NE3107 in Adults With Neurological Symptoms of Long COVID

Phase 2RecruitingNCT06847191

BioVie Inc.208 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

208

Conditions

Long COVID

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (20)

Stanford University

Palo Alto, California, United States

RECRUITING

UCSF

San Francisco, California, United States

RECRUITING

University of Colorado

Aurora, Colorado, United States

RECRUITING

Yale University

New Haven, Connecticut, United States

RECRUITING

Clinical Trial Site

Jacksonville, Florida, United States

RECRUITING

Centricity Research

Columbus, Georgia, United States

RECRUITING

Illinois Research Network University of Illinois at Chicago

Chicago, Illinois, United States

RECRUITING

Northwestern University

Chicago, Illinois, United States

RECRUITING

University of Iowa

Iowa City, Iowa, United States

RECRUITING

Norton Infectious Disease Institute

Louisville, Kentucky, United States

RECRUITING

...and 10 more locations

Outcomes

Primary Outcomes

Change from Baseline in performance on the Cogstate Cognition battery

Objective computerized neurocognitive testing assessing attention, sustained attention, verbal memory, verbal learning, psychomotor function and processing speed. A composite cognitive score is calculated as the mean of standardized (z-score-transformed) performance scores across the tasks. Higher composite scores indicate better cognitive performance.

Time frame: 12 Weeks

Secondary Outcomes

Change from Baseline in PROMIS Cognitive Function Short Form 8a (SF-8a)

Patient-reported assessment of perceived cognitive abilities, including memory, attention, and mental acuity. Scores are standardized T-scores, T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores below 50 represent worse cognitive function.

Time frame: 12 Weeks

Change from Baseline in PROMIS Fatigue Short Form 13a (SF-13a)

The PROMIS Fatigue SF-13a assesses patient-reported fatigue severity and impact over the prior 7 days. Scores are standardized T-scores, T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent worse fatigue severity

Time frame: 12 Weeks

Change from Baseline in PROMIS Sleep Disturbance Short Form 8a (SF-8a)

Patient-reported measure of sleep quality, depth, and restoration. Scores are standardized T scores and T scores are a continuous variable. The mean in the general population 50 (SD=10), with higher scores reflecting greater sleep disturbance.

Time frame: 12 Weeks

Change from Baseline in SF-12 Health Survey (Physical and Mental Component Scores)

Generic quality-of-life assessment evaluating physical (PCS) and mental (MCS) health domains

Time frame: 12 Weeks

Change from Baseline in DePaul Symptom Questionnaire (DSQ) Post-Exertional Malaise (PEM

DSQ-PEM evaluates the presence or absence of PEM and myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) and the severity and frequency of PEM symptoms. Participants rate both frequency and severity of PEM symptoms. Frequency is rated on a 5-point Likert scale (0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, 4 = all of the time). Severity is rated on a 5-point Likert scale (0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). Post-exertional malaise is considered present if the participant reports at least one PEM symptom with a severity score ≥2 (moderate or greater) and a frequency score ≥2 (about half the time or more). The outcome measure is the change from baseline in the exercise intolerance symptom cluster score derived from the DSQ-PEM.

Time frame: 12 Weeks

NE3107 in Adults With Neurological Symptoms of Long COVID

Overview

Conditions

Interventions

Eligibility

Locations (20)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts