Status:
UNKNOWN
Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM)
Lead Sponsor:
University of Malaga
Collaborating Sponsors:
Instituto de Investigacion Biomedica de Malaga
Carlos III Health Institute
Conditions:
Sars-CoV2
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the res...
Detailed Description
The objective of this study is to evaluate the effectiveness of hydroxychloroquine chemoprophylaxis in healthcare personnel and residents: 1. the incidence of secondary cases of SARS-CoV-2 infection ...
Eligibility Criteria
Inclusion
- Institutionalized people in nurswing homes since the beginning of the COVID19 epidemic who do not have the infection present at the time of entering into the study.
- Healthcare professionals who provide direct care (nursing assistants and registered nurses) to institutionalized older people in nursing homes with confirmed cases of COVID19 during the past 8 days.
- Subjects that give their consent to participate in the study or that it be obtained from their representative / legal guardian.
Exclusion
- Staff members who do not provide direct care to residents.
- Residents with active SARS-CoV-2 infection present, or with symptoms compatible with COVID19 confirmed by PCR test.
- Staff members with present or past SARS-CoV-2 infection, or with PCR-confirmed symptoms consistent with COVID19.
- History of QT interval prolongation or arrhythmias of any etiology.
- Presence of retinopathy of any etiology, changes in acuity or visual field.
- Severe hearing loss (requires the use of hearing aids).
- Structural heart disease.
- History of non-structural heart failure, ischemic heart disease, SCASEST, or SCACEST
- Chronic liver disease.
- Alcoholism.
- Epilepsy.
- For the participating professionals, pregnancy or suspected pregnancy (if they are planning pregnancy, or in fertilizer treatment, they must abandon the study).
- Subjects with known HDQ hypersensitivity.
- Subjects diagnosed with G6PDH deficiency.
- Taking other medicines that prolong QT: domperidone, ondansetron, cilostazol, antiarrhythmics (procainamide, amiodarone, flecainide, sotalol), macrolides (azithromycin, clarithromycin, erythromycin), quinolones (ciprofloxacin,), moxofloxacin,) neuroleptics (haloperidol, chlorpromazine, pimozide), antidepressants (citalopram, escitalopram), sulpiride, anticholinesterase drugs (donepezil)
- Denial to participate in the study
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
1930 Patients enrolled
Trial Details
Trial ID
NCT04400019
Start Date
September 1 2020
End Date
April 1 2021
Last Update
September 29 2020
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