Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)
COALITION-V
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
1 other identifier
interventional
1,372
1 country
69
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 covid19
Started May 2020
Typical duration for phase_4 covid19
69 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
Study Start
First participant enrolled
May 12, 2020
CompletedFirst Submitted
Initial submission to the registry
July 3, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2021
CompletedMarch 7, 2022
March 1, 2022
1.2 years
July 3, 2020
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
30 days from randomization
Secondary Outcomes (9)
Uncontrolled asthma after ≥ 5 days of starting study medication
within 30 days from randomization
Pneumonia
within 30 days from randomization
Otitis media
within 30 days from randomization
Fever resolution time
within 30 days from randomization
Time to improve respiratory symptoms
within 30 days from randomization
- +4 more secondary outcomes
Other Outcomes (8)
Hypoglycemia
within 30 days from randomization
Palpitations
within 30 days from randomization
Reduced visual acuity
within 30 days from randomization
- +5 more other outcomes
Study Arms (2)
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.
Placebo
PLACEBO COMPARATORThe placebo group will follow the same regimen of administration
Interventions
Hydroxychloroquine pharmaceutical form will be tablets of 400 mg.
Eligibility Criteria
You may qualify if:
- \> 65 years;
- Hypertension;
- Diabetes mellitus;
- Asthma;
- COPD or other chronic lung diseases;
- Smoking;
- Immunosuppression;
- Obesity (Defined as BMI equal to or greater than 30 Kg/m2).
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Alemão Oswaldo Cruzlead
- EMS S/Acollaborator
- Hospital do Coracaocollaborator
- Hospital Israelita Albert Einsteincollaborator
- Hospital Sirio-Libanescollaborator
- Hospital Moinhos de Ventocollaborator
- Brazilian Research In Intensive Care Networkcollaborator
Study Sites (69)
Centro de Pesquisas Clínicas Dr. Marco Mota HCOR
Maceió, Alagoas, Brazil
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
Hospital Unimed Cariri
Juazeiro do Norte, Ceará, Brazil
Unimed Sul Capixaba
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Hospital e Clínica São Roque
Ipiaú, Estado de Bahia, Brazil
Clínica Otorhinus
Salvador, Estado de Bahia, Brazil
Hospital da Bahia
Salvador, Estado de Bahia, Brazil
Hospital Santa Izabel
Salvador, Estado de Bahia, Brazil
Instituto Cárdio Pulmonar da Bahia
Salvador, Estado de Bahia, Brazil
Hospital SAMUR
Vitória da Conquista, Estado de Bahia, Brazil
Hospital das Clínicas Universidade Federal de Goiás
Goiânia, Goiás, Brazil
Santa Casa de Misericórdia de Passos
Passos, Minas Agerais, Brazil
Hospital Júlia Kubitschek
Belo Horizonte, Minas Gerais, Brazil
Instituto da Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, Minas Gerais, Brazil
Casa de Caridade de Carangola
Carangola, Minas Gerais, Brazil
Hospital Maternidade e Pronto Socorro Santa Lucia
Poços de Caldas, Minas Gerais, Brazil
Hospital da Unimed
São João del Rei, Minas Gerais, Brazil
Santa Casa de Misericórdia de São João Del Rei
São João del Rei, Minas Gerais, Brazil
Hospital de Clínicas da Universidade Federal do Triangulo Mineiro
Uberaba, Minas Gerais, Brazil
Hospital de Clínicas da Universidade Federal de Uberlândia
Uberlândia, Minas Gerais, Brazil
Hospital do Rocio
Campo Largo, Paraná, Brazil
Clínica Clinilive
Maringá, Paraná, Brazil
Hospital Universitário Regional de Maringá
Maringá, Paraná, Brazil
PROCAPE
Recife, Pernambuco, Brazil
Real Hospital Português de Beneficência em Pernambuco
Recife, Pernambuco, Brazil
SECRETARIA MUNICIPAL DE SAÚDE DE SAIRÉ (Unidade Mista Olília Mendonça Souto Maior)
