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

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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Amazonas
    • Manaus, Amazonas, Brazil, 69093-415
      • Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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).; Other Names: chloroquine
PLACEBO_COMPARATOR: Placebo; Placebo tables of equal characteristics and duration of treatment.	Drug: Placebo oral tablet; 150mg placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with onset of severe acute respiratory syndrome (SARS)	Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.	7 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization	after randomization, up to 28 days
Number of participants in need of intensive care support	Proportion of participants in need and duration of intensive care support after randomization	during and after intervention, up to 28 days
Viral concentration	Viral load change in blood and oropharyngeal swab samples	After randomization, up to 7 days
Cumulative incidence of serious adverse events	Incidence of serious adverse events during and after treatment	During and after intervention, up to 28 days
Cumulative incidence of grade 3 and 4 adverse events	Incidence of grade 3 and 4 adverse events during and after treatment	During and after intervention, up to 28 days
Proportion of patients with discontinued treatment	proportion of discontinuation or temporary suspension of treatment (for any reason)	after randomization, up to 28 days
Incidence of cardiac lesions	proportion of patients with increased levels of troponin I	after randomization, up to 120 days
Incidence of cardiac disfunctions	proportion and magnitude of QTcF interval increases higher than 500ms	after randomization, up to 120 days
Change in respiratory capacity	Changes measured on day 120 will be compared to baseline, through spirometry.	Day 120 after randomization

Collaborators and Investigators

• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2020
• Primary Completion (ACTUAL): May 14, 2020
• Study Completion (ACTUAL): June 8, 2020

Study Registration Dates

• First Submitted: April 4, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (ACTUAL): April 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Severe Acute Respiratory Syndrome; COVID-19; Syndrome; Infections; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Amebicides; Filaricides; Antinematodal Agents; Anthelmintics; Chloroquine; Chloroquine diphosphate
• Other Study ID Numbers: CAAE: 30504220.5.0000.0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all patient data will be shared after study publication
• IPD Sharing Time Frame: after study publication
• IPD Sharing Access Criteria: Upon formal request to researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No