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

COVID-19 Clinical Trial

— CloroCOVID19II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342650
• Other study ID #: CAAE: 30504220.5.0000.0005
• Status: Completed
• Phase: Phase 2
• Start date: April 8, 2020
• Est. completion date: June 8, 2020

Study information

• Verified date: July 2020
• Source: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 8, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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).
• Placebo oral tablet
150mg placebo tablets

Locations

Country	Name	City	State
Brazil	Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz	Manaus	Amazonas

Sponsors (1)

Lead Sponsor	Collaborator
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Country where clinical trial is conducted

Brazil, 

Outcome

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