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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Hydroxychloroquine and standard preventive measures
Placebo tablet plus standard preventive measures as defined by PGH-HICU
Philippine General Hospital - University of the Philippines Manila
Manila, Philippines
Efficacy of HCQ Prophylaxis in Preventing COVID-19 infection
Incidence of COVID-19 infection confirmed by RT-PCR COVID-19 test within the PEP treatment period (28 days) with or without symptoms of COVID-19 infection
Time frame: 30 days
Efficacy of study drug as post-exposure prophylaxis in preventing COVID-19 related symptoms (to be reported as absolute number and frequency of events)
Incidence of patient self-reported COVID-19 related symptoms anytime during follow up period as measured by a standardized patient diary
Time frame: 30 days
Time to COVID-19 infection in patients receiving study drug (in days)
Interval from exposure to COVID-19 case Interval from first dose of study drug
Time frame: 30 days
Safety and tolerability of study drug (to be reported as absolute number and frequency of events)
Incidence of study drug discontinuation Incidence of all adverse events based on patients a) self-report using daily symptom diary and b) study physicians
Time frame: 30 days
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