Post-Acute COVID-19 SyndromeNCT07074158
Microbial and Cytokine Signatures in Long COVID Patients
An observational study of Post-Acute COVID-19 Syndrome, run by Palo Alto Medical Foundation at 1 site in United States.
Trial summary
We aim at identifying potential biomarkers in plasma indicative of post-acute coronavirus SARS-CoV-2 Syndrome (Long COVID). Our case-control study will compare Long COVID patients to healthy patients from Sutter Health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This study will focus on participants with a diagnosis code for long-COVID (U09.9) in their Sutter EMR and healthy controls who are Sutter Health's patients. It will enroll 75 patients diagnosed with long-COVID and 75 matched healthy controls respectively. Healthy controls will be matched 1:1 to long-COVID patients for age (+/-10 years and preferably by sex).
Who may be able to join
- ≥ 18-year-old
- English speaking (per Sutter medical records information)
- Ability and willingness to provide signed Consent Form
- Ability to comply with the study protocol
- Ability to attend the study visit, complete questionnaires, have blood collected and tested And, either Long-COVID or Healthy control as described below
- Long-COVID patient Cohort (n=75)
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- Sutter patient who is a patient from Sutter Health Holistic/Integrative Medicine clinic
- Documentation of a long-COVID diagnosis (U09.9) for patient's initial visit in clinic between 01/01/2021 and 06/30/2024.
- Presence of active and ongoing long-COVID symptoms
- Ongoing long-COVID symptoms consistently present over the previous 6 months or longer
- Presence of the following long-COVID symptoms (a, b, and c plus either d or e) affecting you more than 50% of your life:
- Fatigue that does not go away with rest.
- Post-exertional malaise ((worsening of your symptoms following cognitive, emotional, physical efforts)
- Unrefreshing sleep (sleep is not restorative)
- Brain "fog" (e.g., difficulty with finding words or mental tasks)
- Postural Orthostatic Hypotension (e.g., lightheadedness, dizziness, and/or palpitations with sitting up or standing up positions).
- Healthy controls with no Long COVID syndrome (n=75)
- Sutter Health patients
- Matched by age to a long COVID subject (+/-10 years and preferably by sex).
Who cannot join
- Pregnant or nursing woman
- Alcohol or another drug abuse ongoing within one year
- Severe depression or acute suicidal ideation
- Bipolar disorder, schizophrenia, or other psychosis
- History of malignancy, except basal cell carcinoma
- History of significant autoimmune disorder:
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- Addison disease
- Dermatomyositis
- Graves' disease
- Multiple sclerosis
- Myasthenia gravis
- Pernicious anemia
- Rheumatoid arthritis
- Sjögren syndrome
- Systemic lupus erythematosus
- Type I diabetes
- Celiac disease
- Active pulmonary infection (active pneumonia)
- Chronic kidney disease
- Chronic liver disease
- Chronic lung disease
- Pulmonary fibrosis
- Interstitial pneumonitis
- Uncontrolled asthma
- Chronic obstructive pulmonary disease (COPD)
- Reactive arthritis
- Immunocompromised conditions or weaken immune system:
- Cancer under treatment or treated within one year of enrollment
- AIDS
- Transplant patient
- Biologicals impacting the immune system
- Taking immunosuppressor
- Neurologic conditions:
- Dementia or other neurological conditions
- Acute Spinal Cord Injury
- Alzheimer's Disease
- Amyotrophic Lateral Sclerosis (ALS)
- Ataxia
- Cerebral Aneurysm diagnosed within one year of enrollment
- Epilepsy and Seizures uncontrolled with medication
- Heart conditions:
- Congestive heart failure
- Myocardial infarction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sutter Health Palo Alto Center
Palo Alto, California, 94301
About this study
Official title: Identification of Microbial and Cytokine Signatures in Long COVID Patients: A Case-control Study of Long COVID Patients With Healthy Individuals
We aim at identifying potential biomarkers in plasma indicative of post-acute coronavirus SARS-CoV-2 Syndrome (Long COVID). Our case-control study will compare Long COVID patients to healthy patients from Sutter Health.
Read the detailed description
Two measures will be obtained from participants' plasma:
- microbial signatures using Karius' agnostic metagenomic assay via microbial cell-free DNA (mcfDNA) sequencing (kariusdx.com)
- cytokine signatures using 71-plex and 18-plex assays (evetechnologies.com).
The diagnostic utility of the potential biomarkers, including signatures derived from microbial cell-free DNA fragments found in plasma and plasma cytokines, will be evaluated independently and in various combinations to determine whether and to what extent we can accurately identify Long COVID patients. Moreover, we plan to leverage the Karius Test and the underlying Karius microbial cell-free DNA technology to determine whether there is evidence of more frequent reactivations of latent infections in patients with long COVID compared to matched healthy control. Plasma samples will also be stored for future comparative studies of additional immune profiles.
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- Long COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long COVID Subjects | Long COVID patients with a duration of illness longer than 6 months or longer will be included in the study. | |
| Healthy Controls | Healthy controls, matched by age to a long COVID subject (+/-10 years and preferably by sex). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metagenomics
In this proof-of-concept study, we want to test the hypothesis that mcfDNA has diagnostic utility as a biomarker for long COVID patients by applying the agnostic metagenomic sequencing approach.
Measured: Baseline
Cytokines
Cytokine signatures have been associated with disease severity in patients with chronic fatigue syndrome (Montoya et al, Proc Natl Acad Sci U S A. 2017 Aug 22;114(34): E7150-E7158.). We want to test the hypothesis that cytokine profiles may serve as surrogate biomarkers for Long COVID.
Measured: Baseline
Metadata analysis
Analysis of microbial-cell-free DNA and cytokine to identity meta-signatures associated with Long COVID and/or Long COVID severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start14 Jul 2025 (estimated)
- Primary completion13 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose G Montoya, Principal investigator, Sutter Health, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074158
- Sponsor's protocol ID
- 2024.133EXP
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 20 Jul 2025
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Microbial and Cytokine Signatures in Long COVID Patients: A Case-control Study of Long COVID Patients With Healthy Individuals
- ClinicalTrials.gov ID
- NCT07074158
- Acronym / sponsor ID
- 2024.133EXP
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- Long COVID
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Study start
- 14 Jul 2025 (estimated)
- Primary completion
- 13 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 20 Jul 2025 (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.
We aim at identifying potential biomarkers in plasma indicative of post-acute coronavirus SARS-CoV-2 Syndrome (Long COVID). Our case-control study will compare Long COVID patients to healthy patients from Sutter Health.
Detailed description
Two measures will be obtained from participants' plasma:
- microbial signatures using Karius' agnostic metagenomic assay via microbial cell-free DNA (mcfDNA) sequencing (kariusdx.com)
- cytokine signatures using 71-plex and 18-plex assays (evetechnologies.com).
The diagnostic utility of the potential biomarkers, including signatures derived from microbial cell-free DNA fragments found in plasma and plasma cytokines, will be evaluated independently and in various combinations to determine whether and to what extent we can accurately identify Long COVID patients. Moreover, we plan to leverage the Karius Test and the underlying Karius microbial cell-free DNA technology to determine whether there is evidence of more frequent reactivations of latent infections in patients with long COVID compared to matched healthy control. Plasma samples will also be stored for future comparative studies of additional immune profiles.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long COVID Subjects | – | –Long COVID patients with a duration of illness longer than 6 months or longer will be included in the study. |
| Healthy Controls | – | –Healthy controls, matched by age to a long COVID subject (+/-10 years and preferably by sex). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will focus on participants with a diagnosis code for long-COVID (U09.9) in their Sutter EMR and healthy controls who are Sutter Health's patients. It will enroll 75 patients diagnosed with long-COVID and 75 matched healthy controls respectively. Healthy controls will be matched 1:1 to long-COVID patients for age (+/-10 years and preferably by sex).
Key inclusion criteria (19 listed)
- ≥ 18-year-old
- English speaking (per Sutter medical records information)
- Ability and willingness to provide signed Consent Form
- Ability to comply with the study protocol
- Ability to attend the study visit, complete questionnaires, have blood collected and tested And, either Long-COVID or Healthy control as described below
Key exclusion criteria (43 listed)
- Pregnant or nursing woman
- Alcohol or another drug abuse ongoing within one year
- Severe depression or acute suicidal ideation
- Bipolar disorder, schizophrenia, or other psychosis
- History of malignancy, except basal cell carcinoma
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
Metagenomics
Time frame: Baseline
In this proof-of-concept study, we want to test the hypothesis that mcfDNA has diagnostic utility as a biomarker for long COVID patients by applying the agnostic metagenomic sequencing approach.
Cytokines
Time frame: Baseline
Cytokine signatures have been associated with disease severity in patients with chronic fatigue syndrome (Montoya et al, Proc Natl Acad Sci U S A. 2017 Aug 22;114(34): E7150-E7158.). We want to test the hypothesis that cytokine profiles may serve as surrogate biomarkers for Long COVID.
Metadata analysis
Time frame: Baseline
Analysis of microbial-cell-free DNA and cytokine to identity meta-signatures associated with Long COVID and/or Long COVID severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- 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.
Jose G Montoya principal investigator
Sutter Health, Palo Alto Medical Foundation
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 Post-Acute COVID-19 Syndrome, run by Palo Alto Medical Foundation 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 19 inclusion and 43 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: enrolling by invitation, as of the sponsor's last update on 20 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Metagenomics (time frame: Baseline). The study lists 3 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 20 Jul 2025.