COBRA-KAI study: COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after vaccination of a kaleidoscopic group hematological patients, what’s the impact? - COBRA-KAI

Amsterdam UMC location VUmc0 个研究点目标入组 850 人开始时间: 2021年2月27日最近更新: 2021年3月8日

试验速览

暂无简介。

•- Age =18 years
•- The following patient cohorts will be included: B-cell non Hodgkin lymphoma, multiple myeloma, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative diseases (MPN), patients with hemoglobinopathies (sickle cell disease and thalassemia), patients who received cell therapy (autologous HCT, allogeneic HCT or CAR T-cell therapy) AND
•- Patients must either currently receive immuno-chemotherapy or have received such therapy in the past 6 months, or currently receive targeted agents, or have received autologous or allogeneic stem cell transplantation no longer than 6 months prior, or have received CAR-T therapy.
•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 600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

•- Unwilling or unable to give informed consent
•- Known allergy to one of the components of the vaccine
•- Patients with a life expectancy of < 12 months
•- Of note: although we will investigate serologic evidence of prior infection with SARS-CoV-2 in all participants, seropositivity is not an exclusion criterion. The main reasons for this are first that we expect seroprevalence to be well below 5%, because of the stringent isolation measures that are already in place in this patient population; second, a test-first-strategy for seroprevalence would seriously hamper the speed of vaccination rollout, whereas vaccination of seropositive patients is indicated nonetheless, according to the national vaccination guidelines

发起方

Amsterdam UMC location VUmc