Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)
Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - SEVERE - Patients
1 other identifier
interventional
440
1 country
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2020
Shorter than P25 for phase_3
58 active sites
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 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
March 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2020
CompletedJanuary 20, 2021
March 1, 2020
3 months
March 23, 2020
January 15, 2021
Conditions
Keywords
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 6 points (score ranges from 1 to 6, with 6 being the worst score)
15 days after randomization
Secondary Outcomes (9)
All-cause mortality
29 days after randomization
Evaluation of the clinical status
7 and 29 days after randomization
Number of days free from mechanical ventilation
29 days after randomization
Duration of mechanical ventilation
29 days after randomization
Duration of hospitalization
29 days after randomization
- +4 more secondary outcomes
Other Outcomes (4)
QT interval prolongation
29 days after randomization
Gastrointestinal intolerance
29 days after randomization
Laboratory abnormalities
29 days after randomization
- +1 more other outcomes
Study Arms (2)
Hydroxychloroquine + azithromycin
EXPERIMENTALHydroxychloroquine \[400mg 2x/day, 12/12h\] + azithromycin \[500mg 1x/day\]
Hydroxychloroquine
ACTIVE COMPARATORHydroxychloroquine \[400mg 2x/day, 12/12h\]
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Males and females aged \> 18 years;
- Suspected or confirmed infection by SARS-CoV2;
- Presenting with one of the following:
- Need for oxygen supplementation \> 4 L/min, or
- Need for high-flow nasal canula, or
- Need for non-invasive ventilation, or
- Need for mechanical ventilation.
You may not qualify if:
- Refusal to provide written informed consent (either the patient or a legal representative);
- Hypersensitivity to any of the drugs used in the study (Azithromycin or Hydroxychloroquine);
- Patients with more than 48 hours of prior study medication use;
- Patients with onset of symptoms longer than 14 days;
- Patients with long QT syndrome or severe ventricular arrhythmias, not protected by an implantable cardioverter defibrillators (ICD).;
- QTc\>= 480ms;
- Do not resuscitate order or exclusive palliative care;
- Patients with liver disease or cirrhosis or abnormal liver enzyme tests above three times the upper limit values (alanine aminotransferase -ALT and aspartate aminotransferase - AST);
- Patients with known retinopathy or macular degeneration;
- Patients with history of pancreatitis;
- Patients with concomitant use of medications that alter the absorption or excretion of azithromycin or hydroxychloroquine;
- Breastfeeding women;
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Israelita Albert Einsteinlead
- EMScollaborator
- Hospital do Coracaocollaborator
- Hospital Sirio-Libanescollaborator
- Brazilian Research In Intensive Care Networkcollaborator
Study Sites (58)
Hospital de Urgência e Emergência de Rio Branco
Rio Branco, Acre, Brazil
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, Ceará, Brazil
Hospital Unimed Cariri
Juazeiro do Norte, Ceará, Brazil
Hospital Estadual Jayme dos Santos Neves
Serra, Espírito Santo, Brazil
Hospital Evangélico de Vila Velha
Vila Velha, Espírito Santo, Brazil
Hospital e Clínica São Roque
Ipiaú, Estado de Bahia, Brazil
Hospital da Cidade
Salvador, Estado de Bahia, Brazil
Hospital Brasilia
Brasília, Federal District, Brazil
Secretaria de Estado de Saúde de Goias
Goiânia, Goiás, Brazil
Santa Casa de Misericórdia de Belo Horizonte Santa Casa de BH
Belo Horizonte, Minas Gerais, Brazil
Hospital Santa Paula
Passos, Minas Gerais, Brazil
Hospital Maternidade E Pronto Socorro Santa Lucia Ltda
Poços de Caldas, Minas Gerais, Brazil
Santa Casa da Misericordia - UTI (São João Del Rey)
