EUCTR2020-001482-37-DE进行中（未招募）1 期
Randomized controlled trial of hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of elderly COVID-19 Patients
niversity Hopsital Tuebingen0 个研究点目标入组 350 人开始时间: 2020年4月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent
- •Age = 65 years
- •Mild to moderate symptomatic respiratory tract Infection
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •Hospitalization at study inclusion
- •Weight <50 kg
- •Acute myocardial infarction
- •Use of concomitant medications that prolong the QT/QTc interval.
- •QTc >450ms
- •Bilirubin = 1,5 x UNL,
- •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)
- •History of Retinopathy or Maculopathy
- •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
- •Subject (male or female) is not willing to use highly effective methods of contraception according to the Clinical trial fertility group” recommendations (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment until day 30 from first dose (adequate: combined hormonal contraceptionassociated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormonereleasing-system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2).
- •1 Vasectomized partner is a highly effective birth control method provided that partner is the
- •sole sexual partner of the WOCBP trial participant and that the vasectomized partner has
- •received medical assessment of the surgical success2 In the context of this guidance sexual
- •abstinence is considered a highly effective method only if defined as refraining from
- •heterosexual intercourse during the entire period of risk associated with the study treatments.
- •The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject
研究者
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