A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults With Long COVID
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:
The trial drug Bezisterim (NE3107), is a new investigational drug that may help reduce certain kinds of inflammation present in Long COVID that cause impaired cognition and fatigue. Bezisterim may work by blocking production of substances that cause inflammation through toll-like receptors (TLR) pathways known to cause issues in Long COVID.
Currently bezisterim is also in clinical development for Alzheimer’s and Parkinson’s diseases, two neurodegenerative diseases where inflammation causes neurologic symptoms and cognitive decline. This trial is testing whether bezisterim can improve cognitive function or brain fog and fatigue in individuals with Long COVID.
Locations
Eligibility Criteria
Outcome
Change in performance on the Cogstate Cognition battery
Sponsor
BioVie, Inc.
Links
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
The trial drug Bezisterim (NE3107), is a new investigational drug that may help reduce certain kinds of inflammation present in Long COVID that cause impaired cognition and fatigue. Bezisterim may work by blocking production of substances that cause inflammation through toll-like receptors (TLR) pathways known to cause issues in Long COVID.
Currently bezisterim is also in clinical development for Alzheimer’s and Parkinson’s diseases, two neurodegenerative diseases where inflammation causes neurologic symptoms and cognitive decline. This trial is testing whether bezisterim can improve cognitive function or brain fog and fatigue in individuals with Long COVID.
Locations
- San Francisco, California
- Aurora, Colorado
- Jacksonville, Florida
- Columbus, Georgia
- Chicago, Illinois
- Silver Spring, Maryland
- Farmington Hills, Michigan
- Cleveland, Ohio
- Dallas, Texas
- San Antonio, Texas
- Morgantown, West Virginia
Eligibility Criteria
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
- One 20 mg capsule containing NE3107 taken by mouth twice daily (BID)
- One 20 mg capsule containing placebo taken by mouth twice daily (BID)
Outcome
Change in performance on the Cogstate Cognition battery
Sponsor
BioVie, Inc.
Links
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