NCT04351516撤回2 期
Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- ● Rate of hospitalization or death at day 7 after study inclusion
研究概览
简要总结
Patients over equal or older than 65 yearswill be treated with a hydroxychloroquine versus placebo reduced loading dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days resulting in a total duration of therapy of 7 days. Measurement of Hydroxychloroquine-levels will be performed on day 7, . A follow-up by video or telephone conference will be performed to observe drug intake and collect adverse events during treatment phase on a daily base on working days and once during the weekend (i.e. 6 out of 7 days). After treatment phase follow-up by telephone calls will be done on day 10, 30, 60 (+/- 2 days).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age ≥ 65 years
- •Mild to moderate symptomatic respiratory tract Infection defined as not requiring hospital admission: SpO2 >94%, respiratory rate <20, mental state alert, no signs of septic shock
- •Proven SARS-Cov2 infection by throat swab (PCR)
- •Onset of symptoms within the last 3 days before randomization
- •Must be able to adhere to the study visit schedule and other protocol requirements in the investigator's opinion. I.e. must be able to answer to questions concerning symptoms and side effects and must be able to consent to the informed consent.
排除标准
- •Hospitalization at study inclusion
- •Weight <50 kg
- •Acute myocardial infarction
- •Severe heart failure, characterized as NYHA class 3 or 4
- •Use of concomitant medications that prolong the QT/QTc interval.
- •QTc >450ms
- •Bilirubin ≥ 1,5 x UNL, (except for known M. Meulengracht)
- •AST/ALT ≥ 3 x ULN
- •Albumine ≤ 2.8 g/dl
- •Hemoglobin ≤ 9 g/dl
- •Leucocytes ≤ 2000/µl
- •Neutrophiles ≤ 1000/µl
- •Thrombocytes ≤ 100.000/µl
- •Troponin elevation
- •BNP > 500 pg/ml
- •Creatine kinase > 5 x ULN
- •Creatinine >1,5 mg/dl
- •Uncorrected hypopotassemia or hypomagnesemia
- •History of hypoglycemic events
- •History of or present cardial arrhythmia (except atrial fibrillation or paroxysmal supraventricular tachycardia)
- •Bradycardia < 60 beats/min
- •History of Retinopathy or Maculopathy
- •Psoriasis
- •Myasthenia gravis
- •Immunodeficiency syndromes or need for highly immunosuppressive medication
- •Pre-existing medication with hydroxychloroquine
- •Known G6PD deficiency.
- •Participation in another interventional study
- •Known hypersensibility to hydroxychloroquine and its derivates
研究组 & 干预措施
hydroxychloroquine
Experimental
干预措施: Hydroxychloroquine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
● Rate of hospitalization or death at day 7 after study inclusion
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (2)
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