COVID19Phase 3COVID_2ProNCT04349228
Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals
A Phase 3 study testing Hydroxychloroquine (HCQ) in people with COVID19 and Sars-CoV2, run by Abderrahmane Mami Hospital at 1 site in Tunisia.
Trial summary
Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID19, Sars-CoV2, Hydroxychloroquine
- What is being tested?
- Hydroxychloroquine (HCQ)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTunisia
- Study dates
- 28 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of COVID-19 (-)
- Works in a medical intensive care unit exposed to COVID-19 infection
- 18 years old < age < 65 years old
- Having given written consent for their participation in the study.
Who cannot join
- Diagnosis of COVID-19+
- Retinopathies,
- Hydroxychloroquine or other prophylactic treatments for VIDOC19 within one month prior to inclusion and throughout the study.
- Hypersensitivity to chloroquine or hydroxychloroquine or 4-aminoquinolines or any of the other components of this drug,
- Contraindication to prophylactic use of chloroquine, e.g. liver failure, known epilepsy, creatinine clearance < 30 ml/min.
- Inability to be monitored during the trial period
- Pregnancy and breastfeeding
- Psoriasis
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Tunis
About this study
Official title: Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study
Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study
Read the detailed description
Interventional, Multicentric, Randomized Controlled Study in Two Parallel Groups of 530 Healthcare Professionals working in the Intensive Care Unit Exposed to Risk of COVID19 Infection Taking Hydroxychloroquine (HCQ) (200 mg/day) VS Placebo
- Conditions
- COVID19, Sars-CoV2, Hydroxychloroquine, Prophylaxis, Healthcare Worker
- Being tested
- Hydroxychloroquine (HCQ), Placebo oral tablet
- Keywords
- HCQ, prophylaxie, Healthcare Worker, Hydroxychloroquine, COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine (HCQ)Drug
Also called Plaquenil
Hydroxychloroquine (HCQ) 200mg/day
Placebo oral tabletDrug
Also called Placebo of Plaquenil
Placebo of Hydroxychloroquine (HCQ) without any active substance
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine (HCQ) | Experimental | Exposed health care professionals working in the intensive care unit Receives: Drug: Hydroxychloroquine (HCQ) |
| Placebo | Placebo comparator | Exposed health care professionals working in the intensive care unit Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic COVID(+) infection rate
- Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below:
- Cough
- Dyspnea
- Fever
- Myalgia
- Arthralgia
- Rhinorrhea
- Anosmia
- Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period.
- Biological Examination :
- Measurement of viral load
- Ion, liver, kidney, haematological assessment
- Electrical Examination: ECG
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start28 Apr 2020
- 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 COVID19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm1:Hydroxychloroquine (HCQ) (200 mg / day) for at least 2 months or until potential contamination\*\*. Arm2:Placebo (1 tablet/day) for at least 2 months or until potential contamination\*\*. \*\* If the participant is contaminated (COVID19+), he or she will be followed up by telephone according to the study schedule.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- 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
- Investigators
- Jalila Ben Khelil, Pr, Principal investigator, Hopital Abderrahmane Mami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349228
- Sponsor's protocol ID
- ECC2020-03
- Acronym
- COVID_2Pro
- Status last verified
- Aug 2020
- First submitted
- 14 Apr 2020
- Last updated
- 28 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 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04349228
- Acronym / sponsor ID
- COVID_2Pro / ECC2020-03
- Conditions
- COVID19, Sars-CoV2, Hydroxychloroquine, Prophylaxis, Healthcare Worker
- Keywords
- HCQ, prophylaxie, Healthcare Worker, Hydroxychloroquine, COVID19
- 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
- 28 Apr 2020 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 16 Apr 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.
Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study
Detailed description
Interventional, Multicentric, Randomized Controlled Study in Two Parallel Groups of 530 Healthcare Professionals working in the Intensive Care Unit Exposed to Risk of COVID19 Infection Taking Hydroxychloroquine (HCQ) (200 mg/day) VS Placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Arm1:Hydroxychloroquine (HCQ) (200 mg / day) for at least 2 months or until potential contamination**. Arm2:Placebo (1 tablet/day) for at least 2 months or until potential contamination**. ** If the participant is contaminated (COVID19+), he or she will be followed up by telephone according to the study schedule.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine (HCQ) | Experimental | Drug: Hydroxychloroquine (HCQ)Exposed health care professionals working in the intensive care unit |
| Placebo | Placebo comparator | Drug: Placebo oral tabletExposed health care professionals working in the intensive care unit |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COVID-19 (-)
- Works in a medical intensive care unit exposed to COVID-19 infection
- 18 years old < age < 65 years old
- Having given written consent for their participation in the study.
Key exclusion criteria (8 listed)
- Diagnosis of COVID-19+
- Retinopathies,
- Hydroxychloroquine or other prophylactic treatments for VIDOC19 within one month prior to inclusion and throughout the study.
- Hypersensitivity to chloroquine or hydroxychloroquine or 4-aminoquinolines or any of the other components of this drug,
- Contraindication to prophylactic use of chloroquine, e.g. liver failure, known epilepsy, creatinine clearance < 30 ml/min.
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 |
|---|---|---|
| Hydroxychloroquine (HCQ)Also: PlaquenilHydroxychloroquine (HCQ) 200mg/day | Drug | Hydroxychloroquine (HCQ) |
| Placebo oral tabletAlso: Placebo of PlaquenilPlacebo of Hydroxychloroquine (HCQ) without any active substance | Drug | Placebo |
Primary outcome
Symptomatic COVID(+) infection rate
Time frame: 60 days
* Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below: * Cough * Dyspnea * Fever * Myalgia * Arthralgia * Rhinorrhea * Anosmia * Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period. * Biological Examination : * Measurement of viral load * Ion, liver, kidney, haematological assessment * Electrical Examination: ECG
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 28 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.
Jalila Ben Khelil, Pr principal investigator
Hopital Abderrahmane Mami
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 Hydroxychloroquine (HCQ) in people with COVID19 and Sars-CoV2, 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 4 inclusion and 8 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 28 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. Some participants in this study may receive a placebo. 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?
Symptomatic COVID(+) infection rate (time frame: 60 days). 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 28 Aug 2020.