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ClinicalTrials.gov. 2021 Dec.
<h2>Condition:</h2>COVID-19;Organ Transplant<br><br><h2>Intervention:</h2>Drug: Casirivimab and Imdevimab Antibody Cocktail<br><br><h2>Primary outcome:</h2>Monitoring for SARS-CoV-2 infection<br><br><h2>Criteria:</h2><br> Inclusion Criteria: <br><br> 1. Subject provides written informed consent prior to initiation of any study procedures. <br><br> 2. Understands and agrees to comply with planned study procedures. <br><br> 3. Adult =18 years of age at time of enrollment, pediatric ages will be excluded. <br><br> 4. Subject consents to receiving a COVID-19 positive organ (kidney, liver, or heart) <br><br> a. Deceased immunocompetent donor with positive SARS-CoV-2 RT-PCR testing from the <br> respiratory tract (upper or lower): i. Within 21 days since the date of COVID-19 <br> diagnosis OR ii. Within 90 days since the date of COVID-19 diagnosis <br><br> 5. Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no <br> signs and symptoms consistent with COVID-19 <br><br> 6. All candidates must be fully vaccinated 2 weeks prior to enrollment a. When applicable <br> candidates can receive a booster vaccine as defined by the FDA/CDC <br><br> Exclusion Criteria: <br><br> 1. Any exposure to investigational medications targeting COVID-19 <br><br> 2. Previous use of casirivimab with imdevimab antibody cocktail (REGEN-COV) <br><br> 3. Previous treatment of COVID-19 with a monoclonal antibody <br><br> 4. Active COVID-19 infection <br><br> 5. Allergy to casirivimab with imdevimab <br><br> 6. Pregnant patients <br><br> 7. Prior transplant <br><br> 8. Hepatitis C virus/NCT positive deceased donors <br><br><br>
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ClinicalTrials.gov. 2021 Oct.
The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients.
Seroprevalence is a secondary objective in order to identify seronegative patients with a history of COVID-19 (ie who lost antibodies) and seropositive patients with no history of COVID-19.
The hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of COVID-19, liver transplanted patients have a lower chance of being protected after vaccination.
Seroconversion rate in previously seronegative and with no history of COVID-19 liver transplanted patients is the main evaluation criteria.
The factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population.
The rate of seroconversion after the 1st dose will also be evaluated. Safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion.
A control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis.
Persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.
https://clinicaltrials.gov/show/NCT05079165
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ClinicalTrials.gov. 2021 Sep.
Fifty living donor liver transplantation recipients during maintenance immunosuppression phase will be vaccinated against COVID-19 followed by assessment of immune response to the vaccine and further investigation of correlation of immune response to genetic polymorphisms of HLA DRB1(rs2647087) gene and IL-18 (rs187238 and rs917997) gene.
https://clinicaltrials.gov/ct2/show/NCT05051605
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ICTRP. 2021.
Immunogenicity and safety of SARS-CoV-2 vaccine in liver transplant recipients. We will investigate immune response after COVID-19 vaccination including antibody response and T-cell mediated immune response.
www.thaiclinicaltrials.org/show/TCTR20210526004
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ClinicalTrials.gov. 2021.
The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.
https://clinicaltrials.gov/show/NCT05047640
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ClinicalTrials.gov. 2021.
This study is a randomized, open-label multi-site trial designed to induce an enhanced antibody response to severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in kidney and liver transplant recipients who have negative or indeterminate (<0.8 U/mL) anti-spike antibody (as measured by the Roche Elecsys® anti-SARS-CoV-2 S assay) after at least two mRNA COVID-19 vaccines.
This study will enroll individuals who have: - Completed, at a minimum, a full 2-dose course of either the Moderna messenger RNA (mRNA) based coronavirus infectious disease 19 (COVID-19) vaccine or the Pfizer-BioNTech mRNA based COVID-19 vaccine, and - A negative or indeterminate (<0.8 U/mL) antibody response measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.
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ClinicalTrials.gov. 2018.
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ClinicalTrials.gov. 2018.
No abstract available
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ClinicalTrials.gov. 2018.
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ClinicalTrials.gov. 2018.
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