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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
Hospital Alemão Oswaldo Cruz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Severe Acute Respiratory Syndrome - Coronavirus-2, Hydroxychloroquine, COALITION Brazil V 2019, Outpatients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:

  1. > 65 years;
  2. Hypertension;
  3. Diabetes mellitus;
  4. Asthma;
  5. COPD or other chronic lung diseases;
  6. Smoking;
  7. Immunosuppression;
  8. Obesity (Defined as BMI equal to or greater than 30 Kg/m2).

Exclusion Criteria:

  1. Patients under 18 years old;
  2. Hospitalization at the first medical care;
  3. Positive test for influenza at the first medical care;
  4. Known hypersensitivity to hydroxychloroquine / chloroquine;
  5. Previous diagnosis of retinopathy or macular degeneration;
  6. 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;
  7. Evidence of known liver disease, reported by the patient;
  8. Evidence of known chronic kidney disease, reported by the patient;
  9. Patients with pancreatitis;
  10. Baseline ECG with QTc interval ≥ 480ms;
  11. Chronic use of hydroxychloroquine/chloroquine for other reasons;
  12. Pregnancy.

Sites / Locations

  • Centro de Pesquisas Clínicas Dr. Marco Mota HCOR
  • Hospital e Clínica São Roque
  • Clínica Otorhinus
  • Hospital da Bahia
  • Hospital Santa Izabel
  • Instituto Cárdio Pulmonar da Bahia
  • Hospital SAMUR
  • Hospital Maternidade São Vicente de Paulo
  • Hospital Unimed Cariri
  • Unimed Sul Capixaba
  • Hospital das Clínicas Universidade Federal de Goiás
  • Santa Casa de Misericórdia de Passos
  • Hospital Júlia Kubitschek
  • Instituto da Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
  • Casa de Caridade de Carangola
  • Hospital Maternidade e Pronto Socorro Santa Lucia
  • Hospital da Unimed
  • Santa Casa de Misericórdia de São João Del Rei
  • Hospital de Clínicas da Universidade Federal do Triangulo Mineiro
  • Hospital de Clínicas da Universidade Federal de Uberlândia
  • Hospital do Rocio
  • Clínica Clinilive
  • Hospital Universitário Regional de Maringá
  • PROCAPE
  • Real Hospital Português de Beneficência em Pernambuco
  • SECRETARIA MUNICIPAL DE SAÚDE DE SAIRÉ (Unidade Mista Olília Mendonça Souto Maior)
  • Complexo Hospitalar de Niterói
  • Hospital Unimed Volta Redonda
  • Associação Dr. Bartholomeu Tacchini
  • Hospital São Vicente de Paulo
  • Hospital Moinhos de Vento
  • Santa Casa de Misericórdia de Porto Alegre (ISCMPA)
  • Universidade Federal de Santa Maria
  • CEPEM Centro de Pesquisa de Medicina Tropical de Rondônia
  • Irmandade de Misericórdia Do Hospital Da Santa Casa de Monte Alto
  • Maestri e Kormann Consultoria Medico Cientifica
  • Imigrantes Hospital e Maternidade
  • Hospital São José
  • Hospital Regional Hans Dieter Schmidt
  • Santa Casa de Araras
  • Hospital de Amor
  • Santa Casa de Misericórdia de Barretos
  • Alphacor Cardiologia Clinica E Diagnóstica LTDA
  • Faculdade de Medicina de Botucatu, UNESP
  • Hospital Regional do Litoral Norte
  • Hospital de Cordeirópolis
  • Centro de Combate ao Coronavírus de Itapevi
  • Dux Medicina
  • Hospital Carlos Fenando Malzoni
  • Centro de Atendimento Para O Enfrentamento A Covid-19 Da Prefeitura Municipal de Monte Altoprefeitura de Monte Alto
  • Faculdade de Medicina de Ribeirão Preto
  • Unimed Ribeirão Preto
  • Hospital Casa de Saúde de Santos
  • Kaiser Clínica e Hospital Dia
  • Hospital Policlin
  • Hospital Regional de São José dos Campos
  • Santa Casa de Misericórdia de Votuporanga
  • ESF Dr. João Paccola Primo
  • Cardioclinica da Ilha do Governador
  • International Research Center - Hospital Alemão Oswaldo Cruz
  • Hospital do Coração
  • Hospital Israelita Albert Einstein
  • Hospital Leforte
  • Hospital Moriah
  • Hospital Samaritano
  • Hospital Santa Paula
  • Hospital São Camilo Pompéia
  • Hospital São Paulo - UNIFESP
  • Hospital Sírio-Libanês

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxychloroquine (HCQ)

Placebo

Arm Description

HCQ 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.

The placebo group will follow the same regimen of administration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Uncontrolled asthma after ≥ 5 days of starting study medication
Affirmative answer in three or four items of the Global Initiative for Asthma (GINA) questionnaire
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
Otitis media
Defined by clinical criteria - Fever (T> 37.8o C) and otalgia + bulging of the tympanic membrane
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
Time to improve respiratory symptoms
Time to improve respiratory symptoms (cough, runny nose)
Hospitalization in the Intensive Care Unit
Admission to ICU due to clinical reasons related to COVID-19
Need for Orotracheal Intubation
Clinical need for Orotracheal Intubation as assessed by the physician responsible for the case
Mechanical Ventilation Time
Number of days on mechanical ventilation until extubation or death
Mortality
Death due to any cause that occurred within 30 days after inclusion in the study

Full Information

First Posted
July 3, 2020
Last Updated
March 4, 2022
Sponsor
Hospital Alemão Oswaldo Cruz
Collaborators
EMS S/A, Hospital do Coracao, Hospital Israelita Albert Einstein, Hospital Sirio-Libanes, Hospital Moinhos de Vento, Brazilian Research In Intensive Care Network
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1. Study Identification

Unique Protocol Identification Number
NCT04466540
Brief Title
Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)
Acronym
COALITION-V
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Alemão Oswaldo Cruz
Collaborators
EMS S/A, Hospital do Coracao, Hospital Israelita Albert Einstein, Hospital Sirio-Libanes, Hospital Moinhos de Vento, Brazilian Research In Intensive Care Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Severe Acute Respiratory Syndrome - Coronavirus-2, Hydroxychloroquine, COALITION Brazil V 2019, Outpatients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic, double-blind, placebo-controlled randomized parallel-group, two-arm clinical trial (with allocation ratio 1:1)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
1372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine (HCQ)
Arm Type
Experimental
Arm Description
HCQ 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group will follow the same regimen of administration
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine pharmaceutical form will be tablets of 400 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Hydroxychloroquine placebo
Primary Outcome Measure Information:
Title
Hospitalization
Description
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.
Time Frame
30 days from randomization
Secondary Outcome Measure Information:
Title
Uncontrolled asthma after ≥ 5 days of starting study medication
Description
Affirmative answer in three or four items of the Global Initiative for Asthma (GINA) questionnaire
Time Frame
within 30 days from randomization
Title
Pneumonia
Description
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
Time Frame
within 30 days from randomization
Title
Otitis media
Description
Defined by clinical criteria - Fever (T> 37.8o C) and otalgia + bulging of the tympanic membrane
Time Frame
within 30 days from randomization
Title
Fever resolution time
Description
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
Time Frame
within 30 days from randomization
Title
Time to improve respiratory symptoms
Description
Time to improve respiratory symptoms (cough, runny nose)
Time Frame
within 30 days from randomization
Title
Hospitalization in the Intensive Care Unit
Description
Admission to ICU due to clinical reasons related to COVID-19
Time Frame
within 30 days from randomization
Title
Need for Orotracheal Intubation
Description
Clinical need for Orotracheal Intubation as assessed by the physician responsible for the case
Time Frame
within 30 days from randomization
Title
Mechanical Ventilation Time
Description
Number of days on mechanical ventilation until extubation or death
Time Frame
within 30 days from randomization
Title
Mortality
Description
Death due to any cause that occurred within 30 days after inclusion in the study
Time Frame
within 30 days from randomization
Other Pre-specified Outcome Measures:
Title
Hypoglycemia
Description
