NE3107 in Adults With Neurological Symptoms of Long COVID

NCT06847191 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: NE3107-LC-201CDMRP-PR230631
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 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

Conditions

Long COVID

Keywords

COVID-19; Neurocognition; Fatigue; Post-exertional malaise; Sleep; SARS-CoV-2; Brain fog

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. \*This study is designed as a signal-seeking proof-of-concept Phase 2 study. The primary outcome is intended for estimation and hypothesis generation rather than formal hypothesis testing. No single endpoint is designated as definitive for study success

  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

EXPERIMENTAL

One 20 mg capsule containing NE3107 taken by mouth twice daily (BID)

Drug: NE3107

Placebo

PLACEBO COMPARATOR

One 20 mg capsule containing placebo taken by mouth twice daily (BID)

Drug: Placebo

Interventions

Placebo DRUG

placebo capsule

Placebo

NE3107 DRUG

20 mg Capsule

Also known as: bezisterim

NE3107

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants ≥18 to \<70 years of age at Screening
• 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.
• PROMIS Fatigue SF13a T score ≥ 50 (≥ normative mean) after rounding to nearest integer.
• If taking medications for glycemic control at the time of Screening, must be stable on the current dosage and form for ≥ 3 months prior to randomization and expected to remain stable throughout participation in the study.
• Willing and able to provide voluntary written informed consent, complete the surveys, clinical assessments, and participate in the virtual follow-up visit at the end of the 4-week follow-up period (the End of Study visit).
• 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)
• Females taking hormone replacement therapy (HRT) must have maintained a stable regimen for at least 6 months prior to randomization and agree to continue the regimen until completing the final safety assessment in Week 16.
• Must meet one of the following criteria:
• Females: Must be postmenopausal (postmenopausal status must be confirmed as no menstrual bleeding for \>1 year, or via a follicle stimulating hormone \[FSH\] assessment at Screening), or have been surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) at least 6 months prior to Screening or agree to highly effective contraception, such as double barrier methods (e.g. condom with spermicide, IUD with spermicide). Oral contraceptives alone are insufficient.
• Males: If not vasectomized, must be abstinent or agree to use a double barrier contraception method and indicate that their partner is using highly effective birth control (as defined in 11a) until the end of the study.
• Willing to allow collection of blood for DNA methylation analysis.
• Participant has native-level proficiency in English.

You may not qualify if:

• Positive SARS-CoV-2 nucleic acid or rapid Antigen test in the past 28 days
• Received a vaccination for COVID-19 or influenza within 2 weeks of randomization
• Previous admission to the intensive care unit for COVID-19-related symptoms and/ or if intubated (i.e. mechanical ventilation) for COVID-19 care.
• Prior or active unstable or progressive major psychiatric or neurologic condition that may impact ability to determine a treatment effect and is not related to SARS-CoV-2 infection, including, but not limited to, the following examples as determined by the investigator:
• Progressive neurodegenerative disease, such as Alzheimer's disease, Parkinson's disease, etc.
• Past traumatic brain injury occurrence still associated with active post-concussive symptoms
• History of epilepsy or seizure disorder requiring ongoing treatment, or any seizure or loss of consciousness within 12 months prior to Screening
• Post-stroke deficits that may interfere with assessment, such as language or communication difficulties, aphasia, etc.
• Formal thought disorders, such as schizophrenia, psychotic bipolar disorder etc.
• Any neuropsychiatric or neurologic disorder uncontrolled for the previous six months or that may interfere with assessment, at discretion of the investigator
• Functional neurologic disorder
• Major Depressive Disorder not on stable treatment for at least 3 months prior to Screening and not planning to stay on a stable dose through the study, or a PHQ-2 score ≥ 3. (If the PHQ-2 score is ≥3 the investigator should discuss with the BioVie Medical Monitor to confirm eligibility)
• Premenstrual dysphoric disorder (PMDD)
• In the opinion of the investigator any physical, cognitive (for example intellectual disability or pre-dementia), or language impairments sufficient to adversely affect data derived from cognitive assessments.
• Diagnosed reading disability or dyslexia, or clinically significant learning disorder by history.

Sponsors & Collaborators

• BioVie Inc.: lead

Study Sites (20)

Stanford University

Palo Alto, California, 94304, United States

Location

UCSF

San Francisco, California, 94110, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Clinical Trial Site

Jacksonville, Florida, 32258, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Illinois Research Network University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Norton Infectious Disease Institute

Louisville, Kentucky, 40202, United States

Location

Jadestone Clinical Research

Silver Spring, Maryland, 20904, United States

Location

Clinical Trial Site

Farmington Hills, Michigan, 48334, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

University of Texas health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Chronicle Bio Inc.

Park City, Utah, 84119, United States

Location

Swedish Center for Research and Innovation

Seattle, Washington, 98104, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Links

• ADDRESSLC Study website

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Fatigue; Mental Fatigue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavioral Symptoms; Behavior

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): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)