The Greek study in the Effects of Colchicine in Covid-19 complications prevention - GRECCO-19

Hellenic Society of Rhythmology0 个研究点目标入组 180 人开始时间: 2020年4月1日最近更新: 2020年10月26日

试验速览

暂无简介。

•1. Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical status that involves body temperature >37.5 oC
•2. at least two out of the:
•i. sustained coughing,
•ii. sustained throat pain,
•iii. anosmia and/or ageusia,
•iv. fatigue/tiredness,
•v. PaO2<95 mmHg.
•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 54
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 126

•1. Pregnancy, breastfeeding, or unwillingness to take effective contraceptive methods in men and women of reproductive ability during the clinical trial
•2. Hypersensitivity in Colchicine or in any of the excipients of the product (lactose, gum arabic, sucrose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, methylene casein, erythrosine lacquer).
•3. Serious hepatic failure
•4. eGFR<20 ml/min/1.73m2
•5. Clinical estimation that the patient will require mechanical respiratory support in less than 24 hours.
•6. Any clinical estimation of the attending physician under which the patient shall be excluded
•7. QTc > 450 msec.
•8. Participation in a clinical trial with a research product (medication or device) or intervention.
•9. Being treated with colchicine for other indications.
•10. A person who, at the discretion of the Researcher, is unable to comply with or participate in the clinical trial may place it at unacceptable health risks.
•11. A person undergoing haemodialysis
•12. Severe gastrointestinal failure, severe gastrointestinal disorder, or stomach ulcer
•13. Hematological disorders, such as blood disease
•14. Under treatment or 14 days after use of P-glycoprotein inhibitors or CYP3A4 enzyme inhibitors

发起方

Hellenic Society of Rhythmology