Prognostication of Recovery in Early Disorders of Consciousness After COVID-19
PREDICT-COVID
1 other identifier
observational
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2022
CompletedApril 4, 2023
April 1, 2023
1.8 years
July 16, 2020
April 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Disability Rating Scale score
Functional outcome measure. Maximum score of 29 represents high disability, minimum score of 0 represents no disability. Higher scores represent higher level of disability.
6 months
Study Arms (1)
COVID-19 Disorders of Consciousness
Patients with COVID-19 and disorders of consciousness
Interventions
measurement of functional brain networks
Eligibility Criteria
Survivors of severe COVID-19 who have disorders of consciousness
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
Fischer D, Threlkeld ZD, Bodien YG, Kirsch JE, Huang SY, Schaefer PW, Rapalino O, Hochberg LR, Rosen BR, Edlow BL. Intact Brain Network Function in an Unresponsive Patient with COVID-19. Ann Neurol. 2020 Oct;88(4):851-854. doi: 10.1002/ana.25838. Epub 2020 Aug 6.
PMID: 32613682RESULTFischer D, Snider SB, Barra ME, Sanders WR, Rapalino O, Schaefer P, Foulkes AS, Bodien YG, Edlow BL. Disorders of Consciousness Associated With COVID-19: A Prospective Multimodal Study of Recovery and Brain Connectivity. Neurology. 2022 Jan 18;98(3):e315-e325. doi: 10.1212/WNL.0000000000013067. Epub 2021 Dec 3.
PMID: 34862317DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurocritical Care Faculty
Study Record Dates
First Submitted
July 16, 2020
First Posted
July 20, 2020
Study Start
July 1, 2020
Primary Completion
April 7, 2022
Study Completion
April 7, 2022
Last Updated
April 4, 2023
Record last verified: 2023-04