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
Not Provided
Drug: NE3107
20 mg Capsule
Other Name: bezisterim
Drug: Placebo
placebo capsule
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
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
Penelope Markham, PhD
pmarkham@bioviepharma.com
Not Provided