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COVID-19Phase 4COALITION-VNCT04466540

Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)

A Phase 4 study testing Hydroxychloroquine in people with COVID-19, run by Hospital Alemão Oswaldo Cruz at 69 sites in Brazil.

Completed

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

Official record
Search all trials

Trial summary

In December 2019, a group of patients with pneumonia of unknown cause was identified in Wuhan, in the Hubei province, China. Despite the need of target specific therapeutic options for COVID-19, until now there is no proof of effectiveness of any specific intervention. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Hydroxychloroquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,372 participants
Where
69 sitesBrazil
Study dates
12 May 2020to 28 Sep 2021
Phase
Phase 4
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

  • It will be considered eligible those adults (equal to or greater than 18 years) seeking medical care with suspected or confirmed COVID-19, with time between symptoms and inclusion ≤ 07 days, presenting mild symptoms, without indication of hospitalization and at least 1 risk factor for complication:
  • > 65 years;
  • Hypertension;
  • Diabetes mellitus;
  • Asthma;
  • COPD or other chronic lung diseases;
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  • Smoking;
  • Immunosuppression;
  • Obesity (Defined as BMI equal to or greater than 30 Kg/m2).

Who cannot join

  • Patients under 18 years old;
  • Hospitalization at the first medical care;
  • Positive test for influenza at the first medical care;
  • Known hypersensitivity to hydroxychloroquine / chloroquine;
  • Previous diagnosis of retinopathy or macular degeneration;
  • Previous diagnosis of Long QT-syndrome, history of sudden death in close family members (parents and siblings), decompensated heart failure, unstable coronary artery disease, use of anti-arrhythmic drugs or other drugs that can increase the hydroxychloroquine bioavailability or enhance its effect;
Show all 12Show fewer
  • Evidence of known liver disease, reported by the patient;
  • Evidence of known chronic kidney disease, reported by the patient;
  • Patients with pancreatitis;
  • Baseline ECG with QTc interval ≥ 480ms;
  • Chronic use of hydroxychloroquine/chloroquine for other reasons;
  • Pregnancy.

