CloroCOVID19II: Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection
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 |
|---|---|---|
|
Phase 2 |
Study Design
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 clinicaltrials.gov refers to chloroquine base (in mg).
Other Names:
|
| Placebo Comparator: Placebo Placebo tables of equal characteristics and duration of treatment. |
Drug: Placebo oral tablet
150mg placebo tablets
|
Outcome Measures
Primary Outcome Measures
- 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
- Mortality rate [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 [during and after intervention, up to 28 days]
Proportion of participants in need and duration of intensive care support after randomization
- Viral concentration [After randomization, up to 7 days]
Viral load change in blood and oropharyngeal swab samples
- Cumulative incidence of serious adverse events [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 [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 [after randomization, up to 28 days]
proportion of discontinuation or temporary suspension of treatment (for any reason)
- Incidence of cardiac lesions [after randomization, up to 120 days]
proportion of patients with increased levels of troponin I
- Incidence of cardiac disfunctions [after randomization, up to 120 days]
proportion and magnitude of QTcF interval increases higher than 500ms
- Change in respiratory capacity [Day 120 after randomization]
Changes measured on day 120 will be compared to baseline, through spirometry.
Eligibility Criteria
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:
- Patients with chronic use of drugs known to prolong QTc interval.
Contacts and Locations
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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAAE: 30504220.5.0000.0005