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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
EVALUATION OF COVID-19 VACCINATION EFFICACY AND CONTIXAGEVIMAB-CILGAVIMAB PROPHYLAXIS IN LIVER AND KIDNEY TRANSPLANT PATIENTS: PRELIMINARY STUDY

Conditions
-----------------
COVID-19 Pandemic, Transplant-Related Disorder

Intervention / Treatment
-----------------
* Drug: tixagevimab-cilgavimab(AZD7442, AstraZeneca)


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney and Liver Transplant<br>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. | Drug: tixagevimab-cilgavimab(AZD7442, AstraZeneca)<br>* In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 vaccination response rate | The objective of our study is the evaluation of the antibody response after complete vaccination. The anti-COVID-19 title was obtained by ECLIA Test(Elyx, Roche). | time 0 | 
| Clinical efficacy of LAAB prophylaxis | After COVID-19 title evaluation, 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. | three months from LAAB prophilaxys | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological title at six months | At six months, all the patients who underwent to to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca), the anti-COVID-19 title was obtained by ECLIA Test(Elyx, Roche). | Six months from LAAB prophylaxis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transplant, Vaccination, COVID-19 pandemic