standard treatment |
| HCQ+Azithromycin+Zinc | Experimental | Drug: HCQ, Drug: Azithromycin, Dietary Supplement: Zinc* HCQ: 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Zinc: 220 mg per day for 10 days * Usual standard treatment |
| Azithromycin+Doxycycline | Experimental | Drug: Azithromycin, Drug: Doxycycline* Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Doxycycline: 200 mg per day for 10 days. * Usual standard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Confirmed patient COVID19 positive with clinical signs of acute lower respiratory infection with signs of pneumonia or bronchitis: fever and / or cough and / or difficulty breathing in the absence of acute respiratory failure (PaO2> 60 mmHg) with Plus or less :
Key exclusion criteria (11 listed)
- Allergy to macrolides, local anesthetics such as lidocaine or amide type and betalactamines
- Take hydroxychloquine in the previous month
- Severe / severe liver failure
- Kidney failure (GFR <30 ml / min / 1.73 m2)
- Ongoing treatments with colchicine, ergot, rye, pimozide, mizolastine, simvastatin, lomitapide, alfuzosin, dapoxetine, avanafil, ivabradine, eplerenone, dronedarone, quetiapine, ticagrelor, cisapride, astemizole, terfenadine, ranolazine, domperidone.
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 |
|---|---|---|
| HCQ600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days | Drug | HCQ+Azithromycin, HCQ+Azithromycin+Zinc |
| Azithromycin500 mg (1st day) then 250 mg / D for 4 days | Drug | Azithromycin+Doxycycline, HCQ+Azithromycin, HCQ+Azithromycin+Zinc |
| Doxycycline200 mg per day for 10 days | Drug | Azithromycin+Doxycycline |
| Zinc220 mg per day for 10 days | Dietary supplement | HCQ+Azithromycin+Zinc |
Primary outcome
Evaluate the rate of patients cured at the end of the study.
Time frame: 2 months
The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever
Evaluate the rate of patients are pauci-symptomatic at the end of the study.
Time frame: 2 months
A patient will be defined as pauci-symptomatic if presence: * Light dry cough * Discomfort, * More or less : * Headache, * Muscle pain
1 secondary outcome
Evaluate the rate of patients with worsening clinical signs
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HCQ, Azithromycin and Doxycycline in people with COVID 19 and Patients Hospitalized, run by Abderrahmane Mami Hospital at 1 site in Tunisia.
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 15 inclusion and 11 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: withdrawn, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Evaluate the rate of patients cured at the end of the study. (time frame: 2 months). The study lists 2 primary outcomes in all. 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 27 Aug 2020.