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

NCT04420247 | Completed Phase 3 DMC

• 1 other identifier: CLOROTRIAL
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID; COVID-19; SARS-CoV 2; Coronavirus; Corona Virus Infection

Keywords

VIRAL PNEUMONIA; CORONAVIRUS; COVID-19; COVID; SARS-COV-2

Outcome Measures

Primary Outcomes (1)

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

  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.

  14 days after randomization

Secondary Outcomes (11)

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

  5, 7, 10 and 28 days after randomization

• Mortality

  28 days after randomization

• Ventilation free days

  28 days after randomization

• ICU Lenght of Stay

  28 days after randomization

• Hospital Lenght of Stay

  28 days after randomization

Other Outcomes (1)

• Arrhythmia

  28 days after randomization

Study Arms (2)

Intervention

EXPERIMENTAL

Treatment with either Chloroquine or Hydroxychloroquine according to what was available in the hospital: Chloroquine - 900mg on the first day, followed by 450mg in the next 4 days. Hydroxychloroquine - 800mg on the first day, followed by 450mg in the next 4 days. \+ Standard treatment available and recomended by the Brazilian Guidelines for COVID-19.

Drug: Chloroquine; Drug: Hydroxychloroquine

Control

ACTIVE COMPARATOR

Standard treatment available and recomended by the Brazilian Guidelines for COVID-19.

Other: standard care

Interventions

Chloroquine DRUG

5 days of treatment with Chloroquine + Standard Care

Intervention

Hydroxychloroquine DRUG

5 days of treatment with Hydroxychloroquine + Standard Care

Intervention

standard care OTHER

Standard Care according to Brazilian Guidelines for treating COVID-19

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva: lead

Study Sites (1)

Centro de Estudos e Pesquisa em Emergencias Clinicas e Terapia Intensiva

Curitiba, Paraná, 82530200, Brazil

Location

Related Publications (1)

• Rea-Neto A, Bernardelli RS, Camara BMD, Reese FB, Queiroga MVO, Oliveira MC. An open-label randomized controlled trial evaluating the efficacy of chloroquine/hydroxychloroquine in severe COVID-19 patients. Sci Rep. 2021 Apr 27;11(1):9023. doi: 10.1038/s41598-021-88509-9.

  PMID: 33907251 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Pneumonia, Viral

Interventions

Chloroquine; Hydroxychloroquine; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Reseach Center

Model Details: Two arms - Intervention and Control Intervention received unblinded treatment with Chloroquine or Hyroxycloroquine for 5 days, as well as standard treatment available and recomended by the Brazilian Guidelines for COVID-19. Control group received just the standard treatment available and recomended by the Brazilian Guidelines for COVID-19.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: April 16, 2020
• Primary Completion: August 20, 2020
• Study Completion: September 3, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)