NCT04438967

Brief Summary

This is a nationwide research program to study the neurological effects of COVID-19. It is open to the public. Healthy individuals and individuals who are or have been infected with COVID-19 are encouraged to join the effort. The study can be done at home with internet access and an iPad or iPhone. Participation takes about one hour. To learn more, go to https://www.mirohealth.com/consent/

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
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

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 15, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

June 15, 2020

Last Update Submit

January 4, 2021

Conditions

Keywords

COVID-19neurocognitivestrokenervous system

Outcome Measures

Primary Outcomes (2)

  • Test the hypothesis that COVID-19 infection will lead to increased risk of neurological impairment

    Each participant's Risk Score of mild cognitive impairment will be calculated using machine learning methods on a percent range of 0-100%. Miro Mobile Assessments will measure each individual's functional performance in neurocognitive, neurobehavioral, motor, and emotional domains. Miro Mobile is a clinically-validated iPad application in use by Johns Hopkins and other research centers. Miro Questionnaires will gather each individual's demographic data. To learn more, go to https://www.mirohealth.com/consent/ Miro Functional Assessments evaluate: Attention Executive function Learning and Memory Motor function Processing speed Speech and language Visuospatial function

    ~1 year

  • Determine cognitive and behavioral functional patterns that predict susceptibility to neurological impairment due to COVID-19

    Miro Questionnaires will gather each individual's demographic and medical history data. Miro Mobile Assessments will measure each individual's CNS functional performance. From this data, Miro will test the hypothesis that health indicators exist that can predict the likelihood of a COVID-19 infection leading to neurological impairment. Miro Functional Assessments evaluate: Attention Executive function Learning and Memory Motor function Processing speed Speech and language Visuospatial function

    ~1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population is open to anyone over the age of 18 who can consent for themself.

You may qualify if:

  • years of age or older
  • Access to an iPad bought in 2013 or later
  • Access to stable Wi-Fi
  • Access to iTunes

You may not qualify if:

  • Below age 18
  • Preexisting neurological, psychiatric, or developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miro Health

San Francisco, California, 94107, United States

RECRUITING

Related Links

MeSH Terms

Conditions

COVID-19StrokeNeurologic Manifestations

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natasha Belfor, PhD

    Miro Health

    PRINCIPAL INVESTIGATOR
  • Leah Rubin, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Belfor, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 19, 2020

Study Start

June 16, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Locations