Clinical trial NCT05629923: EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS
Official title: EVALUATION OF COVID-19 VACCINATION EFFICACY AND CONTIXAGEVIMAB-CILGAVIMAB PROPHYLAXIS IN LIVER AND KIDNEY TRANSPLANT PATIENTS: PRELIMINARY STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Transplant-Related Disorder
Keywords: transplant
Vaccination
COVID-19 pandemic
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent KT and LT transplant currently in follow up in Tor Vergata University hospital

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.

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)

Primary outcomes:
measure: COVID-19 vaccination response rate
timeFrame: time 0
measure: Clinical efficacy of LAAB prophylaxis
timeFrame: three months from LAAB prophilaxys
Secondary outcomes:
measure: Serological title at six months
timeFrame: Six months from LAAB prophylaxis
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università degli Studi di Roma Tor Vergata
Study officials:
References:
citation: Hardgrave H, Wells A, Nigh J, Klutts G, Krinock D, Osborn T, Bhusal S, Rude MK, Burdine L, Giorgakis E. COVID-19 Mortality in Vaccinated vs. Unvaccinated Liver & Kidney Transplant Recipients: A Single-Center United States Propensity Score Matching Study on Historical Data. Vaccines (Basel). 2022 Nov 13;10(11):1921. doi: 10.3390/vaccines10111921.
citation: Angelico R, Blasi F, Manzia TM, Toti L, Tisone G, Cacciola R. The Management of Immunosuppression in Kidney Transplant Recipients with COVID-19 Disease: An Update and Systematic Review of the Literature. Medicina (Kaunas). 2021 Apr 30;57(5):435. doi: 10.3390/medicina57050435.
citation: Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022 Jun 9;386(23):2188-2200. doi: 10.1056/NEJMoa2116620. Epub 2022 Apr 20.