Change in the frequency of hypoglycemic episodes in diabetic patients using hypoglycemic medication, perceived by clinical signs or symptoms or measured in a capillary or blood glucose device
Time Frame
within 30 days from randomization
Title
Palpitations
Description
Presence of cardiac arrhythmias in patients without known history of prolongation of the measure between Q wave and T wave in the heart's electrical cycle (QTc) or pre-existing heart disease;
Time Frame
within 30 days from randomization
Title
Reduced visual acuity
Description
Change in visual acuity or new diagnosis of retinal disease not previously documented
Time Frame
within 30 days from randomization
Title
Diarrhea
Description
Change in bowel habit greater than three (3) diarrheal episodes per day during the use of hydroxychloroquine medication and 3 days after its end
Time Frame
within 30 days from randomization
Title
Anorexia
Description
Change in appetite during medication use hydroxychloroquine and 3 days after the end of treatment
Time Frame
within 30 days from randomization
Title
Emotional lability
Description
Perception of change in emotional lability (mood swings) during hydroxychloroquine use and 3 days after the end of treatment
Time Frame
within 30 days from randomization
Title
Time to hospitalization after randomization
Description
Time from randomization to hospitalization
Time Frame
within 30 days from randomization
Title
Assessment of the patient clinical status at the time of hospitalization
Description
Clinical and vital signs assessed when admitted to hospital
Time Frame
within 30 days from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Smoking; Immunosuppression; Obesity (Defined as BMI equal to or greater than 30 Kg/m2). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Álvaro Avezum, Ph.D
Organizational Affiliation
International Research Center - Hospital Alemão Oswaldo Cruz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisas Clínicas Dr. Marco Mota HCOR
City
Maceió
State/Province
Alagoas
Country
Brazil
Facility Name
Hospital e Clínica São Roque
City
Ipiaú
State/Province
Bahia
Country
Brazil
Facility Name
Clínica Otorhinus
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Hospital da Bahia
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Hospital Santa Izabel
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Instituto Cárdio Pulmonar da Bahia
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Hospital SAMUR
City
Vitória Da Conquista
State/Province
Bahia
Country
Brazil
Facility Name
Hospital Maternidade São Vicente de Paulo
City
Barbalha
State/Province
Ceará
Country
Brazil
Facility Name
Hospital Unimed Cariri
City
Juazeiro Do Norte
State/Province
Ceará
Country
Brazil
Facility Name
Unimed Sul Capixaba
City
Cachoeiro De Itapemirim
State/Province
Espírito Santo
Country
Brazil
Facility Name
Hospital das Clínicas Universidade Federal de Goiás
City
Goiânia
State/Province
Goiás
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Passos
City
Passos
State/Province
Minas Agerais
Country
Brazil
Facility Name
Hospital Júlia Kubitschek
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Instituto da Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Casa de Caridade de Carangola
City
Carangola
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital Maternidade e Pronto Socorro Santa Lucia
City
Poços De Caldas
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital da Unimed
City
São João Del Rei
State/Province
Minas Gerais
Country
Brazil
Facility Name
Santa Casa de Misericórdia de São João Del Rei
City
São João Del Rei
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital de Clínicas da Universidade Federal do Triangulo Mineiro
City
Uberaba
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital de Clínicas da Universidade Federal de Uberlândia
City
Uberlândia
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital do Rocio
City
Campo Largo
State/Province
Paraná
Country
Brazil
Facility Name
Clínica Clinilive
City
Maringá
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Universitário Regional de Maringá
City
Maringá
State/Province
Paraná
Country
Brazil
Facility Name
PROCAPE
City
Recife
State/Province
Pernambuco
Country
Brazil
Facility Name
Real Hospital Português de Beneficência em Pernambuco
City
Recife
State/Province
Pernambuco
Country
Brazil
Facility Name
SECRETARIA MUNICIPAL DE SAÚDE DE SAIRÉ (Unidade Mista Olília Mendonça Souto Maior)
City
Sairé
State/Province
Pernambuco
Country
Brazil
Facility Name
Complexo Hospitalar de Niterói
City
Niterói
State/Province
Rio De Janeiro
Country
Brazil
Facility Name
Hospital Unimed Volta Redonda
City
Volta Redonda
State/Province
Rio De Janeiro
Country
Brazil
Facility Name
Associação Dr. Bartholomeu Tacchini
City
Bento Gonçalves
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital São Vicente de Paulo
City
Passo Fundo
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Porto Alegre (ISCMPA)
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Universidade Federal de Santa Maria
City
Santa Maria
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
CEPEM Centro de Pesquisa de Medicina Tropical de Rondônia
City
Porto Velho
State/Province
Rondônia
Country
Brazil
Facility Name
Irmandade de Misericórdia Do Hospital Da Santa Casa de Monte Alto
City
Monte alto
State/Province
Salto Alto
Country
Brazil
Facility Name
Maestri e Kormann Consultoria Medico Cientifica
City
Blumenau
State/Province
Santa Catarina
Country
Brazil
Facility Name
Imigrantes Hospital e Maternidade
City
Brusque
State/Province
Santa Catarina
Country
Brazil
Facility Name
Hospital São José
City
Criciúma
State/Province
Santa Catarina
Country
Brazil
Facility Name
Hospital Regional Hans Dieter Schmidt
City
Joinville
State/Province
Santa Catarina
Country
Brazil
Facility Name
Santa Casa de Araras
City
Araras
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital de Amor
City
Barretos
State/Province
São Paulo
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Barretos
City
Barretos
State/Province
São Paulo
Country
Brazil
Facility Name
Alphacor Cardiologia Clinica E Diagnóstica LTDA
City
Barueri
State/Province
São Paulo
Country
Brazil
Facility Name
Faculdade de Medicina de Botucatu, UNESP
City
Botucatu
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Regional do Litoral Norte
City
Caraguatatuba
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital de Cordeirópolis
City
Cordeirópolis
State/Province
São Paulo
Country
Brazil
Facility Name
Centro de Combate ao Coronavírus de Itapevi
City
Itapevi
State/Province
São Paulo
Country
Brazil
Facility Name
Dux Medicina
City
Jundiaí
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Carlos Fenando Malzoni
City
Matão
State/Province
São Paulo
Country
Brazil
Facility Name
Centro de Atendimento Para O Enfrentamento A Covid-19 Da Prefeitura Municipal de Monte Altoprefeitura de Monte Alto
City
Monte alto
State/Province
São Paulo
Country
Brazil
Facility Name
Faculdade de Medicina de Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Unimed Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Casa de Saúde de Santos
City
Santos
State/Province
São Paulo
Country
Brazil
Facility Name
Kaiser Clínica e Hospital Dia
City
São José Do Rio Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Policlin
City
São José Dos Campos
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Regional de São José dos Campos
City
São José Dos Campos
State/Province
São Paulo
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Votuporanga
City
Votuporanga
State/Province
São Paulo
Country
Brazil
Facility Name
ESF Dr. João Paccola Primo
City
Lençois Paulista
Country
Brazil
Facility Name
Cardioclinica da Ilha do Governador
City
Rio De Janeiro
Country
Brazil
Facility Name
International Research Center - Hospital Alemão Oswaldo Cruz
City
São Paulo
ZIP/Postal Code
01323-903
Country
Brazil
Facility Name
Hospital do Coração
City
São Paulo
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
Country
Brazil
Facility Name
Hospital Leforte
City
São Paulo
Country
Brazil
Facility Name
Hospital Moriah
City
São Paulo
Country
Brazil
Facility Name
Hospital Samaritano
City
São Paulo
Country
Brazil
Facility Name
Hospital Santa Paula
City
São Paulo
Country
Brazil
Facility Name
Hospital São Camilo Pompéia
City
São Paulo
Country
Brazil
Facility Name
Hospital São Paulo - UNIFESP
City
São Paulo
Country
Brazil
Facility Name
Hospital Sírio-Libanês
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35378952
Citation
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.
Results Reference
derived
PubMed Identifier
35262569
Citation
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.
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Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)

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