COVID19 Clinical Trial
— COVID_2ProOfficial 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
Verified date | August 2020 |
Source | Abderrahmane Mami Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 15, 2020 |
Est. primary completion date | July 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Tunisia | Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana | Tunis |
Lead Sponsor | Collaborator |
---|---|
Abderrahmane Mami Hospital | Datametrix, Eshmoun Clinical Research Centre |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
60 days |
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