NCT04364815

The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial

Efficacy and Safety of Hydroxychloroquine for COVID-19 Post-Exposure Prophylaxis of Healthcare Workers in the Philippine General Hospital and UP Manila National Institutes of Health: A Randomized, Double-blind, Placebo-controlled Trial

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of the Philippines · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine plus standard preventive measures	Hydroxychloroquine and standard preventive measures
DRUG	Placebo plus standard preventive measures	Placebo tablet plus standard preventive measures as defined by PGH-HICU

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-04-28
• Last updated: 2020-11-06

Locations

1 site across 1 country: Philippines