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Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19

NCT04414241 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-10-28

No results posted yet for this study

Summary

The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.

Conditions

Interventions

DRUG

Hydroxychloroquine

A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.

Sponsors & Collaborators

  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • Alejandro Llanos, MD, PhD · Universidad Peruana Cayetano Heredia

  • Eduardo Gotuzzo, MD · Universidad Peruana Cayetano Heredia

  • Max Grogl, PhD · U.S. Naval Medical Research Unit Six

  • Patricia García, MD, MPH, PhD · Universidad Peruana Cayetano Heredia

  • Manuel Espinoza, MD · Instituto de Nacional de Salud

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2020-11-23
Completion
2020-11-23

Countries

  • Peru

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04414241 on ClinicalTrials.gov