Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-04 @ 6:54 PM
Study NCT ID:
NCT07074158
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-20
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbial and Cytokine Signatures in Long COVID Patients
Sponsor:
Palo Alto Medical Foundation
Organization:
Study Overview
Official Title:
Identification of Microbial and Cytokine Signatures in Long COVID Patients: A Case-control Study of Long COVID Patients With Healthy Individuals
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Two measures will be obtained from participants' plasma:
1. microbial signatures using Karius' agnostic metagenomic assay via microbial cell-free DNA (mcfDNA) sequencing (kariusdx.com)
2. 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.
1. microbial signatures using Karius' agnostic metagenomic assay via microbial cell-free DNA (mcfDNA) sequencing (kariusdx.com)
2. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: