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- Interest in the use of HCQ is controversial.
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| Name | Class |
|---|---|
| Eshmoun Clinical Research Center | NETWORK |
| Datametrix | INDUSTRY |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine (HCQ) | Experimental | Exposed health care professionals working in the intensive care unit |
|
| Placebo | Placebo Comparator | Exposed health care professionals working in the intensive care unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine (HCQ) | Drug | Hydroxychloroquine (HCQ) 200mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic COVID(+) infection rate |
| 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jalila Ben Khelil, Pr | Hopital Abderrahmane Mami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana | Tunis | Tunisia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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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.
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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.
| Placebo oral tablet | Drug | Placebo of Hydroxychloroquine (HCQ) without any active substance |
|
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |