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

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.

Completed

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Key information

Conditions

Covid19 COVID-19 Coma Consciousness Disorder Consciousness Disorders Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Unconsciousness Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional MRI

Diagnostic Test

measurement of functional brain networks

Primary outcomes

Disability Rating Scale score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: PREDICT-COVID

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jul 20, 2020
Registry last updated: Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed