COVID19 Clinical Trial
— COVID-MilitOfficial title:
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia
Status | Not yet recruiting |
Enrollment | 660 |
Est. completion date | July 31, 2020 |
Est. primary completion date | May 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - No self-medication with chloroquine, hydroxychloroquine or antivirals - COVID-19 negative diagnosis confirmed by "rapid test" and "PCR test" (Polymerase Chain Reaction test) - No clinical symptoms suggestive of COVID-19 - Having given written consent for their participation in the study Exclusion Criteria: - Participation in other clinical trials for the treatment or prevention of SARS-COV-2 infection within 30 days before inclusion - Hypersensitivity to any of the drugs or to any of its excipients. - ECG showing rhythm disturbances, QT interval> 500 ms, conduction disturbances. - Severe hepatic impairment. - Concomitant treatments : colchicin, ergot of rye, pimozide, mizolastin, simvastatin, lomitapide, alfuzosin, dapoxetin, avanafil, ivabradin, eplerenone, dronedaron, quetiapine, ticagrelor, cisapride, astemizole, astemizol. - Retinal pathology. - Epilepsy. - Myasthenia. - Psoriasis. - Methemoglobinemia. - Porphyria. - Pregnant or lactating women - Contraindication to the study products |
Country | Name | City | State |
---|---|---|---|
Tunisia | Military Hospital of Tunis | Tunis |
Lead Sponsor | Collaborator |
---|---|
Military Hospital of Tunis | Dacima Consulting, UR17DN02 : Autoimmune Diseases Research Unit |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SARS CoV2 infection | Frequency of confirmed SARS CoV2 infection | At 2 months of follow-up | |
Secondary | COVID-19 symptoms description | Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness) | At 2 months of follow-up | |
Secondary | Adverse Events | Any adverse event or serious adverse event | each month up to 2 months |
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