NE3107 in Adults With Neurological Symptoms of Long COVID

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Long COVID

In brief

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

Key facts

Study ID

NCT06847191

Run by

BioVie Inc.

People needed

203

Starts

2025-04-29

Expected to finish

2026-09-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult participants ≥18 to <70 years of age at Screening
• Long COVID with neurological symptoms as defined below:
• 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.
• Symptoms cannot be explained by any concomitant condition or diagnosis, in the opinion of the investigator.
• Symptom duration for at least 3 months.
• PROMIS Cognitive Function SF8a T score ≤ 40 (≥ 1 SD below normative mean) after rounding to nearest integer. If the T score is marginally exclusionary, a subject may be allowed following discussion between the investigator and BioVie Medical Monitor.
• 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.
• Documented attention deficit hyperactivity disorder (ADHD) being treated with psychostimulants. Individuals diagnosed with ADHD being treated with non-stimulants must be stable on the current dosage for ≥ 3 months prior to randomization and expected to remain stable throughout participation in the study.
• Known active bacterial, fungal, viral, or other infection besides SARS-CoV-2 requiring treatment within 28 days prior to randomization and meeting criteria for systemic involvement upon review by the site investigator. Note: Mild or limited infections such as uncomplicated urinary tract or yeast infections, sexually transmitted infections, and mild dermatophyte infections may be reviewed with the study investigator but are not exclusionary.
• Diagnosis of narcolepsy.
• History of obstructive sleep apnea unless the participant is compliant with prescribed treatment (e.g., CPAP or BiPAP therapy) as confirmed by medical records or clinician assessment.
• History of congestive heart failure suspected or known dissecting aneurysm, recent systemic or pulmonary embolus or myocardial infarction (≤ 6 months), severe valvular heart disease, ventricular aneurysm, active or suspected myocarditis or pericarditis, thrombophlebitis or intracardiac thrombi.
• Electrocardiogram with clinically significant findings as assessed by the Investigator. Note: Below are the examples of clinically significant ECG abnormalities:
• Previous documented evidence of myocardial infarction or recent significant change in the resting ECG suggesting infarction or other acute cardiac events.
• Current symptoms of coronary insufficiency (i.e. angina pectoris and/or ST segment depression on ECG).
• Evidence of uncontrolled atrial or frequent or complex ventricular ectopy, or myocardial conduction defect which would increase the risk of syncope (for example, second degree or higher A-V block).
• QT prolongation (QTcF >450 msec (male) or >470 msec (female) [If QTcF is marginally above these values, a subject may still be allowed on a case-by-case basis following discussion between the investigator and medical monitor].

Where it is running

• Stanford University — Palo Alto, California, United States
• UCSF — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Clinical Trial Site — Jacksonville, Florida, United States
• Centricity Research — Columbus, Georgia, United States
• Illinois Research Network University of Illinois at Chicago — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Norton Infectious Disease Institute — Louisville, Kentucky, United States
• Jadestone Clinical Research — Silver Spring, Maryland, United States
• Clinical Trial Site — Farmington Hills, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Zenos Clinical Research — Dallas, Texas, United States
• University of Texas health Science Center at San Antonio — San Antonio, Texas, United States
• Chronicle Bio Inc. — Park City, Utah, United States
• Swedish Center for Research and Innovation — Seattle, Washington, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.