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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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COVID-19, SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Clinical Trial

Intervention / Treatment
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* Drug: Chloroquine Diphosphate
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>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<br>* 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).<br>* Other names: chloroquine;|
| Placebo Comparator: Placebo<br>Placebo tables of equal characteristics and duration of treatment. | Drug: Placebo oral tablet<br>* 150mg placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization | after randomization, up to 28 days | 
| Number of participants in need of intensive care support | Proportion of participants in need and duration of intensive care support after randomization | during and after intervention, up to 28 days | 
| Viral concentration | Viral load change in blood and oropharyngeal swab samples | After randomization, up to 7 days | 
| Cumulative incidence of serious adverse events | Incidence of serious adverse events during and after treatment | During and after intervention, up to 28 days | 
| Cumulative incidence of grade 3 and 4 adverse events | Incidence of grade 3 and 4 adverse events during and after treatment | During and after intervention, up to 28 days | 
| Proportion of patients with discontinued treatment | proportion of discontinuation or temporary suspension of treatment (for any reason) | after randomization, up to 28 days | 
| Incidence of cardiac lesions | proportion of patients with increased levels of troponin I | after randomization, up to 120 days | 
| Incidence of cardiac disfunctions | proportion and magnitude of QTcF interval increases higher than 500ms | after randomization, up to 120 days | 
| Change in respiratory capacity | Changes measured on day 120 will be compared to baseline, through spirometry. | Day 120 after randomization |