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

Brazil69 sites

  • Santa Casa de Araras

    Araras, São Paulo

  • Hospital Maternidade São Vicente de Paulo

    Barbalha, Ceará

  • Hospital de Amor

    Barretos, São Paulo

  • Santa Casa de Misericórdia de Barretos

    Barretos, São Paulo

  • Alphacor Cardiologia Clinica E Diagnóstica LTDA

    Barueri, São Paulo

  • Hospital Júlia Kubitschek

    Belo Horizonte, Minas Gerais

  • Instituto da Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

    Belo Horizonte, Minas Gerais

  • Associação Dr. Bartholomeu Tacchini

    Bento Gonçalves, Rio Grande do Sul

  • Maestri e Kormann Consultoria Medico Cientifica

    Blumenau, Santa Catarina

  • Faculdade de Medicina de Botucatu, UNESP

    Botucatu, São Paulo

  • Imigrantes Hospital e Maternidade

    Brusque, Santa Catarina

  • Unimed Sul Capixaba

    Cachoeiro de Itapemirim, Espírito Santo

  • Hospital do Rocio

    Campo Largo, Paraná

  • Hospital Regional do Litoral Norte

    Caraguatatuba, São Paulo

  • Casa de Caridade de Carangola

    Carangola, Minas Gerais

  • Hospital de Cordeirópolis

    Cordeirópolis, São Paulo

  • Hospital São José

    Criciúma, Santa Catarina

  • Hospital das Clínicas Universidade Federal de Goiás

    Goiânia, Goiás

  • Hospital e Clínica São Roque

    Ipiaú, Estado de Bahia

  • Centro de Combate ao Coronavírus de Itapevi

    Itapevi, São Paulo

  • Hospital Regional Hans Dieter Schmidt

    Joinville, Santa Catarina

  • Hospital Unimed Cariri

    Juazeiro do Norte, Ceará

  • Dux Medicina

    Jundiaí, São Paulo

  • ESF Dr. João Paccola Primo

    Lençois Paulista

  • Centro de Pesquisas Clínicas Dr. Marco Mota HCOR

    Maceió, Alagoas

  • Clínica Clinilive

    Maringá, Paraná

  • Hospital Universitário Regional de Maringá

    Maringá, Paraná

  • Hospital Carlos Fenando Malzoni

    Matão, São Paulo

  • Irmandade de Misericórdia Do Hospital Da Santa Casa de Monte Alto

    Monte Alto, Salto Alto

  • Centro de Atendimento Para O Enfrentamento A Covid-19 Da Prefeitura Municipal de Monte Altoprefeitura de Monte Alto

    Monte Alto, São Paulo

  • Complexo Hospitalar de Niterói

    Niterói, Rio de Janeiro

  • Hospital São Vicente de Paulo

    Passo Fundo, Rio Grande do Sul

  • Santa Casa de Misericórdia de Passos

    Passos, Minas Agerais

  • Hospital Maternidade e Pronto Socorro Santa Lucia

    Poços de Caldas, Minas Gerais

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul

  • Santa Casa de Misericórdia de Porto Alegre (ISCMPA)

    Porto Alegre, Rio Grande do Sul

  • CEPEM Centro de Pesquisa de Medicina Tropical de Rondônia

    Porto Velho, Rondônia

  • PROCAPE

    Recife, Pernambuco

  • Real Hospital Português de Beneficência em Pernambuco

    Recife, Pernambuco

  • Faculdade de Medicina de Ribeirão Preto

    Ribeirão Preto, São Paulo

  • Unimed Ribeirão Preto

    Ribeirão Preto, São Paulo

  • Cardioclinica da Ilha do Governador

    Rio de Janeiro

  • SECRETARIA MUNICIPAL DE SAÚDE DE SAIRÉ (Unidade Mista Olília Mendonça Souto Maior)

    Sairé, Pernambuco

  • Clínica Otorhinus

    Salvador, Estado de Bahia

  • Hospital da Bahia

    Salvador, Estado de Bahia

  • Hospital Santa Izabel

    Salvador, Estado de Bahia

  • Instituto Cárdio Pulmonar da Bahia

    Salvador, Estado de Bahia

  • Universidade Federal de Santa Maria

    Santa Maria, Rio Grande do Sul

  • Hospital Casa de Saúde de Santos

    Santos, São Paulo

  • Hospital da Unimed

    São João del Rei, Minas Gerais

  • Santa Casa de Misericórdia de São João Del Rei

    São João del Rei, Minas Gerais

  • Kaiser Clínica e Hospital Dia

    São José do Rio Preto, São Paulo

  • Hospital Policlin

    São José dos Campos, São Paulo

  • Hospital Regional de São José dos Campos

    São José dos Campos, São Paulo

  • International Research Center - Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-903

  • Hospital do Coração

    São Paulo

  • Hospital Israelita Albert Einstein

    São Paulo

  • Hospital Leforte

    São Paulo

  • Hospital Moriah

    São Paulo

  • Hospital Samaritano

    São Paulo

  • Hospital Santa Paula

    São Paulo

  • Hospital São Camilo Pompéia

    São Paulo

  • Hospital São Paulo - UNIFESP

    São Paulo

  • Hospital Sírio-Libanês

    São Paulo

  • Hospital de Clínicas da Universidade Federal do Triangulo Mineiro

    Uberaba, Minas Gerais

  • Hospital de Clínicas da Universidade Federal de Uberlândia

    Uberlândia, Minas Gerais

  • Hospital SAMUR

    Vitória da Conquista, Estado de Bahia

  • Hospital Unimed Volta Redonda

    Volta Redonda, Rio de Janeiro

  • Santa Casa de Misericórdia de Votuporanga

    Votuporanga, São Paulo

Other trials in Brazil

About this study

Official title: Pragmatic, Double-blind, Placebo-controlled Randomized Clinical Trial, Evaluating Hydroxychloroquine for Prevention of Hospitalization and Respiratory Complications in Non-hospitalized Patients With Confirmed or Probable COVID-19