Sairé, Pernambuco, Brazil
Complexo Hospitalar de Niterói
Niterói, Rio de Janeiro, Brazil
Hospital Unimed Volta Redonda
Volta Redonda, Rio de Janeiro, Brazil
Associação Dr. Bartholomeu Tacchini
Bento Gonçalves, 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
Santa Casa de Misericórdia de Porto Alegre (ISCMPA)
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Federal de Santa Maria
Santa Maria, Rio Grande do Sul, Brazil
CEPEM Centro de Pesquisa de Medicina Tropical de Rondônia
Porto Velho, Rondônia, Brazil
Irmandade de Misericórdia Do Hospital Da Santa Casa de Monte Alto
Monte Alto, Salto Alto, Brazil
Maestri e Kormann Consultoria Medico Cientifica
Blumenau, Santa Catarina, Brazil
Imigrantes Hospital e Maternidade
Brusque, Santa Catarina, Brazil
Hospital São José
Criciúma, Santa Catarina, Brazil
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina, Brazil
Santa Casa de Araras
Araras, São Paulo, Brazil
Hospital de Amor
Barretos, São Paulo, Brazil
Santa Casa de Misericórdia de Barretos
Barretos, São Paulo, Brazil
Alphacor Cardiologia Clinica E Diagnóstica LTDA
Barueri, São Paulo, Brazil
Faculdade de Medicina de Botucatu, UNESP
Botucatu, São Paulo, Brazil
Hospital Regional do Litoral Norte
Caraguatatuba, São Paulo, Brazil
Hospital de Cordeirópolis
Cordeirópolis, São Paulo, Brazil
Centro de Combate ao Coronavírus de Itapevi
Itapevi, São Paulo, Brazil
Dux Medicina
Jundiaí, São Paulo, Brazil
Hospital Carlos Fenando Malzoni
Matão, São Paulo, Brazil
Centro de Atendimento Para O Enfrentamento A Covid-19 Da Prefeitura Municipal de Monte Altoprefeitura de Monte Alto
Monte Alto, São Paulo, Brazil
Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Unimed Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Hospital Casa de Saúde de Santos
Santos, São Paulo, Brazil
Kaiser Clínica e Hospital Dia
São José do Rio Preto, São Paulo, Brazil
Hospital Policlin
São José dos Campos, São Paulo, Brazil
Hospital Regional de São José dos Campos
São José dos Campos, São Paulo, Brazil
Santa Casa de Misericórdia de Votuporanga
Votuporanga, São Paulo, Brazil
ESF Dr. João Paccola Primo
Lençois Paulista, Brazil
Cardioclinica da Ilha do Governador
Rio de Janeiro, Brazil
International Research Center - Hospital Alemão Oswaldo Cruz
São Paulo, 01323-903, Brazil
Hospital do Coração
São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
Hospital Leforte
São Paulo, Brazil
Hospital Moriah
São Paulo, Brazil
Hospital Samaritano
São Paulo, Brazil
Hospital Santa Paula
São Paulo, Brazil
Hospital São Camilo Pompéia
São Paulo, Brazil
Hospital São Paulo - UNIFESP
São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, Brazil
Related Publications (2)
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.
PMID: 35378952DERIVEDOliveira 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.
PMID: 35262569DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Álvaro Avezum, Ph.D
International Research Center - Hospital Alemão Oswaldo Cruz
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization (1:1) is generated by a validated software and performed in permuted blocks of size 8. Concealment of the randomization list is maintained through a 24-hour, centralized, automated, internet-based randomization system. Furthermore, as placebo-controlled study, the placebo will have the same structural characteristics as the active drug and will be dispensed in cartridges that do not allow the identification of what is being given
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Manager - International Research Center
Study Record Dates
First Submitted
July 3, 2020
First Posted
July 10, 2020
Study Start
May 12, 2020
Primary Completion
July 28, 2021
Study Completion
September 28, 2021
Last Updated
March 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share