Microbial and Cytokine Signatures in Long COVID Patients

NCT07074158 | Enrolling By Invitation

• 1 other identifier: 2024.133EXP
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

Long COVID

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Baseline

• Metadata analysis

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

  Baseline

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• ≥ 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:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Medical Foundation: lead

Study Sites (1)

Sutter Health Palo Alto Center

Palo Alto, California, 94301, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will also be stored for future comparative studies of additional immune profiles.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose G Montoya

  Sutter Health, Palo Alto Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)