What this trial measures

• Change from Baseline in performance on the Cogstate Cognition battery*12 Weeks

  \*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.

• Change from Baseline in PROMIS Cognitive Function Short Form 8a (SF-8a)12 Weeks

  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.

• Change from Baseline in PROMIS Fatigue Short Form 13a (SF-13a)12 Weeks

  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

• Change from Baseline in PROMIS Sleep Disturbance Short Form 8a (SF-8a)12 Weeks

  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.

• Change from Baseline in SF-12 Health Survey (Physical Component Scores)12 Weeks

  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

• Change from Baseline in SF-12 Health Survey (Mental Component Scores)12 Weeks

  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

• Change from Baseline in DePaul Symptom Questionnaire (DSQ) Post-Exertional Malaise12 Weeks

  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.

• Composite Benefit Score12 Weeks

  Composite Benefit Score (CBS), Composite endpoint consisting of clinically relevant symptom measures. Lower scores indicate improvement in Long COVID symptoms.