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Completed

NCT Number: NCT04420247

Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

Facing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established, for efficacy in treating COVID-19 and improving an ordinal primary outcome composed by a 9-levels scale, which was recomended by the World Health Organization.

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Key information

Conditions

COVID COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Estudos e Pesquisa em Emergencias Clinicas e Terapia Intensiva

Curitiba, Paraná, 82530200, Brazil

About this study

This is a Phase 3, Pragmatic, Multicentric Randomized Controled Trial of efficacy to test the effect of either Chloroquine or Hydroxychloroquine for 5 days in the recomended dose standardized by brazilian Ministry of Health.

Patients were randomized (1:1) using stratified randomization by hospital and severity at the moment of randomization (stipulated by use of mechanical ventilation or not) into two arms: Intervention and Control. Intervention group recieved a loading dose of 900mg of Chloroquine or 800mg of Hydroxycloroquine in the first day, followed by 450mg of chloroquine of 400mg of hydroxychloroquine. Primary and secondary outcomes were evaluated on the 5th, 7th, 10th, 14th, 28th day after randomization.

Although the outcomes presented in the latest version were updated late on ClinicalTrials.org, on October 23, 2020, these outcomes were already present in the trial protocol approved by the Brazilian National Commission for Ethics in Research on April 8, 2020 (approval number: 3960331) and amending the protocol, approved by the same National Commission on May 25, 2020 (approval number: 4044848)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Males and non-pregnant females that accept and sign the informed consent.
  • Hospitalized with COVID-19 suspection that has collected the confirmatory test
  • To have at least one of thes symptoms: Fever, coughing, throat ache or runny nose.
  • To have at least one of these findings: radiological findings that indicates COVID-10 (bilatareal ground grass images); O2 saturation lower than 94% without supplementation and crackles in lung auscultation; Need of O2 supplementation; Need of Mechanical Ventilation.
  • Female patients must also agree to use efficient counterceptive methods during the evaluation period.

Exclusion criteria

  • Patients with psoriasis or other exfoliative disease, porphyria, epilepsy, myasthenia gravis, advanced liver failure or glucose-6-phosphate dehydrogenase deficiency.
  • ALT / AST> 5 times the upper limit of normal.
  • Severe chronic kidney disease in stage 4 or requiring dialysis (ie, eGFR <30).
  • Pregnancy or breastfeeding.
  • Early transfer to another hospital that is not a study site within 72 hours.
  • Severe heart disease and / or a history of cardiac arrhythmia.
  • Allergy to Chloroquine and / or Hydroxychloroquine.

Treatment and study plan

Chloroquine

Drug

5 days of treatment with Chloroquine + Standard Care

Hydroxychloroquine

Drug

5 days of treatment with Hydroxychloroquine + Standard Care

Standard care

Other

Standard Care according to Brazilian Guidelines for treating COVID-19

Primary outcomes

  1. World Health Organization (WHO) 9-levels ordinal scale (from 0-8)

    Time frame: 14 days after randomization

    Evaluation of the clinical status of patients on the 14th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes.

Secondary outcomes

  1. World Health Organization (WHO) 9-levels ordinal scale (from 0-8)

    Time frame: 5, 7, 10 and 28 days after randomization

    Evaluation of the clinical status of patients on the 5th, 7th, 10th and 28th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes.

  2. Mortality

    Time frame: 28 days after randomization

    All-cause mortality at 28 days after randomization

  3. Ventilation free days

    Time frame: 28 days after randomization

    Number of days without need of Mechanical Ventilation at 28 days after randomization

  4. ICU Lenght of Stay

    Time frame: 28 days after randomization

    ICU Lenght of Stay on survivors at 28 days after randomization

  5. Hospital Lenght of Stay

    Time frame: 28 days after randomization

    Hospital Lenght of Stay on survivors at 28 days after randomization

  6. Acute Kidney Disease incidence

    Time frame: 28 days after randomization

    Acute Kidney Disease incidence measured by Kidney Disease Improving Global Outcomes (KDIGO) stage 3 sometime until the 28th day after randomization.

  7. Percentage of patients needing dialysis

    Time frame: 28 days after randomization

    Percentage of patients needing dialysis sometime until the 28th day.

  8. Coagulopathy incidence

    Time frame: 28 days after randomization

    Presence of coagulopathy sometime until the 28th day (platelets < 150000 and/or INR >1.5 and/or KPTT > 35 seconds).

  9. Mean of C Reactive Protein Levels

    Time frame: 5, 7, 10, 14 and 28 days after randomization

    Mean of C Reactive Protein Levels on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization

  10. Sequential Organ Failure Assessment (SOFA) scores

    Time frame: 5, 7, 10, 14 and 28 days after randomization

    Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization.

  11. Neutrophils/lymphocytes ratio

    Time frame: 5, 7, 10, 14 and 28 days after randomization

    Neutrophils/lymphocytes ratio on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization.

Other outcomes

  1. Arrhythmia

    Time frame: 28 days after randomization

    Safety outcome: Any kind of arrhythmia identified by the attending physician at the time of the intercurrence, confirmed by an electrocardiogram (ECG), sometime until the 28th day

Sponsors and collaborators

Lead sponsor

Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva

Other

Registry information

Official study title

Multicentric Pragmatic Randomized Controled Trial to Evaluate the Efficacy Chloroquine or Hydroxychloroquine for Five Days in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
May 12, 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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