NL-OMON50845已完成4 期
ong term efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. A prospective observational cohort study by the REnal patients COVID-19 VACcination (RECOVAC) consortium - The LESS CoV-2 study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. 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
- •eGFR < 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant
- •Hemodialysis, or peritoneal dialysis
- •Kidney Transplant recipient at least 6 weeks after transplantation
排除标准
- •1. History of severe adverse reaction associated with a vaccine and/or severe
- •reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- •2.Patients who participate in the RECOVAC-IR study.
研究者
相似试验
进行中（未招募）
1 期
ong term efficacy and safety of COVID-19 vaccination in patients with a kidney diseaseCOVID-19 is associated with increased morbidity and mortality in kidneytransplant recipients (KTR) and patients with chronic kidneydisease(CKD). Therefore, potential efficacious SARS-CoV-2 vaccination would beof great clinical importance in these patients.However, SARS-CoV-2vaccination studies have excluded KTR and patients with CKD so-far and it is unknown how long a possible antibody response will endure.This will be the subject of this trial.MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 23.1Level: LLTClassification code 10084508Term: COVID-19 antibody testSystem Organ Class: 100000004848MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 23.0Level: LLTClassification code 10084463Term: SARS-CoV-2 immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10061105Term: DialysEUCTR2021-001520-18-NLRECOVAC consortium24,300
招募中
4 期
Efficacy of vaccine responses against SARS-Cov-2 in patients with giant cell arteritis and polymyalgia rheumatica (GPSVAC)NL-OMON51139niversitair Medisch Centrum Groningen80
招募中
4 期
COVID-19 vaccination in patients of Inflammatory Bowel DiseaseCTRI/2022/04/041882ICMR
暂停
不适用
Analysis of the effect of SARS-CoV-2 vaccination in patients with chronic inflammatory diseasesDRKS00024214KSH Kiel/1. medizinische Klinik/Rheumatologie100
Unknown
3 期
Study of Recombinant Protein Vaccine with Adjuvant against COVID-19 in Adults 18 Years of Age and Older.COVID-19PACTR20201152310190334,520