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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

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

ArmDescriptionAssigned Intervention
Experimental
NE3107 		One 20 mg capsule containing NE3107 taken by mouth twice daily (BID)
  • Drug: NE3107
    20 mg Capsule
    Other names:
    • bezisterim
Placebo Comparator
Placebo 		One 20 mg capsule containing placebo taken by mouth twice daily (BID)
  • Drug: Placebo
    placebo capsule

Recruiting Locations

Stanford University
Palo Alto 5380748, California 5332921 94304
Contact:
Yasmin Jazayeri
yasmin98@stanford.edu

UCSF
San Francisco 5391959, California 5332921 94110
Contact:
Emily Fehrman
emily.fehrman2@ucsf.edu

University of Colorado
Aurora 5412347, Colorado 5417618 80045
Contact:
Jeffrey McKeehan
jeffrey.mckeehan@cuanschutz.edu

Yale University
New Haven 4839366, Connecticut 4831725 06519
Contact:
Kelly Benson-Atwood
kelly.benson-atwood@yale.edu

Clinical Trial Site
Jacksonville 4160021, Florida 4155751 32258
Contact:
Kyalon Graves
904-680-2818
Kgraves@greenleafclinicaltrials.com

Centricity Research
Columbus 4188985, Georgia 4197000 31904
Contact:
Grayson Scott

Illinois Research Network University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60608
Contact:
Andrea Wendrow
awendrow@uic.edu

Northwestern University
Chicago 4887398, Illinois 4896861 60611

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Slyn Uaroon
Slyn-Uaroon@uiowa.edu

Norton Infectious Disease Institute
Louisville 4299276, Kentucky 6254925 40202
Contact:
Jayne Carwile
502-629-3406
jayne.carwile@nortonhealthcare.org

Jadestone Clinical Research
Silver Spring 4369596, Maryland 4361885 20904
Contact:
Lisa Nguyen
240-429-4337
lisa.nguyen@jadestonecr.com

Clinical Trial Site
Farmington Hills 4992523, Michigan 5001836 48334
Contact:
Denise Morgott
Denise.Morgott@questri.com

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Contact:
Sara Seegmiller
seegmiller.sara@mayo.edu

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Maria Wang
mariaantonia.wang@mssm.edu

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Danielle Labbato
216-844-2739
Danielle.Labbato@UhHospitals.org

Zenos Clinical Research
Dallas 4684888, Texas 4736286 75230
Contact:
Erik Gonzalez
469-949-4900
egonzalez@allianceclinicalnetwork.com

University of Texas health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Hillary Johnson
210-450-7612
idclinicalresearch@uthsca.edu

Swedish Center for Research and Innovation
Seattle 5809844, Washington 5815135 98104
Contact:
RDResearch@providence.org

West Virginia University
Morgantown 4815352, West Virginia 4826850 26506
Contact:
Paige Harman
304-581-1913
Paige.Harman@hsc.wvu.edu

More Details

NCT ID
NCT06847191
Status
Recruiting
Sponsor
BioVie Inc.

Study Contact

Penelope Markham, PhD
pmarkham@bioviepharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.