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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342650
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Tracking Information
First Submitted Date  ICMJE April 4, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE April 8, 2020
Actual Primary Completion Date May 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • 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
  • 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
  • Viral concentration [ Time Frame: After randomization, up to 7 days ]
    Viral load change in blood and oropharyngeal swab samples
  • 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
  • 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
  • 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)
  • Incidence of cardiac lesions [ Time Frame: after randomization, up to 120 days ]
    proportion of patients with increased levels of troponin I
  • Incidence of cardiac disfunctions [ Time Frame: after randomization, up to 120 days ]
    proportion and magnitude of QTcF interval increases higher than 500ms
  • Change in respiratory capacity [ Time Frame: Day 120 after randomization ]
    Changes measured on day 120 will be compared to baseline, through spirometry.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • SARS-CoV Infection
  • Severe Acute Respiratory Syndrome (SARS) Pneumonia
  • Clinical Trial
Intervention  ICMJE
  • Drug: Chloroquine Diphosphate
    150mg tablets
    Other Name: chloroquine
  • Drug: Placebo oral tablet
    150mg placebo tablets
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Chloroquine Diphosphate
  • Placebo Comparator: Placebo
    Placebo tables of equal characteristics and duration of treatment.
    Intervention: Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2020)
152
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2020)
210
Actual Study Completion Date  ICMJE June 8, 2020
Actual Primary Completion Date May 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04342650
Other Study ID Numbers  ICMJE CAAE: 30504220.5.0000.0005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all patient data will be shared after study publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: after study publication
Access Criteria: Upon formal request to researchers.
Responsible Party Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Study Sponsor  ICMJE Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP