NE3107 in Adults With Neurological Symptoms of Long COVID

Phase 2

Recruiting

• Conditions: Long COVID
• Interventions: Drug: NE3107; Drug: Placebo

• Registration Number: NCT06847191
• Lead Sponsor: BioVie Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-26
• Study Start: 2025-04-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NE3107	NE3107	One 20 mg capsule containing NE3107 taken by mouth twice daily (BID)
Placebo	Placebo	One 20 mg capsule containing placebo taken by mouth twice daily (BID)

Primary Outcome Measures

Name	Time	Method
Change in performance on the Cogstate Cognition battery	12 Weeks

Trial Locations

Locations (1)

Clinical Trial Site; 🇺🇸 Farmington Hills, Michigan, United States