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Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection (CloroCOVID19II)

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ClinicalTrials.gov Identifier: NCT04342650
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Study Description
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Brief Summary:
This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Clinical Trial Drug: Chloroquine Diphosphate Drug: Placebo oral tablet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention
CQ 450mg twice daily (3 tablets of 150mg, every 12 hours) on day 1, followed by CQ 450mg once daily (3 tablets of 150mg) from D2 to D5. Oral administration.
 Drug: Chloroquine Diphosphate
150mg tablets
Other Name: chloroquine
Placebo Comparator: Placebo
Placebo tables of equal characteristics and duration of treatment.
 Drug: Placebo oral tablet
150mg placebo tablets


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with onset of severe acute respiratory syndrome (SARS) [ Time Frame: 7 days after randomization ]
    Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.


Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: after randomization, up to 28 days ]
    Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization

  2. Number of participants in need of intensive care support [ Time Frame: during and after intervention, up to 28 days ]
    Proportion of participants in need and duration of intensive care support after randomization

  3. Viral concentration [ Time Frame: After randomization, up to 7 days ]
    Viral load change in blood and oropharyngeal swab samples

  4. Cumulative incidence of serious adverse events [ Time Frame: During and after intervention, up to 28 days ]
    Incidence of serious adverse events during and after treatment

  5. Cumulative incidence of grade 3 and 4 adverse events [ Time Frame: During and after intervention, up to 28 days ]
    Incidence of grade 3 and 4 adverse events during and after treatment

  6. Proportion of patients with discontinued treatment [ Time Frame: after randomization, up to 28 days ]
    proportion of discontinuation or temporary suspension of treatment (for any reason)

  7. Incidence of cardiac lesions [ Time Frame: after randomization, up to 120 days ]
    proportion of patients with increased levels of troponin I

  8. Incidence of cardiac disfunctions [ Time Frame: after randomization, up to 120 days ]
    proportion and magnitude of QTcF interval increases higher than 500ms

  9. Change in respiratory capacity [ Time Frame: Day 120 after randomization ]
    Changes measured on day 120 will be compared to baseline, through spirometry.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
  2. Adult aged 18 or over, at the time of inclusion
  3. Not having severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation or supplemental oxygen, peripheral oxygen saturation> 94% in room air, and having a respiratory rate below 24 incursions per minute.
  4. Patients with comorbidities only, due to the increased risk of developing SARS

Exclusion Criteria:

1. Patients with chronic use of drugs known to prolong QTc interval.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342650


Contacts
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Contact: Marcus Lacerda, MD +55 92 99114 7633 marcuslacerda.br@gmail.com
Contact: Fernando Val, PhD +55 92 99116 3107 ffaval@gmail.com

Locations
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Brazil
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz Recruiting
Manaus, Amazonas, Brazil, 69093-415
Contact: Mayla Borba, MD    +5592981519122      
Sponsors and Collaborators
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
More Information
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Responsible Party: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
ClinicalTrials.gov Identifier: NCT04342650    
Other Study ID Numbers: CAAE: 30504220.5.0000.0005
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all patient data will be shared after study publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: after study publication
Access Criteria: Upon formal request to researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Severe Acute Respiratory Syndrome
Coronavirus Infections
Pneumonia
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Chloroquine
 Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides