ClinicalTrials.gg
RecruitingNCT07770022VIPERUpdated Aug 18, 2026

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

An observational study in Long Covid, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by University of California, San Francisco · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 194 studies in Post-Acute COVID-19 Syndrome with a site in United States — 63 open to participants now, 84 under way, 7 of them phase 3. Post-Acute COVID-19 Syndrome · United States.

Planned enrollment
20th of 37
150 · median 155
Started
2026
with 11 others
Observational
37 of 194
16 open now
Primary completion
2031-05
later than 83 of 83 live
Registered
192nd of 194
by date

Among the 194 studies in Post-Acute COVID-19 Syndrome with a site in United States, this one is the 20th largest by planned enrollment of the 37 observational ones that give a count, is one of 12 that started in 2026, is one of 37 observational ones, reaches primary completion later than 83 of the 83 other live ones, and was the 192nd registered.

Post-Acute COVID-19 Syndrome

604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.

Browse Post-Acute COVID-19 Syndrome studies →

Open to participants now

63 of the 194 studies in Post-Acute COVID-19 Syndrome with a site in United States are open now. Recruiting first, the newest first:

57 more — sign in →

All 63 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 146 Post-Acute COVID-19 Syndrome studies recruiting now, 70 (48%) set no upper age limit and 53 (36%) stop at 75 or younger; 15 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 194 studies in Post-Acute COVID-19 Syndrome with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed description

The lack of a biomarker for Long COVID (LC) is the single biggest obstacle to the development of a cure for this disabling infection-associated chronic condition (IACC). Development of biomarkers to date has been sluggish and uncoordinated, in part due to the lack of resources invested in this effort and in part due to the lack of a central biospecimen collection, distribution, and analytic resource to support the work of laboratories who are developing compelling assays for this condition using novel technologies. Currently, the work of assay development is highly siloed - individual laboratories working with relatively small numbers of samples from participants from individual cohorts with a variable degree of clinical phenotyping are developing individual assays that have not been robustly validated or compared head-to-head with similar assays. The result has been a lack of progress in advancing Long COVID diagnostics, which in turn has limited the development of Long COVID treatments and ultimately a cure.

The UCSF Viral Immunology and Persistence Repeat Donor Cohort (VIPER) program aims to address these challenges by serving as a central, gold-standard resource to support the development of biomarkers for Long COVID. Developed within the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC) research program (UCSF IRB # 20-30479) - one of the most highly visible and productive Long COVID studies in the world - VIPER will enroll and deeply phenotype individuals with well-defined Long COVID as well as those who have fully recovered from SARS-CoV-2 infection. All participants will undergo a combination of non-invasive (blood, saliva, stool) and invasive (tissue biopsy) sampling using established procedures, with collection of ample amounts of biological specimens to support downstream biomarker development. VIPER specimens will be centrally housed and distributed to collaborating laboratories, who while blinded to the characteristics of the participants will generate measurements that are shared with a central data core for analysis. This will enable the determination of how each assay performs relative to both clinical and laboratory "gold standards" and how each assay performs relative to each other.

Following the identification and validation of these biomarkers, this program will also determine how these tests can be used to assess eligibility and outcomes in LC trials. Ultimately, the goal of VIPER is to promote the development of biomarker tests that can be utilized in the clinic setting to identify those who are likely to benefit from therapeutics targeting each of the mechanisms of Long COVID.

03

Conditions studied

  • Long Covid

Keywords

  • Long COVID
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willing and able to provide written , 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 procedure under related IRB-approved protocols.

