Official Title
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 aCOVID-19 infection. This study aims to evaluate the effects of NE3107 on severalneurological symptoms reported in people with Long COVID including difficultyconcentrating or remembering things ("brain fog") and fatigue.Researchers will compare NE3107 to a placebo (a look-alike substance that contains nodrug) 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

Not Provided

Recruiting
Long Covid

Drug: NE3107

20 mg Capsule
Other Name: bezisterim

Drug: Placebo

placebo capsule

Eligibility Criteria

Key Inclusion Criteria:

- 18 years to 69 years of age

- Long COVID with neurological symptoms as defined below:

1. 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.

2. Symptoms cannot be explained by any concomitant condition or diagnosis, in the
opinion of the investigator.

3. Symptom duration for at least 3 months. diagnosed with Long COVID with symptoms
of fatigue and brain fog for at least 3 months

- 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)

- Agree to use birth control measures

- Provide voluntary consent

- Willing to allow blood collection

- Pass all screening tests and procedures

Key Exclusion Criteria:

- Has received a COVID-19 vaccination within 14 days

- Previous admission to the intensive care unit for COVID-19

- Medical history of major mental or physical illness prior to COVID-19 infection

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 69 Years
Countries
United States
Locations

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

Contacts

Penelope Markham, PhD
pmarkham@bioviepharma.com

Not Provided

NCT Number
Keywords
Covid-19
Neurocognition
Fatigue
Post-exertional malaise
Sleep
SARS-CoV-2
brain fog
MeSH Terms
Post-Acute COVID-19 Syndrome
COVID-19
Fatigue
Mental Fatigue