PREDICT-COVID: Prognostication of Recovery in Early Disorders of Consciousness After COVID-19

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Suspended

CT.gov ID

NCT04476589

Collaborator

(none)

100

Enrollment

Location

32.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this research proposal is to use multimodal metrics (e.g., clinical data and advanced neuroimaging) in the early (i.e., acute hospitalization) phase of recovery from COVID-19-related disorders of consciousness to predict outcome at 3, 6, and 12 months post-hospitalization. We aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Coma Consciousness Disorder	Diagnostic Test: Functional MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prognostication of Recovery in Early Disorders of Consciousness After COVID-19

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 Disorders of Consciousness Patients with COVID-19 and disorders of consciousness	Diagnostic Test: Functional MRI measurement of functional brain networks

Arm

Intervention/Treatment

COVID-19 Disorders of Consciousness

Patients with COVID-19 and disorders of consciousness

Diagnostic Test: Functional MRI

measurement of functional brain networks

Outcome Measures

Primary Outcome Measures

Disability Rating Scale score [6 months]
Functional outcome measure. Maximum score of 29 represents high disability, minimum score of 0 represents no disability. Higher scores represent higher level of disability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

age 18 or older,
positive diagnosis of COVID-19,
diagnosis of coma, vegetative state or minimally conscious state per Glasgow Coma Scale (GCS) at time of enrollment (excluding confounders such as sedation) and
clinical team plan for an MRI for clinical management.

Exclusion Criteria:

A subject with any of the following MRI contraindications will not be eligible for this study:

electrical implants such as cardiac pacemakers or perfusion pumps
ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
ferromagnetic objects such as jewelry or metal clips in clothing that cannnot be easily removed for scanning
pregnant volunteers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brian L. Edlow, M.D., Neurocritical Care Faculty, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT04476589

Other Study ID Numbers:

2020P001616

First Posted:

Jul 20, 2020

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Consciousness Disorders

Study Results

No Results Posted as of Sep 21, 2021