An adaptive Phase 2/3, randomized, open-label study assessing efficacy and safety of hydroxychloroquine for hospitalized patients with moderate to severe COVID-19

sanofi-aventis recherche & développement0 个研究点目标入组 350 人开始时间: 2020年4月6日最近更新: 2020年7月6日

适应症

试验速览

暂无简介。

•- Participants must be hospitalized with illness consistent with COVID-19 pneumonia by chest imaging and/or clinical examination and with moderate to severe disease
•- Laboratory-confirmed SARS-CoV-2 infection
•- Onset of COVID-19 symptoms =5 days before randomization
•- Women of childbearing potential must have a negative highly sensitive pregnancy test at screening and should agree to use an acceptable contraceptive method
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 175
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 175

•- Unlikely to survive for >48 hours from screening
•- Participants with critical disease or multi-organ failure
•- Any contraindication to HCQ or intolerance to HCQ
•- Any medical condition or concomitant therapy that may put the particpants at risk if they are treated with HCQ
•- Pregnant or breastfeeding women
•- Use of antiarrhythmic medications and medications known to prolong QT interval or cause Torsades de Pointes (TdPs)
•- Participants with history of congenital or acquired long QT, arrhythmia, family history of long QT or sudden cardiac death, or any other cardiac condition that, by the judgement of the Investigator, would put the patient at higher risk for QTc prolongation or sudden cardiac death
•- Participants with the following ECG findings at screening: QTcF >470 msec for women or >450 msec for men or heart rate <50 beats/minute
•- Participants with known glucose-6-phosphate dehydrogenase (G6PD) deficiency

发起方