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Completed

NCT Number: NCT04342650

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

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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Key information

Conditions

COVID-19 Clinical Trial Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV Infection Severe Acute Respiratory Syndrome Severe Acute Respiratory Syndrome (SARS) Pneumonia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz

Manaus, Amazonas, 69093-415, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
  • Adult aged 18 or over, at the time of inclusion
  • 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.
  • Patients with comorbidities only, due to the increased risk of developing SARS

Exclusion criteria

  • Patients with chronic use of drugs known to prolong QTc interval.

Treatment and study plan

Chloroquine diphosphate

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).

Other names: chloroquine

Placebo oral tablet

Drug

150mg placebo tablets

Primary outcomes

  1. Proportion of patients with onset of severe acute respiratory syndrome (SARS)

    Time frame: 7 days after randomization

    Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.

Secondary outcomes

  1. Mortality rate

    Time frame: after randomization, up to 28 days

    Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization

  2. Number of participants in need of intensive care support

    Time frame: during and after intervention, up to 28 days

    Proportion of participants in need and duration of intensive care support after randomization

  3. Viral concentration

    Time frame: After randomization, up to 7 days

    Viral load change in blood and oropharyngeal swab samples

  4. Cumulative incidence of serious adverse events

    Time frame: During and after intervention, up to 28 days

    Incidence of serious adverse events during and after treatment

  5. Cumulative incidence of grade 3 and 4 adverse events

    Time frame: During and after intervention, up to 28 days

    Incidence of grade 3 and 4 adverse events during and after treatment

  6. Proportion of patients with discontinued treatment

    Time frame: after randomization, up to 28 days

    proportion of discontinuation or temporary suspension of treatment (for any reason)

  7. Incidence of cardiac lesions

    Time frame: after randomization, up to 120 days

    proportion of patients with increased levels of troponin I

  8. Incidence of cardiac disfunctions

    Time frame: after randomization, up to 120 days

    proportion and magnitude of QTcF interval increases higher than 500ms

  9. Change in respiratory capacity

    Time frame: Day 120 after randomization

    Changes measured on day 120 will be compared to baseline, through spirometry.

Sponsors and collaborators

Lead sponsor

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Other

Registry information

Official study 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

Acronym: CloroCOVID19II

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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