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NCT05077254 · ClinicalTrials.gov registry record · Phase 2
COVID Protection After Transplant-Immunosuppression Reduction
A Phase 2 study of Kidney Transplant Recipients and Liver Transplant Recipients, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 15
- Study locations
NCT05077254 is a Phase 2 study of Kidney Transplant Recipients and Liver Transplant Recipients that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 66-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target (27% lower). The trial reports 15 study locations across 10 states.
The verdict
NCT05077254, a Phase 2 study of Kidney Transplant Recipients and Liver Transplant Recipients, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL 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.
Conditions Studied
Interventions
- BIOLOGICAL Pfizer-BioNTech COVID-19 Vaccine 2023-2024
- BIOLOGICAL Moderna COVID-19 Vaccine 2023-2024
- DRUG SOC IS Regimen
- DRUG SOC IS Reduction
Study Locations (15)
New York
- NYU Langone Transplant Institute - New York
- Mt. Sinai Hospital - New York
- Weill Cornell Medicine - New York
California
- University of California, San Diego - San Diego
- University of California San Francisco Health - San Francisco
Illinois
- University of Illinois Health - Chicago
- Northwestern University - Evanston
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pittsburgh - Pittsburgh
Georgia
- Emory Healthcare - Atlanta
Iowa
- University of Iowa Hospitals - Iowa City
Louisiana
- Ochsner Health - New Orleans
Maryland
- Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-12-06 |
| Est. Completion | 2025-02-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05077254
The ClinicalTrials.gov registry entry for NCT05077254 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 66-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target (27% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Kidney Transplant Recipients appearing as the primary indexed condition, and to 4 interventions - of which Pfizer-BioNTech COVID-19 Vaccine 2023-2024 is the first listed.
NCT05077254 reports 15 study locations spanning 10 distinct geographic areas - top geographies include New York, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05077254 about?
NCT05077254 is a clinical study titled "COVID Protection After Transplant-Immunosuppression Reduction". This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL 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 immunosuppressi...
What is the current status of trial NCT05077254?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-12-06. Estimated completion is 2025-02-21.
What conditions does trial NCT05077254 study?
This clinical trial studies the following conditions: Kidney Transplant Recipients, Liver Transplant Recipients.
What interventions are being tested in trial NCT05077254?
The interventions under investigation include: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 (BIOLOGICAL), Moderna COVID-19 Vaccine 2023-2024 (BIOLOGICAL), SOC IS Regimen (DRUG), SOC IS Reduction (DRUG).
Who is sponsoring clinical trial NCT05077254?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05077254 being conducted?
This trial has 15 study locations across California, Georgia, Illinois, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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