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

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado (Other)
Overall Status
Completed ID

Study Details

Study Description

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
  • Drug: Chloroquine Diphosphate
  • Drug: Placebo oral tablet
Phase 2

Study Design

Study Type:
Actual Enrollment :
152 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
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 :
Apr 8, 2020
Actual Primary Completion Date :
May 14, 2020
Actual Study Completion Date :
Jun 8, 2020

Arms and Interventions

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 Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the refers to chloroquine base (in mg).
Other Names:
  • chloroquine
  • Placebo Comparator: Placebo

    Placebo tables of equal characteristics and duration of treatment.

    Drug: Placebo oral tablet
    150mg placebo tablets

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with onset of severe acute respiratory syndrome (SARS) [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 [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 [during and after intervention, up to 28 days]

      Proportion of participants in need and duration of intensive care support after randomization

    3. Viral concentration [After randomization, up to 7 days]

      Viral load change in blood and oropharyngeal swab samples

    4. Cumulative incidence of serious adverse events [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 [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 [after randomization, up to 28 days]

      proportion of discontinuation or temporary suspension of treatment (for any reason)

    7. Incidence of cardiac lesions [after randomization, up to 120 days]

      proportion of patients with increased levels of troponin I

    8. Incidence of cardiac disfunctions [after randomization, up to 120 days]

      proportion and magnitude of QTcF interval increases higher than 500ms

    9. Change in respiratory capacity [Day 120 after randomization]

      Changes measured on day 120 will be compared to baseline, through spirometry.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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


    Site City State Country Postal Code
    1 Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz Manaus Amazonas Brazil 69093-415

    Sponsors and Collaborators

    • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Fundação de Medicina Tropical Dr. Heitor Vieira Dourado Identifier:
    Other Study ID Numbers:
    • CAAE: 30504220.5.0000.0005
    First Posted:
    Apr 13, 2020
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2021