COVID Long-HaulNCT06208943
Neural and Cognitive Consequences of COVID-19 Survival
An observational study of COVID Long-Haul and COVID-19, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The novel coronavirus SARS-CoV-2 infection, COVID, continues to rage throughout the world with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). This translates to millions of people surviving COVID19 infection. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID Long-Haul, COVID-19, COVID-19 Pandemic
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Sep 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals 18-70 years old who were diagnosed with COVID-19 at least 3 months ago.
Who may be able to join
- Our studies require some in-person visits to our research lab, located at 42nd Ave and Clement St in San Francisco.
- Because this study includes an MRI, part of the screening process will be to ensure you don't have any metal in your body, you do not have head or neck tattoos, and you are comfortable inside the MRI scanner.
- 18-70 years with a confirmed COVID infection at least 3 months ago.
- Negative metal screen for MRI safety
- Normal (or corrected to normal) vision
Who cannot join
- Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive symptoms)
- Loss of consciousness (LOC) greater than 30 minutes or any LOC with neurologic symptoms
- Major medical conditions (e.g., seizures disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology)
- Substance dependence, within the past year, or failed urine toxicology on the day of neuroimaging sessions
- Known claustrophobia
- Current pregnancy
- IQ estimate < 70
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Francisco Heathcare System
San Francisco, California, 94121
Kaitlyn L Dal Bon, BA, 415-629-9514, kaitlyn.dalbon@ucsf.edu
Judith M Ford, PhD
About this study
The novel coronavirus SARS-CoV-2 infection, COVID, continues to rage throughout the world with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). This translates to millions of people surviving COVID19 infection. While the lungs are ground zero, COVID tears through organ systems from brain to blood vessels. We are now beginning to see people recover but complain of ongoing problems, including lingering cognitive problems, depression, and anxiety. We have brought together 2 laboratories with complementary techniques including psychological testing and neuroimaging methods togethers with markers in the blood that may signal damage in the brain. A close look at these problems is timely and imperative if we are to understand the pathophysiology of 'COVID brain' and prepare for downstream problems.
Read the detailed description
The SARS-CoV-2 pandemic has been going on for over a year worldwide, with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). We are seeing people recover from the initial COVID infection with complaints of ongoing problems. An increasing number of people are complaining of cognitive deficits and depression/anxiety.
Methodologically, we have brought together two laboratories studying neurocognitive impairment using an EEG, MRI, and behavioral approach as well as laboratory-based data. This study queries neuropsychological functions in individuals using a neuropsychological battery, EEG-based measures, functional MRI (connectivity) and structural MRI (gray and white matter volumes, myelin, micro-bleeds). In addition, we have preliminary data to show a continued increase in plasma cytokines in COVID survivors. Plasma isolated neuronal enriched extracellular vesicles (nEVs) showed an increase in amyloid beta, neurofilament light and pT181-Tau, all proteins associated with neurodegeneration.
The overall aim is to determine the extent of cognitive, clinical, and neurological damage in people recovered from COVID.
- Conditions
- COVID Long-Haul, COVID-19, COVID-19 Pandemic, Brain Fog, Memory Deficits, Concentration Ability Impaired
- Being tested
- cross-sectional MRI and EEG assessments (NO INTERVENTION)
- Keywords
- EEG, fMRI, MRI, functional MRI, brain fog, long COVID, fatigue, difficulty concentrating, memory difficulty
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Mental Fatigue, Memory Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectional MRI and EEG assessments (NO INTERVENTION)Other
Also called cross-sectional MRI and EEG assessments
n/a there is no intervention in this observational study
| Study group | Role | What they receive |
|---|---|---|
| NeuroCOVID Group | Individuals (ages 18-70 years) who endorse a reported change in concentration, memory, feelings anxiety or depression since initial COVID infection. Receives: Other: cross-sectional MRI and EEG assessments (NO INTERVENTION) | |
| COVID Control Group | Individuals (ages 18-70 years) who do not feel any different since recovering from initial COVID infection. Receives: Other: cross-sectional MRI and EEG assessments (NO INTERVENTION) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Neuropsychological Test Performance
We will compare NP test performance in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Measured: 1 month
Number of Participants with EEG Latency & Amplitude
We will compare EEG-derived event related potential measures of neural speed in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Measured: 1 month
Number of Participants with MRI Functional Disconnectivity
We will compare thalamo-cortical connectivity in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Measured: 1 month
Number of Participants with Blood Biomarkers
We will correlate blood biomarkers of inflammation and NP test performance, thalamo-cortical connectivity, and measures of neural speed.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Oct 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID Long-HaulStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Judith Ford, San Francisco Veterans Affairs Medical Center
- Investigators
- Judith M Ford, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208943
- Sponsor's protocol ID
- CX002322
- Status last verified
- Apr 2024
- First submitted
- 11 Jan 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not part of currently approved protocol or original agreement with sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Cognitive Consequences of COVID-19 Survival
- ClinicalTrials.gov ID
- NCT06208943
- Acronym / sponsor ID
- CX002322
- Conditions
- COVID Long-Haul, COVID-19, COVID-19 Pandemic, Brain Fog, Memory Deficits, Concentration Ability Impaired
- Keywords
- EEG, fMRI, MRI, functional MRI, brain fog, long COVID, fatigue, difficulty concentrating
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 17 Jan 2024 (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 novel coronavirus SARS-CoV-2 infection, COVID, continues to rage throughout the world with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). This translates to millions of people surviving COVID19 infection. While the lungs are ground zero, COVID tears through organ systems from brain to blood vessels. We are now beginning to see people recover but complain of ongoing problems, including lingering cognitive problems, depression, and anxiety. We have brought together 2 laboratories with complementary techniques including psychological testing and neuroimaging methods togethers with markers in the blood that may signal damage in the brain. A close look at these problems is timely and imperative if we are to understand the pathophysiology of 'COVID brain' and prepare for downstream problems.
