The immune-response and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant - The RECOVAC IR study

RECOVAC consortium0 个研究点目标入组 850 人开始时间: 2021年2月17日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•1. All patients should be eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
•2. Age of 18 years or older
•3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
•- CKD4/5, with an eGFR <30 ml/min*1.73m2 by CKD-EPI
•- Hemodialysis, or peritoneal dialysis
•- Kidney transplant recipient at least 6 weeks after transplantation
•- Partner, sibling, or other family member of participating patient with eGFR > 45 ml/min * 1,73 m2
•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 570
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 280

•-History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) toany component of the study intervention(s).
•-Multi-organ recipients
•-Previous or active COVID-19 disease
•-Active (haematological) malignancy
•-Inherited immune deficiency
•-Infection with Human Immunodeficency Virus (HIV)
•-Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

发起方

RECOVAC consortium