Validation of Biomarkers for Long COVID in the LIINC Viral Immunopathogenesis and Persistence Repeat Donor Cohort (VIPER) (VIPER)
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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: VIPER Study UCSF
- Telefonszám: (415) 502-2449
- E-mail: VIPERStudy@ucsf.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Lynn Ngo, MPH
- Telefonszám: (415) 322-8432
- E-mail: Lynn.Ngo@ucsf.edu
Tanulmányi helyek
-
-
California
-
San Francisco, California, Egyesült Államok, 94110
- Toborzás
- Zuckerberg San Francisco General Hospital
-
Kapcsolatba lépni:
- Lynn Ngo, MPH
- Telefonszám: (415) 322-8432
- E-mail: Lynn.Ngo@ucsf.edu
-
Kutatásvezető:
- Michael Peluso
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Self-reported or documented chronic anemia with hemoglobin < 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 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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
|---|
|
Long COVID
People experiencing Long COVID symptoms
|
|
Recovered
People who have fully recovered from their COVID infection(s)
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Résztvevő szex
Időkeret: Kiindulási látogatás
|
Az alaplátogatáson részt vevő férfiak és nők aránya.
|
Kiindulási látogatás
|
|
Participant age
Időkeret: Baseline visit
|
The median age of study participants at enrollment
|
Baseline visit
|
|
Participant race/ethnicity
Időkeret: Baseline visit
|
The proportion of participants from each demographic group
|
Baseline visit
|
|
Proportion of participants previously hospitalized
Időkeret: Baseline visit
|
The proportion of participants who were previously hospitalized
|
Baseline visit
|
|
Colonoscopy Completed
Időkeret: Baseline visit
|
The proportion of participants completing a research colonoscopy for the study
|
Baseline visit
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Protocol complete
Időkeret: Up to 6 weeks from baseline
|
The proportion of enrolled participants who complete all study activities
|
Up to 6 weeks from baseline
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Long COVID Symptom Assessment
Időkeret: Screening, baseline, and up to 6 weeks
|
Participant-reported assessment for presence and severity of persistent post-COVID-19 symptoms
|
Screening, baseline, and up to 6 weeks
|
|
Qualify of Life Assessment (Global Health Score)
Időkeret: Screening, baseline, and up to 6 weeks
|
Measure of overall health-related quality of life
|
Screening, baseline, and up to 6 weeks
|
|
Mental Health Symptom Assessment
Időkeret: Screening visit
|
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.
|
Screening visit
|
|
Cognitive Symptom Assessment
Időkeret: Screening visit
|
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.
|
Screening visit
|
|
Fatigue Symptom Assessment
Időkeret: Baseline and up to 6 weeks
|
An instrument such as the FACIT-Fatigue will be used to assess fatigue severity and its impact on daily activities.
|
Baseline and up to 6 weeks
|
|
Gastrointestinal Symptom Assessment
Időkeret: Baseline and up to 6 weeks
|
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.
|
Baseline and up to 6 weeks
|
|
Neurocognitive Function Assessment
Időkeret: Baseline and up to 6 weeks
|
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.
|
Baseline and up to 6 weeks
|
|
Physical Function Symptom Assessment
Időkeret: Baseline and up to 6 weeks
|
An instrument such as the PROMIS Physical Function will be used to assess participants' ability to perform physical activities of daily living.
|
Baseline and up to 6 weeks
|
|
Autonomic Symptom Assessment
Időkeret: Baseline and up to 6 weeks
|
A questionnaire such as the COMPASS-31 or Orthostatic Hypotension Questionnaire (OHQ) will be used to assess autonomic nervous system symptoms across symptom domains.
|
Baseline and up to 6 weeks
|
|
Post-Exertional Malaise Symptom Assessment
Időkeret: Baseline and up to 6 weeks
|
An instrument such as the DSQ-PEM will be used to assess the severity of post-exertional malaise
|
Baseline and up to 6 weeks
|
|
Grip Strength Test
Időkeret: Up to 6 weeks from baseline
|
Objective measure of hand grip strength using a hand dynamometer
|
Up to 6 weeks from baseline
|
|
30-Second Sit-to-Stand Test
Időkeret: Up to 6 weeks from baseline
|
Objective performance test measuring the number of full stands from a seated position completed in 30 seconds
|
Up to 6 weeks from baseline
|
|
Active Standing Test
Időkeret: Up to 6 weeks from baseline
|
Objective measurement of changes in heart rate and blood pressure upon transition from lying/sitting to standing
|
Up to 6 weeks from baseline
|
Együttműködők és nyomozók
Együttműködők
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Fertőzés utáni betegségek
- COVID-19
- Patológiás folyamatok
- Krónikus betegség
- Betegség tulajdonságai
- Légúti fertőzések
- Fertőzések
- RNS vírusfertőzések
- Vírusos betegségek
- Légúti betegségek
- Tüdőbetegségek
- Tüdőgyulladás, vírusos
- Tüdőgyulladás
- Koronavírus fertőzések
- Coronaviridae fertőzések
- Nidovirales fertőzések
- Kóros állapotok, jelek és tünetek
- Akut COVID-19 utáni szindróma
Egyéb vizsgálati azonosító számok
- 25-45159
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .