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Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)

NCT04321278 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2021-01-20

No results posted yet for this study

Summary

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.

Conditions

  • Coronavirus Infections
  • Pneumonia, Viral

Interventions

DRUG

Hydroxychloroquine + azithromycin

Intervention Group: Hydroxychloroquine + azithromycin. After randomization, Hydroxychloroquine \[400mg 2x/day, 12/12h\] + azithromycin \[500mg 1x/day\]) for 10 days. Standard treatment is according to the treatment protocol for 2019-nCoV infection.

DRUG

Hydroxychloroquine

Active Control Group: Hydroxychloroquine. After randomization, Hydroxychloroquine \[400mg 2x/day, 12/12h\] for 10 days. Standard treatment is according to the treatment protocol for 2019-nCoV infection.

Sponsors & Collaborators

  • EMS

    collaborator INDUSTRY

  • Hospital do Coracao

    collaborator OTHER

  • Hospital Sirio-Libanes

    collaborator OTHER

  • Brazilian Research In Intensive Care Network

    collaborator NETWORK

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Otávio Berwanger, PhD · 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
2020-03-28
Primary Completion
2020-06-14
Completion
2020-06-14

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 NCT04321278 on ClinicalTrials.gov