São João del Rei, Minas Gerais, Brazil
Liga Paranaense de Combate ao Câncer
Curitiba, Paraná, Brazil
Universidade Estadual de Londrina
Londrina, Paraná, Brazil
Hospital Adventista de Belem
Belém, Pará, Brazil
Hospital Adventista de Belém
Belém, Pará, Brazil
Procape - Pronto S.Cardiologico de Pe.Prof.Luiz Tavares-
Recife, Pernambuco, Brazil
Hospital Naval Marcílio Dias
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital São Lucas
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Giselda Trigueiro
Natal, Rio Grande do Norte, Brazil
Hospital Maternidade PROMATER
Natal, Rio Grande do Norte, Brazil
Associação Dr. Bartholomeu Tacchini
Bento Gonçalves, Rio Grande do Sul, Brazil
Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Maestri E Kormann Consultoria Medico-Cientifica
Blumenau, Santa Catarina, Brazil
Sociedade Literaria e Caritativa Santo Agostinho
Criciúma, Santa Catarina, Brazil
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
Hospital Universitário Polydoro Ernani de São Thiago/HU - UFSC
Florianópolis, Santa Catarina, Brazil
Centro Hospitalar Unimed
Joinville, Santa Catarina, Brazil
Hospital Dona Helena
Joinville, Santa Catarina, Brazil
Hospital Municipal Sao Jose
Joinville, Santa Catarina, Brazil
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina, Brazil
Fundação Pio XII
Barretos, São Paulo, Brazil
Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
nstituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, Brazil
Fundação do ABC (Hospital Estadual Mário Covas)
Santo André, São Paulo, Brazil
AC Camargo Cancer Center - Fundação Antonio Prudente
São Paulo, São Paulo, Brazil
Casa de Saude Santa Marcelina
São Paulo, São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil
Hospital Moriah
São Paulo, São Paulo, Brazil
Hospital Nove de Julho
São Paulo, São Paulo, Brazil
Hospital Santa Paula
São Paulo, São Paulo, Brazil
Hospital São Camilo Pompeia
São Paulo, São Paulo, Brazil
Santa Casa de Misericordia de Votuporanga
Votuporanga, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, 05652-900, Brazil
A Beneficência Portuguesa de São Paulo - BP
São Paulo, Brazil
Associacao Beneficente Siria
São Paulo, Brazil
Hospital Vila Santa Catarina
São Paulo, Brazil
Real e Benemérita Associação Portuguesa de Beneficência/SP - 1
São Paulo, Brazil
Secretaria de Saúde do Estado de São Paulo
São Paulo, Brazil
Serv Social da Industria do papel, papelão e cortiça do estado de SP
São Paulo, Brazil
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, Brazil
Universidade Federal de São Paulo
São Paulo, Brazil
Related Publications (3)
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: 38104755DERIVEDFurtado RHM, Berwanger O, Fonseca HA, Correa TD, Ferraz LR, Lapa MG, Zampieri FG, Veiga VC, Azevedo LCP, Rosa RG, Lopes RD, Avezum A, Manoel ALO, Piza FMT, Martins PA, Lisboa TC, Pereira AJ, Olivato GB, Dantas VCS, Milan EP, Gebara OCE, Amazonas RB, Oliveira MB, Soares RVP, Moia DDF, Piano LPA, Castilho K, Momesso RGRAP, Schettino GPP, Rizzo LV, Neto AS, Machado FR, Cavalcanti AB; COALITION COVID-19 Brazil II Investigators. Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial. Lancet. 2020 Oct 3;396(10256):959-967. doi: 10.1016/S0140-6736(20)31862-6. Epub 2020 Sep 5.
PMID: 32896292DERIVEDLasheras I, Santabarbara J. Use of antimalarial drugs in the treatment of COVID-19: A window of opportunity? Med Clin (Barc). 2020 Jul 10;155(1):23-25. doi: 10.1016/j.medcli.2020.04.004. Epub 2020 Apr 22. No abstract available. English, Spanish.
PMID: 32386744DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Otávio Berwanger, PhD
Hospital Israelita Albert Einstein
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 23, 2020
First Posted
March 25, 2020
Study Start
March 28, 2020
Primary Completion
June 14, 2020
Study Completion
June 14, 2020
Last Updated
January 20, 2021
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share