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This COVID-19 pandemic warrants urgent strategies to protect people at high risk of infection, particularly the healthcare workers. Secondary prevention through post-exposure prophylaxis (PEP) and early treatment of infection are needed to prevent severe cases and cut secondary transmission. Hydroxycholoroquine (HCQ) is an inexpensive anti-malarial drug with immunomodulatory effects that are currently used as an off-label treatment for symptomatic COVID-19 patients. In vitro studies have shown that it can efficiently inhibit SARS-CoV-2 infection and has potential as a post-exposure prophylaxis drug.
Full description
To compare the efficacy and safety of hydroxychloroquine with an oral loading dose of 400 mg two times a day on D1 followed by 400mg/day from Day 2-10 plus standard preventive measures and standard preventive measures alone as post-exposure prophylaxis for healthcare workers in a Metro Manila COVID Referral Center
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Inclusion criteria
any medical or non-medical personnel of the Philippine General Hospital and the UP Manila National Institutes of Health to include physicians (consultants, fellows-in-training, residents-in-training); nurses and other nursing staff (nursing aide, institutional or utility worker); janitors and cleaning staff, medical technologists and personnel of the laboratory where the COVID PCR testing is done; technicians of the radiology department, electrocardiography (ECG) station, arterial blood gas (ABG) stations and other personnel employed by the hospital on a tenured, part-time or full-time,and temporary. Because of the sample size, there is also a plan to include also health care workers in the community quarantine centers in the Manila area such as the Rizal Coliseum or the Ninoy Aquino Stadium, or at the World Trade Center
aged 18-59 years
exposure to a probable or confirmed COVID19 case within 4 days prior to study enrollment that is considered to be medium or high risk as defined by the HICU
asymptomatic (no acute respiratory, flu-like, gastrointestinal signs and symptoms at the time of enrollment
negative baseline COVID19 RT-PCR test result*
for female participants of child bearing potential they must agree to effective birth control methods during the clinical trial or abstinence from any sexual activity during the duration of the study.
Exclusion criteria
active COVID19 disease: positive RT-PCR COVID19 test
prior COVID19 disease
weight less than 40kg or a BMI less than 18kg/m2
current or recent hospitalization within the past year
known allergy to or intolerance of hydroxychloroquine (HCQ) or chloroquine (CQ)
current use of HCQ or CQ for whatever indications (malaria, lupus)
current use of other medication with known antiviral effects
current or known use in the last two weeks of known arrhythmogenic drugs or drugs that prolong the QT interval in the ECG, including but not limited to quinolones, macrolides, amiodarone, digoxin, flecainide, propafenone
any previous known or suspected retinopathy; in case of doubt, an ophthalmology clearance be secured prior to enrollment
known G6PD deficiency discovered through the newborn screening program or known intolerance or allergies to beans and any food that contains beans
women who are pregnant or breastfeeding, or a positive pregnancy test at baseline for women of child bearing age
history of known seizures or treatment with anti-epileptic medications
history of known existing arrhythmia
intake or use of anti diabetic agents especially sulfonylureas or any type of insulin
presence of abnormalities in baseline tests:
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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