In December 2019, a group of patients with pneumonia of unknown cause was identified in Wuhan, in the Hubei province, China. Despite the need of target specific therapeutic options for COVID-19, until now there is no proof of effectiveness of any specific intervention. Some limited observational trials and also evidence from randomized trials have shown no benefit of hydroxychloroquine in inpatient context. Thus, studies evaluating interventions in an outpatient setting in non-severe patients can provide important information related to prognosis and safety. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine in COVID-19 outpatients by means of a Randomized, double-blind, placebo-controlled trial

Read the detailed description

Pragmatic, double-blind, placebo-controlled randomized parallel-group, two-arm clinical trial (with allocation ratio 1:1), evaluating hydroxychloroquine (800 mg at 1st day, and 400 mg from day 2 to 7) for prevention of hospitalization and respiratory complications in non-hospitalized confirmed or suspected COVID-19 cases. Key inclusion criteria are adults (equal to or greater tahn 18 years) seeking medical care with suspected or confirmed COVID-19, with time between symptoms and inclusion ≤ 07 days, presenting mild symptoms, without indication of hospitalization and at least one risk factor for complication (> 65 years; hypertension; diabetes mellitus; asthma; Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung diseases; smoking; immunosuppression; obesity (Defined as BMI equal to or greater than 30 Kg/m2). Primary endpoint is to assess if the treatment with hydroxychloroquine is able to avoid hospitalization due to a COVID-19-related clinical reason within 30 days of randomization in an outpatient setting. Hospitalization is considered to be hospital stay for a period > 24h or an additional hospitalized calendar day. The primary endpoint is centrally adjudicated by an independent clinical events committee blinded to the assigned treatment groups. Secondary endpoints include uncontrolled asthma after ≥ 5 days of starting study medication; pneumonia; otitis media; fever resolution time; time to improve respiratory symptoms; hospitalization in the Intensive Care Unit; need for orotracheal intubation; mechanical ventilation time; mortality. Safety outcomes will be hypoglycemia; palpitations; reduced visual acuity; diarrhea; anorexia; and emotional lability. The evaluation of the primary outcome (hospitalization within 30 days) will be performed for the included population following the principle of intention-to-treat (ITT), which will consist of all randomized cases. A modified intention-to-treat analysis (mITT), in which cases definitely confirmed as negative for COVID-19 will be excluded, will also be performed.

Conditions
COVID-19
Being tested
Hydroxychloroquine, Placebo
Keywords
COVID-19, Severe Acute Respiratory Syndrome - Coronavirus-2, Hydroxychloroquine, COALITION Brazil V 2019, Outpatients
Medical subject headings
COVID-19

What participants receive

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

  • HydroxychloroquineDrug

    Hydroxychloroquine pharmaceutical form will be tablets of 400 mg.

  • PlaceboDrug

    Hydroxychloroquine placebo

Study groups in NCT04466540
Study groupRoleWhat they receive
Hydroxychloroquine (HCQ)ExperimentalHCQ group participants will receive a dose of 400mg twice daily (BID) in the first day, and a dose of 400 mg once daily (OD) from the second day of treatment, in a total of 7 days.
Receives: Drug: Hydroxychloroquine
PlaceboPlacebo comparatorThe placebo group will follow the same regimen of administration
Receives: Drug: Placebo

What is being measured

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

  1. Hospitalization

    To assess if the treatment is able to avoid hospitalization due to a COVID-19-related clinical reason within 30 days of randomization in an outpatient setting. Hospitalization is considered to be hospital stay for a period > 24h or an additional hospitalized calendar day.

