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NCT05089565 · ClinicalTrials.gov registry record
Immune Response to SARS-CoV-2/COVID-19 Vaccination in Sarcoidosis
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 101
- Enrollment target
NCT05089565: Completed study, sponsored by Northwestern University.
NCT05089565 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 101 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05089565 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 101 participants
- Enrollment target
Study Summary
People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines are highly efficacious in preventing COVID-19 in the general population, whether vaccination provides similar protection in people with sarcoidosis is unknown. The investigators hypothesize that people with sarcoidosis develop less robust antibody and cell-mediated immune responses to SARS-CoV-2 vaccination than healthy individuals, both as a consequence of the disease itself and due to treatment with immunosuppressive medications. This hypothesis will be examined by determining levels of anti-SARS-CoV-2 spike protein immunoglobulin G (IgG) antibody (Specific Aim 1) and measuring SARS-CoV-2-specific activation of peripheral blood T cells (Specific Aim 2) following SARS-CoV-2 vaccination in individuals with sarcoidosis treated and not treated with immunosuppressive medications, in comparison to age- and sex-matched healthy controls. For Specific Aim 1, a second-generation anti-SARS-CoV-2 spike IgG assay calibrated against an independent virus neutralization assay will be utilized. The results of this investigation will address a critical gap in the understanding of vaccine responses in people with sarcoidosis. In addition, the study will contribute knowledge needed to inform clinicians' recommendations to sarcoidosis patients regarding risk of infection after SARS-CoV-2 vaccination, and will help lay the basis for future trials to evaluate the possible benefit of vaccine boosters in individuals with poor immune responses to initial vaccination.
Primary Outcome
Anti-spike IgG level
Interventions
- DIAGNOSTIC_TEST Assay of (1) the level of anti-spike IgG antibody, and (2) interferon-gamma release in response to SARS-CoV-2 antigen stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2022-12-31 |
What the finished NCT05089565 record still lists
NCT05089565 is an observational study that tracks outcomes without assigning an intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Assay of (1) the level of anti-spike IgG antibody, and (2) interferon-gamma release in response to SARS-CoV-2 antigen stimulation is the first listed.
NCT05089565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05089565 about?
NCT05089565 is a clinical study titled "Immune Response to SARS-CoV-2/COVID-19 Vaccination in Sarcoidosis". People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines are highly efficacious i...
What is the current status of trial NCT05089565?
This trial is currently completed. The enrollment target is 101 participants. The study started on 2021-12-01. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT05089565?
The interventions under investigation include: Assay of (1) the level of anti-spike IgG antibody, and (2) interferon-gamma release in response to SARS-CoV-2 antigen stimulation (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05089565?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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