Exclusion criteria

Exclusion Criteria:

  • Self-reported or documented chronic anemia with \< 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.
  • 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 .
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Long COVID

    People experiencing Long COVID symptoms

  • Recovered

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

06

What researchers measure

Primary outcomes

  1. Participant age

    The median age of study participants at enrollment

    Time frame: Baseline visit

  2. Participant sex

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

    Time frame: Baseline visit

  3. Participant race/ethnicity

    The proportion of participants from each demographic group

    Time frame: Baseline visit

  4. Proportion of participants previously hospitalized

    The proportion of participants who were previously hospitalized

    Time frame: Baseline visit

  5. Colonoscopy Completed

    The proportion of participants completing a research colonoscopy for the study

    Time frame: Baseline visit

Secondary outcomes

  1. Protocol complete

    The proportion of enrolled participants who complete all study activities

    Time frame: Up to 6 weeks from baseline

Other outcomes

  1. Long COVID Symptom Assessment

    Participant-reported assessment for presence and severity of persistent post-COVID-19 symptoms

    Time frame: Screening, baseline, and up to 6 weeks

  2. Qualify of Life Assessment (Global Health Score)

    Measure of overall health-related quality of life

    Time frame: Screening, baseline, and up to 6 weeks

  3. Mental Health Symptom Assessment

    An instrument such as the PHQ-9 will be used to assess participants' overall mental health status. These will include questions about anxiety and depression, independent of Long COVID association.

    Time frame: Screening visit

  4. Cognitive Symptom Assessment

    An instrument such as the Everyday Cognition survey will be used to asses perceived changes in everyday cognitive function across domains compared to participants' pre-COVID baselines.

    Time frame: Screening visit

  5. Fatigue Symptom Assessment

    An instrument such as the FACIT-Fatigue will be used to assess fatigue severity and its impact on daily activities.

    Time frame: Baseline and up to 6 weeks

  6. Gastrointestinal Symptom Assessment

    An instrument such as the Modified Gastrointestinal Symptom Rating Scale (GSRS) will be used to assess the severity of gastrointestinal symptoms across multiple symptom domains.

    Time frame: Baseline and up to 6 weeks

  7. Neurocognitive Function Assessment

    A computer-based neurocognitive test such as CNS Vital Signs will be used to assess cognitive function across multiple domains including memory, attention, psychomotor speed, and executive function.

    Time frame: Baseline and up to 6 weeks

  8. Physical Function Symptom Assessment

    An instrument such as the PROMIS Physical Function will be used to assess participants' ability to perform physical activities of daily living.

    Time frame: Baseline and up to 6 weeks

  9. Autonomic Symptom Assessment

    A questionnaire such as the COMPASS-31 or Orthostatic Hypotension Questionnaire (OHQ) will be used to assess autonomic nervous system symptoms across symptom domains.

    Time frame: Baseline and up to 6 weeks

  10. Post-Exertional Malaise Symptom Assessment

    An instrument such as the DSQ-PEM will be used to assess the severity of post-exertional malaise

    Time frame: Baseline and up to 6 weeks

  11. Grip Strength Test

    Objective measure of hand grip strength using a hand dynamometer

    Time frame: Up to 6 weeks from baseline

  12. 30-Second Sit-to-Stand Test

    Objective performance test measuring the number of full stands from a seated position completed in 30 seconds

    Time frame: Up to 6 weeks from baseline

  13. Active Standing Test

    Objective measurement of changes in heart rate and blood pressure upon transition from lying/sitting to standing

    Time frame: Up to 6 weeks from baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for May 2031, 59 months after the start.

Of 98 non-industry observational studies under Post-Acute COVID-19 Syndrome, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 59 months is above that.

Counting every sponsor, half of 105 studies reached it within 27 months; a quarter within 14 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2026
First posted
Aug 18, 2026
StartActual
May 18, 2026
Primary completionEst.
May 15, 2031
CompletionEst.
May 15, 2031
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07770022
Collaborators
PolyBio Research Foundation
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
May 18, 2026
Primary completion
May 15, 2031 (estimated)
Completion
May 15, 2031 (estimated)
Last update
Aug 18, 2026

Study contacts

VIPER Study UCSF
Contact
VIPERStudy@ucsf.edu
(415) 502-2449
Lynn Ngo, MPH
Contact
Lynn.Ngo@ucsf.edu
(415) 322-8432

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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