NCT06847191Phase 2Completed

NE3107 in Adults With Neurological Symptoms of Long COVID

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-08-06Actual

Enrollment · participants203Actual

Source updated2026-09-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-09-22 · 1 field changed

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Completed

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Posted 2026-08-26 · 3 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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Measure: Change from Baseline in performance on the Cogstate Cognition battery*

+ After

Measure: Change from Baseline in performance on the Cogstate Cognition battery* Measure: Change from Baseline in PROMIS Cognitive Function Short Form 8a (SF-8a) Measure: Change from Baseline in PROMIS Fatigue Short Form 13a (SF-13a) Measure: Change from Baseline in PROMIS Sleep Disturbance Short Form 8a (SF-8a) Measure: Change from Baseline in SF-12 Health Survey (Physical Component Scores) Measure: Change from Baseline in SF-12 Health Survey (Mental Component Scores) Measure: Change from Baseline in DePaul Symptom Questionnaire (DSQ) Post-Exertional Malaise Measure: Composite Benefit Score

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Aug 2026~~

+ After

6 Aug 2026

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Posted 2026-05-29 · 5 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Change from Baseline in performance on the Cogstate Cognition battery

+ After

Measure: Change from Baseline in performance on the Cogstate Cognition battery*

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~208 participants (planned)~~

+ After

203 participants (actual)

Primary completion date changed

− Before

~~Jun 2026~~

+ After

Aug 2026

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Posted 2026-02-19 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Change in performance on the Cogstate Cognition battery

+ After

Measure: Change from Baseline in performance on the Cogstate Cognition battery

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Posted 2026-01-29 · 1 field changed

Primary completion date changed

− Before

~~Nov 2025~~

+ After

Jun 2026

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Study details

Conditions studied

Long COVID

Treatments or interventions studied

NE3107DrugAlso known as bezisterim
PlaceboDrug

Primary outcomes · main study measures

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measure: Change from Baseline in performance on the Cogstate Cognition battery*; description: \*This study is designed as a signal-seeking proof-of-concept Phase 2 study. The primary outcome is intended for estimation and hypothesis generation rather than formal hypothesis testing. No single endpoint is designated as definitive for study success. Objective computerized neurocognitive testing using Cogstate battery 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.; timeFrame: 12 Weeks; measure: Change from Baseline in PROMIS Cognitive Function Short Form 8a (SF-8a); description: 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.; timeFrame: 12 Weeks; measure: Change from Baseline in PROMIS Fatigue Short Form 13a (SF-13a); description: 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; timeFrame: 12 Weeks; measure: Change from Baseline in PROMIS Sleep Disturbance Short Form 8a (SF-8a); description: 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.; timeFrame: 12 Weeks; measure: Change from Baseline in SF-12 Health Survey (Physical Component Scores); description: Generic quality-of-life assessment evaluating physical (PCS) and mental (MCS) health domains which are normalized to a mean of 50 (SD=10) with scores lower scores indicating worse physical function; timeFrame: 12 Weeks; measure: Change from Baseline in SF-12 Health Survey (Mental Component Scores); description: Generic quality-of-life assessment evaluating physical (PCS) and mental (MCS) health domains which are normalized to a mean of 50 (SD=10) with lower scores indicating worse mental health; timeFrame: 12 Weeks; measure: Change from Baseline in DePaul Symptom Questionnaire (DSQ) Post-Exertional Malaise; description: 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.; timeFrame: 12 Weeks; measure: Composite Benefit Score; description: Composite Benefit Score (CBS), Composite endpoint consisting of clinically relevant symptom measures. Lower scores indicate improvement in Long COVID symptoms.; timeFrame: 12 Weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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