    Measured: 30 days from randomization

Secondary outcomes (9)

  1. Uncontrolled asthma after ≥ 5 days of starting study medication

    Affirmative answer in three or four items of the Global Initiative for Asthma (GINA) questionnaire

    Measured: within 30 days from randomization

  2. Pneumonia

    Defined by clinical-radiological criteria - a history of cough and one or more of the following symptoms: sputum, dyspnea, chest pain, sweating or fever (T> 37.8o C) + Chest CT scan showing ground-glass opacity, focal consolidations or mixed opacities (including reverse halo sign), uni or bilateral

    Measured: within 30 days from randomization

  3. Otitis media

    Defined by clinical criteria - Fever (T> 37.8o C) and otalgia + bulging of the tympanic membrane

    Measured: within 30 days from randomization

  4. Fever resolution time

    Day 0 of fever resolution will be defined as the first afebrile day (T <37.5o C) after inclusion in the study followed by at least two consecutive days. The temperature will be obtained through the participant report in the patient's diary

    Measured: within 30 days from randomization

  5. Time to improve respiratory symptoms

    Time to improve respiratory symptoms (cough, runny nose)

    Measured: within 30 days from randomization

  6. Hospitalization in the Intensive Care Unit

    Admission to ICU due to clinical reasons related to COVID-19

    Measured: within 30 days from randomization

  7. Need for Orotracheal Intubation

    Clinical need for Orotracheal Intubation as assessed by the physician responsible for the case

    Measured: within 30 days from randomization

  8. Mechanical Ventilation Time

    Number of days on mechanical ventilation until extubation or death

    Measured: within 30 days from randomization

  9. Mortality

    Death due to any cause that occurred within 30 days after inclusion in the study

    Measured: within 30 days from randomization

Timeline

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

  1. First posted10 Jul 2020
  2. Study start12 May 2020
  3. Primary completion28 Jul 2021
  4. Study completion28 Sep 2021

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic, double-blind, placebo-controlled randomized parallel-group, two-arm clinical trial (with allocation ratio 1:1)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04466540
Sponsor's protocol ID
30415320.8.1001.0070
Acronym
COALITION-V
Status last verified
Mar 2022
First submitted
3 Jul 2020
Last updated
7 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Avezum A, Oliveira GBF, Oliveira H, Lucchetta RC, Pereira VFA, Dabarian AL, D O Vieira R, Silva DV, Kormann APM, Tognon AP, De Gasperi R, Hernandes ME, Feitosa ADM, Piscopo A, Souza AS, Miguel CH, Nogueira VO, Minelli C, Magalhaes CC, Morejon KML, Bicudo LS, Souza GEC, Gomes MAM, Fo JJFR, Schwarzbold AV, Zilli A, Amazonas RB, Moreira FR, Alves LBO, Assis SRL, Neves PDMM, Matuoka JY, Boszczowski I, Catarino DGM, Veiga VC, Azevedo LCP, Rosa RG, Lopes RD, Cavalcanti AB, Berwanger O; COPE - COALITION COVID-19 Brazil V Investigators. Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE - Coalition V): A double-blind, multicentre, randomised, controlled trial. Lancet Reg Health Am. 2022 Jul;11:100243. doi: 10.1016/j.lana.2022.100243. Epub 2022 Mar 31.

    PubMed 35378952

  • Oliveira Junior HA, Ferri CP, Boszczowski I, Oliveira GBF, Cavalcanti AB, Rosa RG, Lopes RD, Azevedo LCP, Veiga VC, Berwanger O, Avezum A. Rationale and Design of the COVID-19 Outpatient Prevention Evaluation (COPE - Coalition V) Randomized Clinical Trial: Hydroxychloroquine vs. Placebo in Non-Hospitalized Patients. Arq Bras Cardiol. 2022 Feb;118(2):378-387. doi: 10.36660/abc.20210832. English, Portuguese.

    PubMed 35262569

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hydroxychloroquine in people with COVID-19, run by Hospital Alemão Oswaldo Cruz at 69 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 9 inclusion and 12 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 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Hospitalization (time frame: 30 days from 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 NCT04466540, 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 7 Mar 2022.

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