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NCT02081326 · ClinicalTrials.gov registry record · Phase 2
Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes
A Phase 2 study of COVID-19 and Autoimmune Diabetes, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT02081326: Active Phase 2 study of COVID-19 and Autoimmune Diabetes, sponsored by Massachusetts General Hospital.
NCT02081326 is a Phase 2 study of COVID-19 and Autoimmune Diabetes that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 150 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02081326, a Phase 2 study of COVID-19 and Autoimmune Diabetes, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained. Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years, or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas. An additional adaptive trial for COVID-19 is also being conducted on these randomized double blinded type 1 diabetic subjects receiving BCG or placebo injections. An expanded study arm has been approved for repeat dosing of BCG in adult Type I diabetes.
Primary Outcome
A change in the hemoglobin A1c (HbA1c) measurement compared to self
Conditions Studied
Interventions
- BIOLOGICAL Bacillus Calmette-Guérin
- BIOLOGICAL Saline injection
Study Locations (1)
Massachusetts
- Immunobiology Labs CNY 149 - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2015-06 |
| Est. Completion | 2031-07 |
| Phase | Phase 2 |
What the registry record for NCT02081326 still lists
NCT02081326 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Bacillus Calmette-Guérin is the first listed.
NCT02081326 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02081326 about?
NCT02081326 is a clinical study titled "Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes". The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white bl...
What is the current status of trial NCT02081326?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2015-06. Estimated completion is 2031-07.
What conditions does trial NCT02081326 study?
This clinical trial studies the following conditions: COVID-19, Autoimmune Diabetes, Diabetes Mellitus, Type I, Diabetes Mellitus, Type One.
What interventions are being tested in trial NCT02081326?
The interventions under investigation include: Bacillus Calmette-Guérin (BIOLOGICAL), Saline injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT02081326?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02081326 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02081326's enrollment target sits among peer trials
150 173rd of 298 higher than 123 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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