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AzTrials

Coronavirus InfectionsPhase 3Coalition-INCT04322123

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

A Phase 3 study testing Hydroxychloroquine Oral Product and Hydroxychloroquine + azithromycin in people with Coronavirus Infections, run by Hospital do Coracao at 28 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Infections
What is being tested?
Hydroxychloroquine Oral Product and Hydroxychloroquine + azithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
667 participants
Where
28 sitesBrazil
Study dates
1 Apr 2020to 2 Jun 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Brazil28 sites

  • Hospital de Amor - Unidade Barretos (Fundação PIO XII)

    Barretos, São Paulo

  • Hospital de Brasília

    Brasília, Federal District

  • Instituto de Cardiologia do Distrito Federal

    Brasília, Federal District

  • Hospital Geral de Caxias do Sul

    Caxias do Sul, Rio Grande do Sul

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

    Colatina, Espírito Santo

  • Hospital São José

    Criciúma, Santa Catarina

  • Hospital Geral Clériston Andrade

    Feira de Santana, Estado de Bahia

  • Hospital Baía Sul - Baía Sul Medical Center

    Florianópolis, Santa Catarina

  • Hospital Nereu Ramos

    Florianópolis, Santa Catarina

  • Centro Hospitalar Unimed

    Joinville, Santa Catarina

  • Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina

    Londrina, Paraná

  • Hospital Vila da Serra

    Nova Lima, Minas Gerais

  • Hospital Santa Rita - Irmandade Santa Casa de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital São Francisco - Irmandade Santa Casa de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Instituto Estadual do Cérebro Paulo Niemeyer

    Rio de Janeiro, Rio de Janeiro

  • Hospital Ana Nery - HAN/SESAB

    Salvador, Estado de Bahia

  • Santa Casa de Misericórdia de São João Del Rei

    São João del Rei, Minas Gerais

  • Hospital SEPACO

    São Paulo, S

  • Casa de Saúde Santa Marcelina

    São Paulo, São Paulo

  • Hospital Albert Einstein

    São Paulo, São Paulo

  • Hospital Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, São Paulo

  • Hospital BP Mirante - Real e Benemérita

    São Paulo, São Paulo

  • Hospital das Clínicas da FMUSP

    São Paulo, São Paulo

  • Hospital do Servidor Público Estadual - HSPE - IAMSPE

    São Paulo, São Paulo

  • Hospital São Paulo - UNIFESP

    São Paulo, São Paulo

  • Hospital Sírio-Libanês

    São Paulo, São Paulo

  • HHospital SAMUR

    Vitória da Conquista, Estado de Bahia

  • Hospital Geral de Vitória da Conquista

    Vitória da Conquista, Estado de Bahia

Other trials in Brazil

About this study

Official title: An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azithromycin for COVID-19 Infection on Hospitalized, Noncritical Patients

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.

Read the detailed description

The current pandemic associated with coronavirus disease 2019 (COVID-19) represents a major global health challenge. There are no effective therapies for the management of COVID-19 that have been proven to improve clinical outcomes in this high-risk group of patients. Hydroxychloroquine and its combination with azithromycin have been suggested to improve viral clearance, but its effect on clinical outcomes remains uncertain.

This is an open-label pragmatic multicentre randomized (concealed) clinical trial of 7 days of hydroxychloroquine (400 mg BID) plus azithromycin (500 mg once daily), hydroxychloroquine 400 mg BID, or standard of care for moderately severe hospitalized patients with suspected or confirmed COVID-19 (in-patients with up to 4L/minute oxygen supply through nasal catheter). Patients are randomized in around 50 recruiting sites (630 patients with confirmed COVID-19; 1:1:1; 210 patients per arm).

The primary endpoint is a 7-level ordinal scale measured at 15-days: 1) not hospitalized, without limitations on activities; 2) not hospitalized, with limitations on activities; 3) hospitalized, not using supplementary oxygen; 4) hospitalized, using supplementary oxygen; 5) hospitalized, using high-flow nasal cannula or non-invasive ventilation; 6) hospitalized, on mechanical ventilation; 7) death. Secondary endpoints are the ordinal scale at 7 days, need for mechanical ventilation and rescue therapies during 15 days, need of high-flow nasal cannula or non-invasive ventilation during 15 days, length of hospital stay, in-hospital mortality, thromboembolic events, occurrence of acute kidney injury, defined as an increase in creatinine above 1.5 times the baseline value and number of days free of respiratory support at 15 days. Secondary safety outcomes include prolongation of QT interval on electrocardiogram, ventricular arrhythmias, and liver toxicity. The main analysis will consider all patients with confirmed COVID-19 in the groups they were randomly assigned.

Being tested
Hydroxychloroquine Oral Product, Hydroxychloroquine + azithromycin
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydroxychloroquine Oral ProductDrug

    Hydroxychloroquine 400 mg BID

  • Hydroxychloroquine + azithromycinDrug

    Hydroxychloroquine 400 mg BID + azithromycin 500 mg once a day

Study groups in NCT04322123
Study groupRoleWhat they receive
HydroxychloroquineExperimentalHydroxychloroquine after randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] for 07 days.
Receives: Drug: Hydroxychloroquine Oral Product
Hydroxychloroquine + azithromycinExperimentalHydroxychloroquine + azithromycin. After randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] + azithromycin [500mg 1x/day]) for 07 days.
Receives: Drug: Hydroxychloroquine + azithromycin
ControlNo interventionstandard treatment protocol for 2019-nCoV infection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 15 days after randomization

Secondary outcomes (9)

  1. Ordinal scale in 7 days

    Evaluation of the clinical status of patients on the 7th 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

    Measured: 7 days after randomization

  2. Need of intubation and mechanical ventilation

    Need of intubation and mechanical ventilation up to the 7th day after randomization

    Measured: 7 days after randomization

  3. Use of mechanical ventilation during hospital stay

    Use of mechanical ventilation during hospital stay

    Measured: 15 days after randomization

  4. Use of non-invasive ventilation

    Use of non-invasive ventilation up to the 7th day after randomization

    Measured: 7 days after randomization

  5. Hospital Length of Stay

    Hospital Length of Stay

    Measured: 28 days after randomization

  6. All-cause mortality

    All-cause mortality rates during hospital stay

    Measured: 28 days after randomization

  7. Thromboembolic complications

    Occurrence of thromboembolic complications such as:

    Deep vein thrombosis Pulmonary Embolism Stroke

    Measured: 15 days after randomization

  8. Acute renal disfunction

    Occurrence of renal dysfunction, defined as an increase in creatinine above 1.5 times the baseline value

    Measured: 15 days after randomization

  9. Number of days alive and free of respiratory support up to 15 days

    Number of days alive and free of respiratory support up to 15 days (DAFOR15), defined as the sum of days patients did not require supplementary oxygen, non-invasive ventilation, high-flow nasal catheter neither mechanical ventilation at 15 -days. Patients that perished during the 15-day window will receive zero DAFOR15.

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start1 Apr 2020
  3. Primary completion2 Jun 2020
  4. Study completion2 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04322123
Sponsor's protocol ID
Brazil COVID Coalition I Trial
Acronym
Coalition-I
Status last verified
Apr 2022
First submitted
24 Mar 2020
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38104755

  • 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.

    PubMed 32706953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydroxychloroquine Oral Product and Hydroxychloroquine + azithromycin in people with Coronavirus Infections, run by Hospital do Coracao at 28 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the clinical status (time frame: 15 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04322123, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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