Covid19PREDICT-COVIDNCT04476589
Prognostication of Recovery in Early Disorders of Consciousness After COVID-19
An observational study of Covid19 and Coma, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Coma, Consciousness Disorder
- What is being tested?
- Functional MRI
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 7 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Survivors of severe COVID-19 who have disorders of consciousness
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Covid19, Coma, Consciousness Disorder
- Being tested
- Functional MRI
- Medical subject headings
- COVID-19, Coma, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRIDiagnostic test
measurement of functional brain networks
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Disorders of Consciousness | Patients with COVID-19 and disorders of consciousness Receives: Diagnostic Test: Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jul 2020
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian L. Edlow, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476589
- Sponsor's protocol ID
- 2020P001616
- Acronym
- PREDICT-COVID
- Status last verified
- Apr 2023
- First submitted
- 16 Jul 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32613682Fischer 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.
PubMed 34862317
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostication of Recovery in Early Disorders of Consciousness After COVID-19
- ClinicalTrials.gov ID
- NCT04476589
- Acronym / sponsor ID
- PREDICT-COVID / 2020P001616
- Conditions
- Covid19, Coma, Consciousness Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Disorders of Consciousness | – | Diagnostic Test: Functional MRIPatients with COVID-19 and disorders of consciousness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Survivors of severe COVID-19 who have disorders of consciousness
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRImeasurement of functional brain networks | Diagnostic test | COVID-19 Disorders of Consciousness |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Results publication: PubMed 32613682Fischer 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.
- Derived from this study: PubMed 34862317Fischer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Coma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability Rating Scale score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04476589, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.