Clinical Trial, COVID-19, SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia
Conditions
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).
Interventions
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).
DRUGPlacebo oral tablet
150mg placebo tablets
Sponsors
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mortality rate | after randomization, up to 28 days | Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization |
| 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. |
| Proportion of patients with discontinued treatment | after randomization, up to 28 days | proportion of discontinuation or temporary suspension of treatment (for any reason) |
Countries
Brazil
Outcome results
None listed