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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-08

Study Completion Date

2020-06-08

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

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.

Group Type ACTIVE_COMPARATOR

Chloroquine Diphosphate

Intervention Type DRUG

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

Placebo tables of equal characteristics and duration of treatment.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

150mg placebo tablets

Interventions

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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).

Intervention Type DRUG

Placebo oral tablet

150mg placebo tablets

Intervention Type DRUG

Other Intervention Names

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chloroquine

Eligibility Criteria

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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