Covid19 Clinical Trial
— PREDICT-COVIDOfficial title:
Prognostication of Recovery in Early Disorders of Consciousness After COVID-19
| NCT number | NCT04476589 |
| Other study ID # | 2020P001616 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 1, 2020 |
| Est. completion date | April 7, 2022 |
| Verified date | April 2023 |
| Source | Massachusetts General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | April 7, 2022 |
| Est. primary completion date | April 7, 2022 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. age 18 or older, 2. positive diagnosis of COVID-19, 3. diagnosis of coma, vegetative state or minimally conscious state per Glasgow Coma Scale (GCS) at time of enrollment (excluding confounders such as sedation) and 4. 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital |
United States,
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 202 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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