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

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado152 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

152

Conditions

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

Interventions

Chloroquine DiphosphateDRUG

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).

Placebo oral tabletDRUG

150mg placebo tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz

Manaus, Amazonas, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 7 days after randomization

Secondary Outcomes

Mortality rate

Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization

Time frame: 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

Time frame: during and after intervention, up to 28 days

Viral concentration

Viral load change in blood and oropharyngeal swab samples

Time frame: After randomization, up to 7 days

Cumulative incidence of serious adverse events

Incidence of serious adverse events during and after treatment

Time frame: 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

Time frame: 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)

Time frame: after randomization, up to 28 days

Incidence of cardiac lesions

proportion of patients with increased levels of troponin I

Time frame: after randomization, up to 120 days

Incidence of cardiac disfunctions

proportion and magnitude of QTcF interval increases higher than 500ms

Time frame: after randomization, up to 120 days

Change in respiratory capacity

Changes measured on day 120 will be compared to baseline, through spirometry.

Time frame: Day 120 after randomization

Data from ClinicalTrials.gov

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