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NCT04969263 · ClinicalTrials.gov registry record · Phase 2

COVID-19 Protection After Transplant Pilot Study

A Phase 2 study of Kidney Transplant Recipients, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
81
Enrollment target
1
Study location

NCT04969263: Completed Phase 2 study of Kidney Transplant Recipients, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT04969263 is a Phase 2 study of Kidney Transplant Recipients that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 81 participants, above the 58-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target (40% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04969263, a Phase 2 study of Kidney Transplant Recipients, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
81 participants
Enrollment target
1
Study location

Study Summary

Antibodies are an important part of the body's defense against infection. Individuals who have no antibodies or very low antibody levels are considered less well protected from Coronavirus Disease 2019 (COVID-19) than those who have higher antibody levels. What level of antibodies is necessary for protection is currently unknown. Inadequate antibody response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination has been described among kidney transplant recipients. The aim of this study is to elicit an antibody response to vaccination against SARS-CoV-2 in kidney transplant recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) vaccine.

Primary Outcome

The proportion of participants who achieve an antibody response \>50 U/mL after the third dose of vaccine using the Roche Elecsys® anti-RBD assay is considered to show positive response to the intervention, negative response otherwise.

Conditions Studied

Kidney Transplant Recipients

Interventions

  • BIOLOGICAL BNT162b2 vaccine (Pfizer/BioNTech)
  • BIOLOGICAL mRNA-1273 vaccine (Moderna)

Study Locations (1)

Maryland

  • Johns Hopkins Hospital - Baltimore

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2021-08-10
Est. Completion 2023-03-10
Phase Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT04969263 record still lists

NCT04969263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 58-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target (40% higher).

The record links to 1 condition, with Kidney Transplant Recipients appearing as the primary indexed condition, and to 2 interventions - of which BNT162b2 vaccine (Pfizer/BioNTech) is the first listed.

NCT04969263 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT04969263 about?

NCT04969263 is a clinical study titled "COVID-19 Protection After Transplant Pilot Study". Antibodies are an important part of the body's defense against infection. Individuals who have no antibodies or very low antibody levels are considered less well protected from Coronavirus Disease 2019 (COVID-19) than those who have higher antibody levels. What level of antibodies is necessary for p...

What is the current status of trial NCT04969263?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2021-08-10. Estimated completion is 2023-03-10.

What conditions does trial NCT04969263 study?

This clinical trial studies the following conditions: Kidney Transplant Recipients.

What interventions are being tested in trial NCT04969263?

The interventions under investigation include: BNT162b2 vaccine (Pfizer/BioNTech) (BIOLOGICAL), mRNA-1273 vaccine (Moderna) (BIOLOGICAL).

Who is sponsoring clinical trial NCT04969263?

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 NCT04969263 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT04969263, the US trial registry maintained by the National Library of Medicine. NCT04969263 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.