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NE3107 in Adults With Neurological Symptoms of Long COVID

NCT06847191 · BioVie Inc.
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Official title
A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults With Long COVID
About this study
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
Eligibility criteria
Key Inclusion Criteria: * 18 years to 69 years of age * Long COVID with neurological symptoms as defined below: 1. Current symptoms of at least fatigue and neurocognitive impairment that began or worsened after an index SARS-CoV-2 infection that occurred at least 3 months prior to screening. Index SARS-CoV-2 infection is defined as either: 1) an episode of COVID-19 with a positive nucleic acid or antigen test during acute illness, as documented in the medical record, or 2) a documented clinical diagnosis of COVID-19, which can be based on a patient-reported positive test for COVID-19. Note that a documented diagnosis of Long COVID is not required for inclusion. 2. Symptoms cannot be explained by any concomitant condition or diagnosis, in the opinion of the investigator. 3. 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 Key Exclusion Criteria: * 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
Study design
Enrollment target: 208 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-04-29
Estimated completion: 2026-08
Last updated: 2026-02-19
Interventions
Drug: NE3107Drug: Placebo
Primary outcomes
  • Change from Baseline in performance on the Cogstate Cognition battery (12 Weeks)
Sponsor
BioVie Inc. · industry
Contacts & investigators
ContactPenelope Markham, PhD · contact · pmarkham@bioviepharma.com
All locations (20)
Stanford UniversityRecruiting
Palo Alto, California, United States
UCSFRecruiting
San Francisco, California, United States
University of ColoradoRecruiting
Aurora, Colorado, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Clinical Trial SiteRecruiting
Jacksonville, Florida, United States
Centricity ResearchRecruiting
Columbus, Georgia, United States
Illinois Research Network University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
University of IowaRecruiting
Iowa City, Iowa, United States
Norton Infectious Disease InstituteRecruiting
Louisville, Kentucky, United States
Jadestone Clinical ResearchRecruiting
Silver Spring, Maryland, United States
Clinical Trial SiteRecruiting
Farmington Hills, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Zenos Clinical ResearchRecruiting
Dallas, Texas, United States
University of Texas health Science Center at San AntonioRecruiting
San Antonio, Texas, United States
Chronicle Bio Inc.Recruiting
Park City, Utah, United States
Swedish Center for Research and InnovationRecruiting
Seattle, Washington, United States
West Virginia UniversityRecruiting
Morgantown, West Virginia, United States
NE3107 in Adults With Neurological Symptoms of Long COVID · TrialPath