Treatment Outcomes in PASC Patients With Neurocognitive Impairment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Change in quality of life using PROMIS26 questionnaire
Study Overview
Brief Summary
Longitudinal study collecting retrospective and prospective data on treatments received and change in quality of life among patients with neurocognitive symptoms attending a Long COVID clinic
Detailed Description
Specific Aims:
- Characterize pre-treatment quality of life and cognitive performance data for patients with Post-Acute Sequelae of COVID19 (PASC) and neurocognitive symptoms (PASC/NCS) seen at The Ohio State University Medical Center (OSUMC)
- Describe treatment strategies deployed for these patients at the above institution.
- Compare post-treatment quality of life and cognitive outcomes to pre-treatment values for these patients.
Significance and Impact:
Since the beginning of the epidemic, there have been 79 million COVID19 cases in the United States, and 480 million globally1. COVID19 survivors can suffer substantial long-term morbidity. Post-Acute Sequelae of COVID19 (PASC) is defined as persistent symptoms occurring weeks to months after infection with SARS-CoV-22. PASC is a multisystem disease with respiratory, cardiac, neurological, rheumatologic and other manifestations. In population-based studies, about 25% of patients report not having fully recovered 6-8 months after documented SARS-CoV-2 infection3. PASC is estimated to affect as many 17 million people worldwide4.
Neurocognitive symptoms in the setting of PASC (PASC/NCS) are seen 6 months after infection in 12-22% of COVID19 survivors5-8. They are associated with hypometabolism in brain areas controlling memory and executive function on brain imaging, and with atrophy in corresponding brain areas on post-mortem studies9-11. PASC/NCS has a significant impact on quality of life and functional ability, with 63% of affected patients reporting decreased quality of life12, and nearly half of previously employed patients unable to return to full-time work after 6 months13,14. Evidence suggests similar cellular mechanisms and patterns of neural injury between PASC/NCS and traumatic brain injury15-17.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Diagnosis of Long COVID assigned by a PCRC provider and at least one of a prespecified set of ICD10 codes used by clinic providers to indicate neurologic symptoms. Since no diagnostic biomarkers or established criteria existed during the period of the study, Long COVID diagnosis was based on clinical judgement, taking into account the timing of symptom onset relative to acute COVID19 and the presence or absence of alternate diagnoses that might explain them.
Exclusion Criteria
- •Age under 18
- •Failure to complete pre-visit PROMIS29 questionnaire
- •Absence of a Long COVID diagnosis or concurrent neurologic diagnosis.
Arms & Interventions
Patients with neurocognitive symptoms receiving care at a Long COVID clinic
OSUMC started a specialized multidisciplinary PASC clinic in March of 2021 to see patients suffering from persistent symptoms after COVID19 infection. The clinic is based in the Division of General Internal Medicine. OSUMC patients have completed the PROMIS-29 inventory, which includes information on cognitive functioning, overall functional status, and impact of cognitive symptoms on QoL.
Outcomes
Primary Outcomes
Change in quality of life using PROMIS26 questionnaire
Time Frame: 6 months
The PROMIS29 is a well-validated measure of quality of life in multiple domains. Study subjects will complete PROMIS29 questionnaire at the first clinic visit, and again 6 months later. The outcome will consist of change in T-scores on the PROMIS29 from t=0 to t=6 months.
Change in PROMS20 T-scores
Time Frame: 6 months per patient
Change in quality of life from pre-treatment to 6 months after initiating multimodality treatment in Post-CIVD Recovery Clinic. The PROMIS29 is a well-validated measure of quality of life in multiple domains.
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrew Schamess
Principal Investigator
Ohio State University