Validation of Biomarkers for Long COVID in the LIINC Viral Immunopathogenesis and Persistence Repeat Donor Cohort (VIPER)

NCT07770022 | Recruiting

• 1 other identifier: 25-45159
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand the biological changes associated with Long COVID and to identify laboratory tests (biomarkers) that may help diagnose the condition and measure how it changes over time. Researchers will enroll people with Long COVID as well as people who have fully recovered after COVID-19 infection. Participants will provide health information and biological samples, such as blood, saliva, stool, and, for some participants, tissue biopsies. These samples will be used to study the biological processes involved in Long COVID and to support the development of new diagnostic tests that may improve future research, clinical trials, and patient care.

Conditions

Long Covid

Keywords

Long COVID

Outcome Measures

Primary Outcomes (5)

• Participant age

  The median age of study participants at enrollment

  Baseline visit

• Participant sex

  The proportion of men and women participating in the baseline visit.

  Baseline visit

• Participant race/ethnicity

  The proportion of participants from each demographic group

  Baseline visit

• Proportion of participants previously hospitalized

  The proportion of participants who were previously hospitalized

  Baseline visit

• Colonoscopy Completed

  The proportion of participants completing a research colonoscopy for the study

  Baseline visit

Secondary Outcomes (1)

• Protocol complete

  Up to 6 weeks from baseline

Other Outcomes (13)

• Long COVID Symptom Assessment

  Screening, baseline, and up to 6 weeks

• Qualify of Life Assessment (Global Health Score)

  Screening, baseline, and up to 6 weeks

• Mental Health Symptom Assessment

  Screening visit

Study Arms (2)

Long COVID

People experiencing Long COVID symptoms

Recovered

People who have fully recovered from their COVID infection(s)

Eligibility Criteria

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

Study Population

The study population will include adults with well-characterized Long COVID and adults who have recovered following SARS-CoV-2 infection. Participants will be enrolled from the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC) research program and through community outreach and referral efforts. The study aims to include individuals with a range of Long COVID symptom patterns and durations to support research on the biological mechanisms of the condition.

You may qualify if:

• Willing and able to provide written informed consent, and
• Age \>/= 18 years, and
• Either:
• History of a SARS-CoV-2 infection resulting in Long COVID symptoms, confirmed by the investigator, or
• Exposure to SARS-CoV-2 without establishment of Long COVID.
• Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC).
• Enrolled or willing to be referred for a gut biopsy procedure under related IRB-approved protocols.

You may not qualify if:

• Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Sponsors & Collaborators

• University of California, San Francisco: lead
• PolyBio Research Foundation: collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples collected during the study may include blood, saliva, stool, and tissue biopsy specimens. Blood-derived specimens may include whole blood, plasma, serum, peripheral blood mononuclear cells (PBMCs), DNA, RNA, and other derivatives prepared for future laboratory analyses. Samples will be stored in a secure biorepository and may be used for future research related to Long COVID, immune function, viral persistence, and other infection-associated chronic conditions, as described in the informed consent.

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

Central Study Contacts

VIPER Study UCSF

CONTACT

(415) 502-2449; VIPERStudy@ucsf.edu

Lynn Ngo, MPH

CONTACT

(415) 322-8432; Lynn.Ngo@ucsf.edu

Study Design

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

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 18, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): May 15, 2031
• Study Completion (Estimated): May 15, 2031
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

US (1)