NCT04950673

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

July 21, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2.4 years

First QC Date

June 30, 2021

Last Update Submit

June 21, 2022

Conditions

Cognitive DeclineCognitive DysfunctionBrain HealthPost CoV-2 SyndromeCOVID Long-Haul

Keywords

SARS-CoV2COVID19CognitionCognivueInstitutional Review Board or IRBMontreal Cognitive Assessment or MoCAMini-Mental Status Exam or MMSEPatient Health Questionnaire or PHQ-9Food Drug Administration or FDAWorld Health Organization or WHOInformed Consent Form or ICFCase Report Form or CRFGood Clinical Practice or GCPPost CoV-2 SyndromeCOVID Long-Haul

Outcome Measures

Primary Outcomes (1)

  • Cognitive decline

    The percentage of cognitive decline observed in both study arms (subjects with or without COVID-19 history) using assessments of Cognivue Clarity, Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).

    24 months

Secondary Outcomes (1)

  • Comparison between Cognivue and other paper-pencil cognitive assessment batteries

    24 months

Study Arms (2)

Subjects who had COVID-19 infection and recovered at 3 months

500 subjects who have had a history of COVID19 infection and recovered 3 months prior to the enrollment

Device: Cognivue

Subjects who never had COVID-19 infection

500 subjects who never had a history of COVID19 infection prior to the enrollment

Device: Cognivue

Interventions

CognivueDEVICE

Computerized Cognitive Assessment Device

Subjects who had COVID-19 infection and recovered at 3 monthsSubjects who never had COVID-19 infection

Eligibility Criteria

Age18 Years - 95 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmales and females
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1000 total subjects; 500 with COVID-19 history and 500 without COVID-19 diagnosis.

You may qualify if:

  • Age ≥ 18 years old
  • Male or Female
  • Previous diagnosis of COVID-19, but recovered \>3 months (Arm 1)
  • Never infected or diagnosed with COVID-19 (Arm 2)
  • Fluent in English
  • Able to operate simple computerized device
  • Willing to sign a written informed consent and ability to comply with study requirements
  • Ability to provide demographic and medical history information

You may not qualify if:

  • Individuals under 18 years old
  • Currently under COVID-19 treatment or quarantine
  • Previously known diagnosis of dementia and Alzheimer's
  • Inability to provide written informed consent for self or complete cognitive testing (either using Cognivue Clarity or paper/pencil testing)
  • Known severe terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

RiiiD Research, LLC

Irvine, California, 92618, United States

Location

Kaweah Health (Kaweah Delta District Hospital)

Visalia, California, 93291, United States

Location

US Medical Care Inc

Boca Raton, Florida, 33431, United States

Location

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionPost-Acute COVID-19 SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Diego Cahn-Hidalgo, MD

    Cognivue, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2021

First Posted

July 6, 2021

Study Start

July 21, 2021

Primary Completion

November 30, 2023

Study Completion

April 30, 2024

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

No plan to share participants' data with other researchers due to the HIPAA compliant issue

Locations

US(4)