Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals (COVID_2Pro)
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ClinicalTrials.gov Identifier: NCT04349228 |
Recruitment Status :
Withdrawn
(- Interest in the use of HCQ is controversial.)
First Posted : April 16, 2020
Last Update Posted : August 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID19 Sars-CoV2 Hydroxychloroquine Prophylaxis Healthcare Worker | Drug: Hydroxychloroquine (HCQ) Drug: Placebo oral tablet | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Outcomes Assessor) |
Masking Description: | As the trial is open-label and to preserve the validity of the trial, the measurement of the endpoint must be blinded by a third party (i.e., an evaluator who is not aware of the arm to which the patient has been assigned or the treatment the patient is receiving) using the PROBE ("Prospective Randomized Open Blinded Endpoint") method. |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | April 28, 2020 |
Estimated Primary Completion Date : | July 15, 2020 |
Estimated Study Completion Date : | July 15, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Hydroxychloroquine (HCQ)
Exposed health care professionals working in the intensive care unit
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Drug: Hydroxychloroquine (HCQ)
Hydroxychloroquine (HCQ) 200mg/day
Other Name: Plaquenil |
Placebo Comparator: Placebo
Exposed health care professionals working in the intensive care unit
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Drug: Placebo oral tablet
Placebo of Hydroxychloroquine (HCQ) without any active substance
Other Name: Placebo of Plaquenil |
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349228
Tunisia | |
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana | |
Tunis, Tunisia |
Principal Investigator: | Jalila Ben Khelil, Pr | Hopital Abderrahmane Mami |
Responsible Party: | Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami Hospital |
ClinicalTrials.gov Identifier: | NCT04349228 |
Other Study ID Numbers: |
ECC2020-03 |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | August 28, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HCQ prophylaxie Healthcare Worker Hydroxychloroquine COVID19 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Hydroxychloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |