Treatment Outcomes in PASC Patients With Neurocognitive Impairment

NCT07090564 | Completed

• 1 other identifier: 2022H0258
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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

Conditions

Long COVID

Keywords

Long COVID; PASC; Post-Acute Sequelae of COVID19

Outcome Measures

Primary Outcomes (2)

• Change in quality of life using PROMIS26 questionnaire

  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.

  6 months

• Change in PROMS20 T-scores

  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.

  6 months per patient

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from the Post-COVID Recovery Clinic (PCRC) at the Ohio State University Wexner Medical Center (OSUWMC) between 10/12/2022 and 10/23/2023.

You may qualify if:

• \- 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.

You may not qualify if:

• Age under 18
• Failure to complete pre-visit PROMIS29 questionnaire
• Absence of a Long COVID diagnosis or concurrent neurologic diagnosis.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43203, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: October 12, 2022
• Primary Completion: March 31, 2024
• Study Completion: April 1, 2024
• Last Updated: March 3, 2026

Record last verified: 2025-07

Locations

US (1)