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NCT07074158

Microbial and Cytokine Signatures in Long COVID Patients

Enrolling by Invitation
Not specifiedAges 18+Observational
Palo Alto Medical Foundation
~150 participants
Updated 2025-07-20 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Metagenomics
Measured over Baseline
+2 more outcomes measured

Conditions

Post-Acute COVID-19 Syndrome

Explore related trials

Post-Acute Sequelae of COVID-19

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jose G Montoya · PRINCIPAL_INVESTIGATOR · Sutter Health, Palo Alto Medical Foundation

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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)
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:
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).

Exclusion

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:
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

What this trial measures

  • MetagenomicsBaseline

    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.

  • CytokinesBaseline

    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 analysisBaseline

    Analysis of microbial-cell-free DNA and cytokine to identity meta-signatures associated with Long COVID and/or Long COVID severity.