Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Chloroquine + Low Dose Losartan Compared to Chloroquine Monotherapy in Subjects With SARS-CoV-2 Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall mortality
研究概览
简要总结
Study design Phase 2, double blinded, single-center, 1:1 randomized clinical trial of Chloroquine vs Chloroquine/losartan for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects
详细描述
Study design Phase 2, blinded, single-center, 1: 1 randomized clinical trial for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects. Two of the co-investigators and the data analyst will remain blind to group allocation until after statistical analysis.
The groups will consist of subjects receiving in one arm PO Chloroquine 450mg every 12 hours and in the other arm, in addition to chloroquine, PO Losartan 25mg every 24 hours. Study drugs will be administered for a total of 10 days enterally.
Baseline demographics and clinical characteristics will be registered and periodically during the study.
nasopharyngeal swabs will be taken every 48hrs during hospitalization to determine the presences and viral load of SARS-CoV-2, and daily EKG for QT interval monitoring.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
investigator will not be aware of the treatments or outcomes until the end of the study
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
- •Men or women ≥18 years.
- •Oral tolerance or access for enteral administration of medication.
- •PCR or IgM for SARS-CoV-2 positive.
- •Negative pregnancy test in case of a woman of reproductive age.
- •Signature of a document proving informed consent.
- •Hospital admission for SARS-CoV-2 pneumonia.
排除标准
- •New alteration of the state of alert that does not revert after interventions 60 minutes after hospital admission.
- •Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- •History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
- •Known patient with hearing loss.
- •Received chloroquine or hydroxychloroquine in the last 3 months.
- •Patients with cirrhosis or elevation of aspartate transaminase (AST) or alanine transaminase (ALT) greater than three times the upper normal limit.
- •Patients with calculated glomerular filtration rate by Modification of Diet in Renal Disease study equation (MDRD) < 30ml/min 1.73 m
- •Patients known to be deficient in 6-phosphate dehydrogenase
- •Patients known to have retinopathy or macular disease.
- •History of acute myocardial infarction in the last 6 months, unstable angina, ventricular tachycardia, ventricular fibrillation or class III-IV heart failure according to New York Heart Association.
- •Electrocardiogram QTc interval ≥ 480 ms.
- •Patients with hypomagnesemia or uncorrected hypokalemia.
- •Patients with a history of psychiatric illness.
- •Patients who are pregnant or nursing.
- •Patients taking quinolones, dextropropoxyphene, amiodarone, flecainide, cisapride, domperidone, atazanavir or lopinavir.
- •Patients with acute pancreatitis.
- •Patients who the investigators deem unsuitable for participation in the clinical trial.
研究组 & 干预措施
Chloroquine
Patients will receive chloroquine phosphate 450 mg every 12 hours orally
干预措施: Chloroquine Phosphate Tablets (Drug)
Chloroquine plus losartan
Patients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs
干预措施: Chloroquine Phosphate Tablets (Drug)
结局指标
主要结局
Overall mortality
时间窗: 28 days
Determine all-cause mortality up to 28 days after randomization of Chloroquine Phosphate Compared to Chloroquine Phosphate plus Losartan in Non-Critically Ill Patients with SARS-CoV-2 Pneumonia.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(28 days)
- Clinical outcome assessment(28 days)
- Time to negative SARS-CoV-2 test(28 days)
研究者
Dr. Adrian Camacho-Ortiz
Head of the Infectious Disease Department
Hospital Universitario Dr. Jose E. Gonzalez