NCT04342650

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	Chloroquine Diphosphate	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).
DRUG	Placebo oral tablet	150mg placebo tablets

Timeline

• Start date: 2020-04-08
• Primary completion: 2020-05-14
• Completion: 2020-06-08
• First posted: 2020-04-13
• Last updated: 2021-08-09

Locations

1 site across 1 country: Brazil