EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS

University of Rome Tor Vergata

Status: Completed

Conditions: Transplant-Related Disorder; COVID-19 Pandemic

Treatments: Drug: tixagevimab-cilgavimab(AZD7442, AstraZeneca)

Study type: Observational

Funder types: Other

Identifiers

NCT05629923

COVID-19 TRANPLANT

Details and patient eligibility

About

The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are:

• the evaluation of the antibody response after complete vaccination
• the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)

All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.

Full description

Liver(LT) and kidney(KT) transplant patients are at high risk of mortality from COVID-19(16-29%, 28%; respectively). Although transplant patients undergo a full vaccination course(3 doses), they are frequently low-responders and long-acting-antibody prophylaxis (LAAB) has been proposed. However, the efficacy of these strategies has not yet been demonstrated in LT and KT.

The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are:

• the evaluation of the antibody response after complete vaccination
• the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)

All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.

Enrollment: 306 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• KT and LT transplant patients in follow up in Tor Vergata University
• Age >18 years
• At least 3 month post transplantation

Exclusion criteria

• pediatric recipients
• Active covid infection at the time of the study
• Pregnancy
• Allergy to any ingredients included in the vaccine
• Acute liver or kidney acute rejection proven by biopsy
• Acute Febrile state with either leucopenia or leucocytosis
• High dose of corticosteroid at study timing (pulse methyl prednisolone)

Trial design

306 participants in 1 patient group

Kidney and Liver Transplant

Description:

All Kidney and Liver Transplant recipients who are at follow-up in our institution will be enrolled. anti-COVID-19 title was obtained by ECLIA Test(Elyx, Roche). In the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection.

Treatment:

Drug: tixagevimab-cilgavimab(AZD7442, AstraZeneca)