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NCT06631287 · ClinicalTrials.gov registry record · Phase 3
Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID
A Phase 3 study of COVID-19 and Long COVID, sponsored by Wes Ely.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 550
- Enrollment target
- 16
- Study locations
NCT06631287: Recruiting Phase 3 study of COVID-19 and Long COVID, sponsored by Wes Ely.
NCT06631287 is a Phase 3 study of COVID-19 and Long COVID that is actively recruiting participants, run by Wes Ely. The registered enrollment target is 550 participants, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 16 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06631287, a Phase 3 study of COVID-19 and Long COVID, is actively recruiting participants, sponsored by Wes Ely.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
- 16
- Study locations
Study Summary
The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.
Primary Outcome
Objective neuropsychological function determined using the CNS-Vital Signs Global Cognitive Index between study arms at 6-months, adjusted for baseline. CNS-Vital Signs Global Cognitive Index subscale is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Baricitinib
Study Locations (16)
California
- University of California, Los Angeles (UCLA) - Los Angeles
- University of California San Francisco - San Francisco
Ohio
- University Hospitals Cleveland Case Western - Cleveland
- The MetroHealth System - Cleveland
Arizona
- University of Arizona - Tucson
Colorado
- University of Colorado I Anschutz Medical Campus - Aurora
Connecticut
- Yale University - New Haven
Florida
- University of Florida College of Medicine - Gainesville
Georgia
- Emory University - Atlanta
Illinois
- Illinois Research Network (ILLInet), University of Illinois Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2024-10-21 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 3 |
What NCT06631287 shows while recruiting
NCT06631287 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06631287 lists 16 locations in 14 states (California, Ohio, Arizona).
Frequently Asked Questions
What is clinical trial NCT06631287 about?
NCT06631287 is a clinical study titled "Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID". The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomark...
What is the current status of trial NCT06631287?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2024-10-21. Estimated completion is 2027-07-01.
What conditions does trial NCT06631287 study?
This clinical trial studies the following conditions: COVID-19, Long COVID, SARS CoV 2 Infection, Coronavirus Infections.
What interventions are being tested in trial NCT06631287?
The interventions under investigation include: Placebo (OTHER), Baricitinib (DRUG).
Who is sponsoring clinical trial NCT06631287?
This trial is sponsored by Wes Ely, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06631287 being conducted?
This trial has 16 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06631287's enrollment target sits among peer trials
550 105th of 298 higher than 194 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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