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Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-Cov-2 Virus (COVID-19)

NCT04322123 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 667

Last updated 2022-04-05

No results posted yet for this study

Summary

Coronavirus (COVID-19) is a somewhat new and recognized infectious disease that is now spreading to several countries in the world, including Brazil. Hydroxychloroquine and azithromycin may be useful for treating those patients.

COALITION I study aims to compared standard of care, hydroxychloroquine plus azithromycin and hydroxychloroquine monotherapy for treatment of hospitalized patients with COVID-19.

COALITION I will recruit 630 patients with infection by COVID-19 (210 per arm). Ordinal endpoint of status at 15 days will be the primary endpoint.

Conditions

  • Coronavirus Infections

Interventions

DRUG

Hydroxychloroquine Oral Product

Hydroxychloroquine 400 mg BID

DRUG

Hydroxychloroquine + azithromycin

Hydroxychloroquine 400 mg BID + azithromycin 500 mg once a day

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • Hospital Sirio-Libanes

    collaborator OTHER

  • Brazilian Research In Intensive Care Network

    collaborator NETWORK

  • EMS

    collaborator INDUSTRY

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Alexandre Biasi, PhD · Hospital do Coração

  • Otavio Berwanger · Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2020-06-02
Completion
2020-06-02

Countries

  • Brazil

Study Locations

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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 NCT04322123 on ClinicalTrials.gov