Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection (CloroCOVID19II)

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Status and phase: Completed; Phase 2

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

Treatments: Drug: Chloroquine Diphosphate; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04342650

CAAE: 30504220.5.0000.0005

Details and patient eligibility

About

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).

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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.

Treatment:

Drug: Chloroquine Diphosphate

Placebo

Placebo Comparator group

Description:

Placebo tables of equal characteristics and duration of treatment.

Treatment:

Drug: Placebo oral tablet