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NCT03554265 · ClinicalTrials.gov registry record · Phase 3
Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
A Phase 3 study of COVID-19 and Traumatic Brain Injury, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT03554265: Completed Phase 3 study of COVID-19 and Traumatic Brain Injury, sponsored by The University of Texas Medical Branch, Galveston.
NCT03554265 is a Phase 3 study of COVID-19 and Traumatic Brain Injury that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 72 participants, below the 38,465-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
NCT03554265, a Phase 3 study of COVID-19 and Traumatic Brain Injury, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period.
Primary Outcome
Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.
Conditions Studied
Interventions
- DRUG Somatropin
Study Locations (1)
Texas
- University of Texas Medical Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-08-06 |
| Est. Completion | 2023-10-04 |
| Phase | Phase 3 |
What the finished NCT03554265 record still lists
NCT03554265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 38,465-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 1 intervention - of which Somatropin is the first listed.
NCT03554265 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03554265 about?
NCT03554265 is a clinical study titled "Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy". Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testi...
What is the current status of trial NCT03554265?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2018-08-06. Estimated completion is 2023-10-04.
What conditions does trial NCT03554265 study?
This clinical trial studies the following conditions: COVID-19, Traumatic Brain Injury, Fatigue, Cognitive Impairment.
What interventions are being tested in trial NCT03554265?
The interventions under investigation include: Somatropin (DRUG).
Who is sponsoring clinical trial NCT03554265?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03554265 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03554265's enrollment target sits among peer trials
72 226th of 298 higher than 72 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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