NE3107 in Adults With Neurological Symptoms of Long COVID
Purpose
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
Condition
- Long COVID
Eligibility
- Eligible Ages
- Between 18 Years and 69 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- The participant, investigator, assessors, or any member of the study staff at the CRO or sponsor will be masked to the treatment assignments.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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) |
|
Recruiting Locations
University of Colorado
Aurora, Colorado 80045
Aurora, Colorado 80045
Yale University
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Clinical Trial Site
Jacksonville, Florida 32258
Jacksonville, Florida 32258
Centricity Research
Columbus, Georgia 31904
Columbus, Georgia 31904
Contact:
Grayson Scott
Grayson Scott
Illinois Research Network University of Illinois at Chicago
Chicago, Illinois 60608
Chicago, Illinois 60608
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Norton Infectious Disease Institute
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Jadestone Clinical Research
Silver Spring, Maryland 20904
Silver Spring, Maryland 20904
Clinical Trial Site
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Zenos Clinical Research
Dallas, Texas 75230
Dallas, Texas 75230
University of Texas health Science Center at San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
Chronicle Bio Inc.
Park City, Utah 84119
Park City, Utah 84119
Swedish Center for Research and Innovation
Seattle, Washington 98104
Seattle, Washington 98104
West Virginia University
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
More Details
- NCT ID
- NCT06847191
- Status
- Recruiting
- Sponsor
- BioVie Inc.