NE3107 in Adults With Neurological Symptoms of Long COVID
ADDRESS-LC
A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults With Long COVID
2 other identifiers
interventional
208
1 country
20
Brief Summary
Long COVID is a condition where debilitating symptoms can persist for months after a COVID-19 infection. This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or remembering things ("brain fog") and fatigue. Researchers will compare NE3107 to a placebo (a look-alike substance that contains no drug) to see if NE3107 works to treat neurocognitive and fatigue symptoms of long COVID. Participants will:
- Take NE3107 or a placebo twice daily for 84 days
- Visit the clinic 5 times for checkups and tests and have a follow up phone call
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2025
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
February 19, 2026
January 1, 2026
1.1 years
February 24, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in performance on the Cogstate Cognition battery
Objective computerized neurocognitive testing assessing attention, sustained attention, verbal memory, verbal learning, psychomotor function and processing speed. A composite cognitive score is calculated as the mean of standardized (z-score-transformed) performance scores across the tasks. Higher composite scores indicate better cognitive performance.
12 Weeks
Secondary Outcomes (5)
Change from Baseline in PROMIS Cognitive Function Short Form 8a (SF-8a)
12 Weeks
Change from Baseline in PROMIS Fatigue Short Form 13a (SF-13a)
12 Weeks
Change from Baseline in PROMIS Sleep Disturbance Short Form 8a (SF-8a)
12 Weeks
Change from Baseline in SF-12 Health Survey (Physical and Mental Component Scores)
12 Weeks
Change from Baseline in DePaul Symptom Questionnaire (DSQ) Post-Exertional Malaise (PEM
12 Weeks
Study Arms (2)
NE3107
EXPERIMENTALOne 20 mg capsule containing NE3107 taken by mouth twice daily (BID)
Placebo
PLACEBO COMPARATOROne 20 mg capsule containing placebo taken by mouth twice daily (BID)
Interventions
Eligibility Criteria
You may qualify if:
- years to 69 years of age
- Long COVID with neurological symptoms as defined below:
- Symptoms cannot be explained by any concomitant condition or diagnosis, in the opinion of the investigator.
- Symptom duration for at least 3 months. diagnosed with Long COVID with symptoms of fatigue and brain fog for at least 3 months
- Agree to maintain any other regular medications at current doses for the duration of the trial (except for essential need of new medication or dose change, as prescribed by a physician)
- Agree to use birth control measures
- Provide voluntary consent
- Willing to allow blood collection
- Pass all screening tests and procedures
You may not qualify if:
- Has received a COVID-19 vaccination within 14 days
- Previous admission to the intensive care unit for COVID-19
- Medical history of major mental or physical illness prior to COVID-19 infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioVie Inc.lead
Study Sites (20)
Stanford University
Palo Alto, California, 94304, United States
UCSF
San Francisco, California, 94110, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06519, United States
Clinical Trial Site
Jacksonville, Florida, 32258, United States
Centricity Research
Columbus, Georgia, 31904, United States
Illinois Research Network University of Illinois at Chicago
Chicago, Illinois, 60608, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Norton Infectious Disease Institute
Louisville, Kentucky, 40202, United States
Jadestone Clinical Research
Silver Spring, Maryland, 20904, United States
Clinical Trial Site
Farmington Hills, Michigan, 48334, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
University of Texas health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Chronicle Bio Inc.
Park City, Utah, 84119, United States
Swedish Center for Research and Innovation
Seattle, Washington, 98104, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The participant, investigator, assessors, or any member of the study staff at the CRO or sponsor will be masked to the treatment assignments.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2025
First Posted
February 26, 2025
Study Start
April 29, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
February 19, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share