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

Phase 2

Completed

• Conditions: COVID-19; SARS-CoV Infection; Severe Acute Respiratory Syndrome (SARS) Pneumonia; Clinical Trial
• Interventions: Drug: Chloroquine Diphosphate; Drug: Placebo oral tablet

• Registration Number: NCT04342650
• Lead Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-04
• Study Start: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Primary Completion: 2020-05-14
• Study Completion: 2020-06-08
• Status Verified: 2020-07
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Chloroquine Diphosphate	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	Placebo oral tablet	Placebo tables of equal characteristics and duration of treatment.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cumulative incidence of serious adverse events	During and after intervention, up to 28 days	Incidence of serious 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
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
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.
Viral concentration	After randomization, up to 7 days	Viral load change in blood and oropharyngeal swab samples
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

Trial Locations

Locations (1)

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz; 🇧🇷 Manaus, Amazonas, Brazil