NE3107 in Adults With Neurological Symptoms of Long COVID

NCT ID: NCT06847191

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-29

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long COVID

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The participant, investigator, assessors, or any member of the study staff at the CRO or sponsor will be masked to the treatment assignments.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NE3107

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

Group Type EXPERIMENTAL

NE3107

Intervention Type DRUG

20 mg Capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NE3107

20 mg Capsule

Intervention Type DRUG

Placebo

placebo capsule

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

bezisterim

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years to 64 years of age
* diagnosed with Long COVID with symptoms of fatigue and brain fog for at least 3 months
* agree to use birth control measures
* provide voluntary consent
* willing to allow blood collection
* pass all screening tests and procedures

Exclusion Criteria

* has received a COVID-19 vaccination within 30 days
* previous admission to the intensive care unit for COVID-19
* medical history of major mental or physical illness prior to COVID-19 infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioVie Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Trial Site

San Francisco, California, United States

Site Status NOT_YET_RECRUITING

University of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Clinical Trial Site

Jacksonville, Florida, United States

Site Status RECRUITING

Centricity Research

Columbus, Georgia, United States

Site Status RECRUITING

Illinois Research Network University of Illinois at Chicago

Chicago, Illinois, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Norton Infectious Disease Institute

Louisville, Kentucky, United States

Site Status RECRUITING

Jadestone Clinical Research

Silver Spring, Maryland, United States

Site Status RECRUITING

Clinical Trial Site

Farmington Hills, Michigan, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Zenos Clinical Research

Dallas, Texas, United States

Site Status RECRUITING

University of Texas health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

West Virginia University

Morgantown, West Virginia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Penelope Markham, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chloe Pitsch

Role: primary

303-724-6080

Kyalon Graves

Role: primary

904-680-2818

Grayson Scott

Role: primary

Role: backup

Andrea Wendrow

Role: primary

Cody Poe

Role: primary

319-356-1707

Jayne Carwile

Role: primary

502-629-3406

Lisa Nguyen

Role: primary

240-429-4337

Denise Morgott

Role: primary

Danielle Labbato

Role: primary

216-844-2739

Erik Gonzalez

Role: primary

469-949-4900

Hillary Johnson

Role: primary

210-450-7612

Paige Harman

Role: primary

304-581-1913

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDMRP-PR230631

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NE3107-LC-201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of CT1812 Treatment on Brain Synaptic Density
NCT03493282 COMPLETED PHASE1/PHASE2
Simvastatin for mTBI
NCT01952288 COMPLETED PHASE4