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Open-label, Post-marketing, Prospective Study to Assess Impact of COVID-19 on Cognitive Function in Patients

NCT04950673 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-06-22

No results posted yet for this study

Summary

The objective of this study is to compare the impact of the coronavirus disease (SARS-CoV-2, or COVID-19) on cognitive function in the population of patients who have been diagnosed, treated and recovered from the COVID-19 infection versus patients who have not been infected. Primary endpoint is to evaluate the percentage of cognitive decline observed in both study arms (subjects with or without COVID-19 history) using assessments of Cognivue Clarity, MMSE and MoCA. Secondary endpoint is to see the correlation of Depression and anxiety scales (i.e., Patient Health Questionnaire-9 (PHQ-9) and/or Geriatric Depression Scale (GDS)) and Cognivue scores while comparing the trend of difference between both study arms.

Conditions

  • Cognitive Decline
  • Cognitive Dysfunction
  • Brain Health
  • Post CoV-2 Syndrome
  • COVID Long-Haul

Interventions

DEVICE

Cognivue

Computerized Cognitive Assessment Device

Sponsors & Collaborators

  • Kaweah Delta District Hospital

    collaborator UNKNOWN

  • Riiid Research LLC

    collaborator UNKNOWN

  • UH, Cleveland Medical Center

    collaborator UNKNOWN

  • US Medical Care INC

    collaborator UNKNOWN

  • Cognivue, Inc.

    lead INDUSTRY

Principal Investigators

  • Diego Cahn-Hidalgo, MD · Cognivue, Inc.

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2023-11-30
Completion
2024-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04950673 on ClinicalTrials.gov