Official Title
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
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).

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

Drug: Chloroquine Diphosphate
150mg tablets
Intervention
Other Name: chloroquine

Drug: Placebo oral tablet
150mg placebo tablets
Placebo

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Brazil
Contacts

Marcus Lacerda, MD
+55 92 99114 7633
marcuslacerda.br@gmail.com

Fernando Val, PhD
+55 92 99116 3107
ffaval@gmail.com

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
NCT Number
MeSH Terms
Infection
Severe Acute Respiratory Syndrome
Coronavirus Infections
Pneumonia
Syndrome
Chloroquine
Chloroquine diphosphate