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

NCT ID: NCT04420247

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2020-09-03

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.

Detailed Description

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Chloroquine

Intervention Type: DRUG

5 days of treatment with Chloroquine + Standard Care

Hydroxychloroquine

Intervention Type: DRUG

5 days of treatment with Hydroxychloroquine + Standard Care

Control

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

Group Type: ACTIVE_COMPARATOR

standard care

Intervention Type: OTHER

Standard Care according to Brazilian Guidelines for treating COVID-19

Interventions

Chloroquine

5 days of treatment with Chloroquine + Standard Care

Intervention Type: DRUG

Hydroxychloroquine

5 days of treatment with Hydroxychloroquine + Standard Care

Intervention Type: DRUG

standard care

Standard Care according to Brazilian Guidelines for treating COVID-19

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva

OTHER

Sponsor Role: lead

Responsible Party

ALVARO REA-NETO, MD

Director of the Reseach Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Estudos e Pesquisa em Emergencias Clinicas e Terapia Intensiva

Curitiba, Paraná, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33907251 (View on PubMed)

Other Identifiers

CLOROTRIAL

Identifier Type: -

Identifier Source: org_study_id