NE3107 in Adults With 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 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

More Details

NCT ID
NCT06847191
Status
Not yet recruiting
Sponsor
BioVie Inc.

Study Contact

Penelope Markham, PhD
pmarkham@bioviepharma.com