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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- World Health Organization (WHO) 9-levels ordinal scale (from 0-8)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Chloroquine (Drug)
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.
干预措施: Hydroxychloroquine (Drug)
Control
Standard treatment available and recomended by the Brazilian Guidelines for COVID-19.
干预措施: standard care (Other)
结局指标
主要结局
World Health Organization (WHO) 9-levels ordinal scale (from 0-8)
时间窗: 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.
次要结局
- Mortality(28 days after randomization)
- Ventilation free days(28 days after randomization)
- Mean of C Reactive Protein Levels(5, 7, 10, 14 and 28 days after randomization)
- Coagulopathy incidence(28 days after randomization)
- Sequential Organ Failure Assessment (SOFA) scores(5, 7, 10, 14 and 28 days after randomization)
- ICU Lenght of Stay(28 days after randomization)
- Hospital Lenght of Stay(28 days after randomization)
- Neutrophils/lymphocytes ratio(5, 7, 10, 14 and 28 days after randomization)
- Percentage of patients needing dialysis(28 days after randomization)
- World Health Organization (WHO) 9-levels ordinal scale (from 0-8)(5, 7, 10 and 28 days after randomization)
- Acute Kidney Disease incidence(28 days after randomization)
研究者
ALVARO REA-NETO, MD
Director of the Reseach Center
Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva