Back to resultsChloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection (CloroCOVID19II)
Primary Purpose
COVID-19, SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Chloroquine Diphosphate
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
- Adult aged 18 or over, at the time of inclusion
- 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.
- 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.
Sites / Locations
- Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
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.
Placebo tables of equal characteristics and duration of treatment.
Outcomes
Primary Outcome Measures
Proportion of patients with onset of severe acute respiratory syndrome (SARS)
Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
Secondary Outcome Measures
Mortality rate
Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization
Number of participants in need of intensive care support
Proportion of participants in need and duration of intensive care support after randomization
Viral concentration
Viral load change in blood and oropharyngeal swab samples
Cumulative incidence of serious adverse events
Incidence of serious adverse events during and after treatment
Cumulative incidence of grade 3 and 4 adverse events
Incidence of grade 3 and 4 adverse events during and after treatment
Proportion of patients with discontinued treatment
proportion of discontinuation or temporary suspension of treatment (for any reason)
Incidence of cardiac lesions
proportion of patients with increased levels of troponin I
Incidence of cardiac disfunctions
proportion and magnitude of QTcF interval increases higher than 500ms
Change in respiratory capacity
Changes measured on day 120 will be compared to baseline, through spirometry.
Full Information
NCT ID
NCT04342650
First Posted
April 4, 2020
Last Updated
August 2, 2021
Sponsor
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
1. Study Identification
Unique Protocol Identification Number
NCT04342650
Brief Title
Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection
Acronym
CloroCOVID19II
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2020 (Actual)
Primary Completion Date
May 14, 2020 (Actual)
Study Completion Date
June 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tables of equal characteristics and duration of treatment.
Intervention Type
Drug
Intervention Name(s)
Chloroquine Diphosphate
Other Intervention Name(s)
chloroquine
Intervention Description
150mg tablets Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
150mg placebo tablets
Primary Outcome Measure Information:
Title
Proportion of patients with onset of severe acute respiratory syndrome (SARS)
Description
Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
Time Frame
7 days after randomization
Secondary Outcome Measure Information:
Title
Mortality rate
Description
Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization
Time Frame
after randomization, up to 28 days
Title
Number of participants in need of intensive care support
Description
Proportion of participants in need and duration of intensive care support after randomization
Time Frame
during and after intervention, up to 28 days
Title
Viral concentration
Description
Viral load change in blood and oropharyngeal swab samples
Time Frame
After randomization, up to 7 days
Title
Cumulative incidence of serious adverse events
Description
Incidence of serious adverse events during and after treatment
Time Frame
During and after intervention, up to 28 days
Title
Cumulative incidence of grade 3 and 4 adverse events
Description
Incidence of grade 3 and 4 adverse events during and after treatment
Time Frame
During and after intervention, up to 28 days
Title
Proportion of patients with discontinued treatment
Description
proportion of discontinuation or temporary suspension of treatment (for any reason)
Time Frame
after randomization, up to 28 days
Title
Incidence of cardiac lesions
Description
proportion of patients with increased levels of troponin I
Time Frame
after randomization, up to 120 days
Title
Incidence of cardiac disfunctions
Description
proportion and magnitude of QTcF interval increases higher than 500ms
Time Frame
after randomization, up to 120 days
Title
Change in respiratory capacity
Description
Changes measured on day 120 will be compared to baseline, through spirometry.
Time Frame
Day 120 after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
Adult aged 18 or over, at the time of inclusion
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.
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.
Facility Information:
Facility Name
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
City
Manaus
State/Province
Amazonas
ZIP/Postal Code
69093-415
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all patient data will be shared after study publication
IPD Sharing Time Frame
after study publication
IPD Sharing Access Criteria
Upon formal request to researchers.
Learn more about this trial
Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection
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