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Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)

NCT04466540 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1372

Last updated 2022-03-07

No results posted yet for this study

Summary

In December 2019, a group of patients with pneumonia of unknown cause was identified in Wuhan, in the Hubei province, China. Despite the need of target specific therapeutic options for COVID-19, until now there is no proof of effectiveness of any specific intervention. Some limited observational trials and also evidence from randomized trials have shown no benefit of hydroxychloroquine in inpatient context. Thus, studies evaluating interventions in an outpatient setting in non-severe patients can provide important information related to prognosis and safety. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine in COVID-19 outpatients by means of a Randomized, double-blind, placebo-controlled trial

Conditions

Interventions

DRUG

Hydroxychloroquine

Hydroxychloroquine pharmaceutical form will be tablets of 400 mg.

DRUG

Placebo

Hydroxychloroquine placebo

Sponsors & Collaborators

  • EMS S/A

    collaborator UNKNOWN

  • Hospital do Coracao

    collaborator OTHER

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • Hospital Sirio-Libanes

    collaborator OTHER

  • Hospital Moinhos de Vento

    collaborator OTHER

  • Brazilian Research In Intensive Care Network

    collaborator NETWORK

  • Hospital Alemão Oswaldo Cruz

    lead OTHER

Principal Investigators

  • Álvaro Avezum, Ph.D · International Research Center - Hospital Alemão Oswaldo Cruz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-12
Primary Completion
2021-07-28
Completion
2021-09-28

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
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 NCT04466540 on ClinicalTrials.gov