A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults With Long COVID
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Clinical Trial Site
NOT_YET_RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Aurora
Florida
Clinical Trial Site
RECRUITING
Jacksonville
Georgia
Centricity Research
RECRUITING
Columbus
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Illinois Research Network University of Illinois at Chicago
RECRUITING
Chicago
Kentucky
Norton Infectious Disease Institute
RECRUITING
Louisville
Maryland
Jadestone Clinical Research
RECRUITING
Silver Spring
Michigan
Clinical Trial Site
RECRUITING
Farmington Hills
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Texas
Zenos Clinical Research
RECRUITING
Dallas
University of Texas health Science Center at San Antonio
RECRUITING
San Antonio
West Virginia
West Virginia University
RECRUITING
Morgantown
Contact Information
Primary
Penelope Markham, PhD
pmarkham@bioviepharma.com
Time Frame
Start Date:2025-04-29
Estimated Completion Date:2026-01
Participants
Target number of participants:208
Treatments
Experimental: NE3107
One 20 mg capsule containing NE3107 taken by mouth twice daily (BID)
Placebo_comparator: Placebo
One 20 mg capsule containing placebo taken by mouth twice daily (BID)