Sars-CoV2NCT04496076
COVID-19 Brain Injury
An observational study of Sars-CoV2 and Severe Neurologic Injury, run by University of Pittsburgh at 1 site in United States.
Trial summary
A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2, Severe Neurologic Injury, Ischemic Stroke
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2020to 31 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with 5 select primary neurological diagnoses (Acute Ischemic Stroke, Acute Intracerebral Hemorrhage, Acute Subarachnoid Hemorrhage, Acute Traumatic Brain Injury, Status Epilepticus) requiring ICU care
Who may be able to join
- Patients greater than or equal to 18
- Patients who require critical care with primary diagnoses of: Acute ischemic stroke (AIS), acute intracerebral hemorrhage (ICH), acute subarachnoid hemorrhage (SAH), acute traumatic brain injury (TBI), status epilepticus (SE) patients requiring critical care
Who cannot join
- Patients under the age of 18 years old
- Pre-existing Do Not Resuscitate (DNR), Do Not Intubate (DNI), or Comfort Measures Only (CMO) status prior to acute hospitalization
- Neurologically morbid-bound on hospital arrival (bilateral fix/dilated pupils, catastrophic bleed/TBI) and likely to progress to brain death within 48 hrs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Severe Neurologic Injury Outcomes During COVID-19 Crisis
A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.
Read the detailed description
COVID 19 pandemic has overwhelmed healthcare capacity in many regions around the world. As resources become more limited and we have to triage /ration ventilators, neurologically injured ICU patients without COVID 19 but with respiratory insufficiency may be triaged to no ventilator care due to their perceived or actual prognosis. This may lead to increased rates of withdrawal of care and mortality. Some neurologically injured ICU patients with respiratory insufficiency may be simultaneously infected with COVID 19. Their outcomes are completely unknown. Capturing data on the prevalence of limitation of care and prognosis in this patient population will provide important information towards ongoing efforts in patient care and resource utilization as we face the rapidly evolving COVID 19 pandemic. Given the expected strain on ICU resources and limitations in research in ICUs during COVID 19 pandemic, data capture/study design must be targeted and pragmatic. This study is designed to answer the most basic and important questions while minimizing the burden of data collection on already overloaded providers.
This study design is comprised of two components: Component 1- Prospective cohort prevalence study captures data related to treatments offered, limitations of care and patient outcome in 5 select primary neurological diagnoses requiring ICU care. Component 2- Case control study captures the same data elements in the same patient populations during the 3 months prior COVID 19 pandemic (Sept - Dec, 2019).
- Conditions
- Sars-CoV2, Severe Neurologic Injury, Ischemic Stroke, Hemorrhagic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Cerebral Hemorrhage, Subarachnoid Hemorrhage, Brain Injuries, Traumatic, Status Epilepticus
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital Mortality
Measured: At hospital discharge, approximately 1 month
30-day mortality
Measured: 30 days post-hospital discharge
Secondary outcomes (2)
Limitations of patient care- Frequency of care not being provided
Care treatment such as ventilator use, intubation, and/or tracheostomy
Measured: During In-hospital course, up to 1 month
Limitations of patient care- Conversion of DNR/DNI/CMO status
Measured: During In-hospital course, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start2 Apr 2020
- Primary completion31 Mar 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Hsiang-Yi Chou, University of Pittsburgh
- Investigators
- Sherry H Chou, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496076
- Sponsor's protocol ID
- STUDY20030201
- Status last verified
- Apr 2021
- First submitted
- 13 Jul 2020
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Neurologic Injury Outcomes During COVID-19 Crisis
- ClinicalTrials.gov ID
- NCT04496076
- Acronym / sponsor ID
- STUDY20030201
- Conditions
- Sars-CoV2, Severe Neurologic Injury, Ischemic Stroke, Hemorrhagic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 3 Aug 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.
A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.
Detailed description
COVID 19 pandemic has overwhelmed healthcare capacity in many regions around the world. As resources become more limited and we have to triage /ration ventilators, neurologically injured ICU patients without COVID 19 but with respiratory insufficiency may be triaged to no ventilator care due to their perceived or actual prognosis. This may lead to increased rates of withdrawal of care and mortality. Some neurologically injured ICU patients with respiratory insufficiency may be simultaneously infected with COVID 19. Their outcomes are completely unknown. Capturing data on the prevalence of limitation of care and prognosis in this patient population will provide important information towards ongoing efforts in patient care and resource utilization as we face the rapidly evolving COVID 19 pandemic. Given the expected strain on ICU resources and limitations in research in ICUs during COVID 19 pandemic, data capture/study design must be targeted and pragmatic. This study is designed to answer the most basic and important questions while minimizing the burden of data collection on already overloaded providers.
This study design is comprised of two components: Component 1- Prospective cohort prevalence study captures data related to treatments offered, limitations of care and patient outcome in 5 select primary neurological diagnoses requiring ICU care. Component 2- Case control study captures the same data elements in the same patient populations during the 3 months prior COVID 19 pandemic (Sept - Dec, 2019).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with 5 select primary neurological diagnoses (Acute Ischemic Stroke, Acute Intracerebral Hemorrhage, Acute Subarachnoid Hemorrhage, Acute Traumatic Brain Injury, Status Epilepticus) requiring ICU care
Key inclusion criteria (2 listed)
- Patients greater than or equal to 18
- Patients who require critical care with primary diagnoses of: Acute ischemic stroke (AIS), acute intracerebral hemorrhage (ICH), acute subarachnoid hemorrhage (SAH), acute traumatic brain injury (TBI), status epilepticus (SE) patients requiring critical care
Key exclusion criteria (3 listed)
- Patients under the age of 18 years old
- Pre-existing Do Not Resuscitate (DNR), Do Not Intubate (DNI), or Comfort Measures Only (CMO) status prior to acute hospitalization
- Neurologically morbid-bound on hospital arrival (bilateral fix/dilated pupils, catastrophic bleed/TBI) and likely to progress to brain death within 48 hrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital Mortality
Time frame: At hospital discharge, approximately 1 month
30-day mortality
Time frame: 30 days post-hospital discharge
2 secondary outcomes
Limitations of patient care- Frequency of care not being provided
Time frame: During In-hospital course, up to 1 month
Limitations of patient care- Conversion of DNR/DNI/CMO status
Time frame: During In-hospital course, up to 1 month
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 16 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Sherry H Chou, MD, MSc principal investigator
University of Pittsburgh
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 Sars-CoV2 and Severe Neurologic Injury, run by University of Pittsburgh 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 2 inclusion and 3 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 16 Aug 2021. 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?
In-hospital Mortality (time frame: At hospital discharge, approximately 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2021.