NCT04322123

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
667

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2020

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 24, 2020

Last Update Submit

April 3, 2022

Conditions

Coronavirus Infections

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the clinical status

    Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 7 points. 1. Alive at home without limitations on activities 2. Alive at home without limitations on activities 3. In the hospital without oxygen 4. In the hospital using oxygen 5. In the hospital using high-flow nasal catheter or non-invasive ventilation 6. In hospital, on mechanical ventilation 7. Dead

    15 days after randomization

Secondary Outcomes (9)

  • Ordinal scale in 7 days

    7 days after randomization

  • Need of intubation and mechanical ventilation

    7 days after randomization

  • Use of mechanical ventilation during hospital stay

    15 days after randomization

  • Use of non-invasive ventilation

    7 days after randomization

  • Hospital Length of Stay

    28 days after randomization

  • +4 more secondary outcomes

Other Outcomes (1)

  • Safety outcome on corrected QT interval

    At day 3 and 7 after enrollment

Study Arms (3)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine after randomization, Hydroxychloroquine \[400mg 2x/day, 12/12h\] for 07 days.

Drug: Hydroxychloroquine Oral Product

Hydroxychloroquine + azithromycin

EXPERIMENTAL

Hydroxychloroquine + azithromycin. After randomization, Hydroxychloroquine \[400mg 2x/day, 12/12h\] + azithromycin \[500mg 1x/day\]) for 07 days.

Drug: Hydroxychloroquine + azithromycin

Control

NO INTERVENTION

standard treatment protocol for 2019-nCoV infection.

Interventions

Hydroxychloroquine Oral ProductDRUG

Hydroxychloroquine 400 mg BID

Hydroxychloroquine
Hydroxychloroquine + azithromycinDRUG

Hydroxychloroquine 400 mg BID + azithromycin 500 mg once a day

Hydroxychloroquine + azithromycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected or confirmed COVID-19 admitted to inpatient units and intensive care units

You may not qualify if:

  • Need for oxygen supplementation \> 4 litters per min
  • Patients using a high-flow nasal catheter
  • Patients using non-invasive mechanical ventilation
  • Patients using invasive mechanical ventilation
  • Males and females aged \< 18 years
  • Pregnancy
  • Allergy to chloroquine or derivatives
  • Allergy to azithromycin
  • Patients that have already received more than one dose of either azithromycin or hydroxychloroquine before enrollment
  • Patients with respiratory symptoms for more than 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina

Colatina, Espírito Santo, Brazil

Location

Hospital Geral Clériston Andrade

Feira de Santana, Estado de Bahia, Brazil

Location

Hospital Ana Nery - HAN/SESAB

Salvador, Estado de Bahia, Brazil

Location

HHospital SAMUR

Vitória da Conquista, Estado de Bahia, Brazil

Location

Hospital Geral de Vitória da Conquista

Vitória da Conquista, Estado de Bahia, Brazil

Location

Hospital de Brasília

Brasília, Federal District, Brazil

Location

Instituto de Cardiologia do Distrito Federal

Brasília, Federal District, Brazil

Location

Hospital Vila da Serra

Nova Lima, Minas Gerais, Brazil

Location

Santa Casa de Misericórdia de São João Del Rei

São João del Rei, Minas Gerais, Brazil

Location

Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina

Londrina, Paraná, Brazil

Location

Instituto Estadual do Cérebro Paulo Niemeyer

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Location

Hospital Santa Rita - Irmandade Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital São Francisco - Irmandade Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital São José

Criciúma, Santa Catarina, Brazil

Location

Hospital Baía Sul - Baía Sul Medical Center

Florianópolis, Santa Catarina, Brazil

Location

Hospital Nereu Ramos

Florianópolis, Santa Catarina, Brazil

Location

Centro Hospitalar Unimed

Joinville, Santa Catarina, Brazil

Location

Hospital SEPACO

São Paulo, S, Brazil

Location

Hospital de Amor - Unidade Barretos (Fundação PIO XII)

Barretos, São Paulo, Brazil

Location

Casa de Saúde Santa Marcelina

São Paulo, São Paulo, Brazil

Location

Hospital Albert Einstein

São Paulo, São Paulo, Brazil

Location

Hospital Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, São Paulo, Brazil

Location

Hospital BP Mirante - Real e Benemérita

São Paulo, São Paulo, Brazil

Location

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Location

Hospital do Servidor Público Estadual - HSPE - IAMSPE

São Paulo, São Paulo, Brazil

Location

Hospital São Paulo - UNIFESP

São Paulo, São Paulo, Brazil

Location

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

  • Furtado RHM, Barros E Silva PGM, Fonseca HAR, Serpa-Neto A, Correa TD, Guimaraes HP, Pereira AJ, Olivato GB, Zampieri FG, Lisboa T, Junqueira DLM, Lapa MG, Monfardini F, Damiani LP, Echenique LS, Gebara OE, Hoffman Filho CR, Polanczyk CA, Rohde LE, Amazonas R, Machado FR, Avezum A, Azevedo LCP, Veiga VC, Rosa RG, Lopes RD, Cavalcanti AB, Berwanger O; COALITION COVID-19 Brazil Steering Committee and Investigators. Cardiovascular Safety of Azithromycin in Patients Hospitalized With COVID-19: A Prespecified Pooled Analysis of the COALITION I and COALITION II Randomized Clinical Trials. Am J Cardiol. 2024 Mar 1;214:18-24. doi: 10.1016/j.amjcard.2023.11.069. Epub 2023 Dec 15.

    PMID: 38104755DERIVED

  • Cavalcanti AB, Zampieri FG, Rosa RG, Azevedo LCP, Veiga VC, Avezum A, Damiani LP, Marcadenti A, Kawano-Dourado L, Lisboa T, Junqueira DLM, de Barros E Silva PGM, Tramujas L, Abreu-Silva EO, Laranjeira LN, Soares AT, Echenique LS, Pereira AJ, Freitas FGR, Gebara OCE, Dantas VCS, Furtado RHM, Milan EP, Golin NA, Cardoso FF, Maia IS, Hoffmann Filho CR, Kormann APM, Amazonas RB, Bocchi de Oliveira MF, Serpa-Neto A, Falavigna M, Lopes RD, Machado FR, Berwanger O; Coalition Covid-19 Brazil I Investigators. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. N Engl J Med. 2020 Nov 19;383(21):2041-2052. doi: 10.1056/NEJMoa2019014. Epub 2020 Jul 23.

    PMID: 32706953DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

HydroxychloroquineAzithromycin

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Alexandre Biasi, PhD

    Hospital do Coração

    STUDY CHAIR

  • Otavio Berwanger

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

April 1, 2020

Primary Completion

June 2, 2020

Study Completion

June 2, 2020

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations

BR(28)