EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS
Study Details
Study Description
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:
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the evaluation of the antibody response after complete vaccination
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Kidney and Liver Transplant 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)
In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca).
|
Outcome Measures
Primary Outcome Measures
- COVID-19 vaccination response rate [time 0]
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).
- Clinical efficacy of LAAB prophylaxis [three months from LAAB prophilaxys]
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.
Secondary Outcome Measures
- Serological title at six months [Six months from LAAB prophylaxis]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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KT and LT transplant patients in follow up in Tor Vergata University
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Age >18 years
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At least 3 month post transplantation
Exclusion Criteria:
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pediatric recipients
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Active covid infection at the time of the study
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Pregnancy
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Allergy to any ingredients included in the vaccine
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Acute liver or kidney acute rejection proven by biopsy
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Acute Febrile state with either leucopenia or leucocytosis
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High dose of corticosteroid at study timing (pulse methyl prednisolone)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Università degli Studi di Roma Tor Vergata | Roma | Italy | 00133 |
Sponsors and Collaborators
- University of Rome Tor Vergata
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- COVID-19 TRANPLANT