Evaluating NE3107 for neurological symptoms in Long COVID patients
A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults With Long COVID
This study is testing if a new medication called NE3107 can help adults with Long COVID feel better by reducing symptoms like brain fog and fatigue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | BioVie Inc. Industry-sponsored |
| Locations | 20 sites (Palo Alto, California and 19 other locations) |
| Trial ID | NCT06847191 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of NE3107 on neurological symptoms associated with Long COVID, such as brain fog and fatigue. Participants aged 18 to 64 who have experienced these symptoms for at least three months will be randomly assigned to receive either NE3107 or a placebo for 84 days. The study includes five clinic visits for assessments and follow-up phone calls to monitor progress and side effects. The goal is to determine if NE3107 can effectively alleviate these debilitating symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 64 diagnosed with Long COVID, experiencing fatigue and brain fog for at least three months.
Not a fit: Patients who have received a COVID-19 vaccination within 30 days or have a history of major mental or physical illness prior to COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from neurological symptoms of Long COVID.
How similar studies have performed: While there have been various studies on Long COVID, the specific approach of using NE3107 for neurological symptoms is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California and 19 other locations
- Stanford University — Palo Alto, California, United States (Recruiting)
- UCSF — San Francisco, California, United States (Recruiting)
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Clinical Trial Site — Jacksonville, Florida, United States (Recruiting)
- Centricity Research — Columbus, Georgia, United States (Recruiting)
- Illinois Research Network University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Norton Infectious Disease Institute — Louisville, Kentucky, United States (Recruiting)
- Jadestone Clinical Research — Silver Spring, Maryland, United States (Recruiting)
- Clinical Trial Site — Farmington Hills, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Zenos Clinical Research — Dallas, Texas, United States (Recruiting)
- University of Texas health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
- Chronicle Bio Inc. — Park City, Utah, United States (Recruiting)
- Swedish Center for Research and Innovation — Seattle, Washington, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Penelope Markham, PhD
- Email: pmarkham@bioviepharma.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.