Detailed description
The SARS-CoV-2 pandemic has been going on for over a year worldwide, with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). We are seeing people recover from the initial COVID infection with complaints of ongoing problems. An increasing number of people are complaining of cognitive deficits and depression/anxiety.
Methodologically, we have brought together two laboratories studying neurocognitive impairment using an EEG, MRI, and behavioral approach as well as laboratory-based data. This study queries neuropsychological functions in individuals using a neuropsychological battery, EEG-based measures, functional MRI (connectivity) and structural MRI (gray and white matter volumes, myelin, micro-bleeds). In addition, we have preliminary data to show a continued increase in plasma cytokines in COVID survivors. Plasma isolated neuronal enriched extracellular vesicles (nEVs) showed an increase in amyloid beta, neurofilament light and pT181-Tau, all proteins associated with neurodegeneration.
The overall aim is to determine the extent of cognitive, clinical, and neurological damage in people recovered from COVID.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroCOVID Group | – | Other: cross-sectional MRI and EEG assessments (NO INTERVENTION)Individuals (ages 18-70 years) who endorse a reported change in concentration, memory, feelings anxiety or depression since initial COVID infection. |
| COVID Control Group | – | Other: cross-sectional MRI and EEG assessments (NO INTERVENTION)Individuals (ages 18-70 years) who do not feel any different since recovering from initial COVID infection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals 18-70 years old who were diagnosed with COVID-19 at least 3 months ago.
Key inclusion criteria (5 listed)
- Our studies require some in-person visits to our research lab, located at 42nd Ave and Clement St in San Francisco.
- Because this study includes an MRI, part of the screening process will be to ensure you don't have any metal in your body, you do not have head or neck tattoos, and you are comfortable inside the MRI scanner.
- 18-70 years with a confirmed COVID infection at least 3 months ago.
- Negative metal screen for MRI safety
- Normal (or corrected to normal) vision
Key exclusion criteria (7 listed)
- Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive symptoms)
- Loss of consciousness (LOC) greater than 30 minutes or any LOC with neurologic symptoms
- Major medical conditions (e.g., seizures disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology)
- Substance dependence, within the past year, or failed urine toxicology on the day of neuroimaging sessions
- Known claustrophobia
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 |
|---|---|---|
| cross-sectional MRI and EEG assessments (NO INTERVENTION)Also: cross-sectional MRI and EEG assessmentsn/a there is no intervention in this observational study | Other | COVID Control Group, NeuroCOVID Group |
Primary outcome
Change of Neuropsychological Test Performance
Time frame: 1 month
We will compare NP test performance in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Number of Participants with EEG Latency & Amplitude
Time frame: 1 month
We will compare EEG-derived event related potential measures of neural speed in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Number of Participants with MRI Functional Disconnectivity
Time frame: 1 month
We will compare thalamo-cortical connectivity in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Number of Participants with Blood Biomarkers
Time frame: 1 month
We will correlate blood biomarkers of inflammation and NP test performance, thalamo-cortical connectivity, and measures of neural speed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No. Not part of currently approved protocol or original agreement with sponsor.
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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.
Judith M Ford, PhD principal investigator
University of California, San Francisco
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 COVID Long-Haul and COVID-19, run by San Francisco Veterans Affairs Medical Center 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaitlyn L Dal Bon, BA ((415) 629-9514, kaitlyn.dalbon@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Neuropsychological Test Performance (time frame: 1 month). The study lists 4 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 12 Apr 2024.