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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: VIPER Study UCSF
- Número de telefone: (415) 502-2449
- E-mail: VIPERStudy@ucsf.edu
Estude backup de contato
- Nome: Lynn Ngo, MPH
- Número de telefone: (415) 322-8432
- E-mail: Lynn.Ngo@ucsf.edu
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94110
- Recrutamento
- Zuckerberg San Francisco General Hospital
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Contato:
- Lynn Ngo, MPH
- Número de telefone: (415) 322-8432
- E-mail: Lynn.Ngo@ucsf.edu
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Investigador principal:
- Michael Peluso
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Long COVID
People experiencing Long COVID symptoms
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Recovered
People who have fully recovered from their COVID infection(s)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sexo do participante
Prazo: Visita inicial
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A proporção de homens e mulheres que participaram da visita inicial.
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Visita inicial
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Participant age
Prazo: Baseline visit
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The median age of study participants at enrollment
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Baseline visit
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Participant race/ethnicity
Prazo: Baseline visit
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The proportion of participants from each demographic group
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Baseline visit
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Proportion of participants previously hospitalized
Prazo: Baseline visit
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The proportion of participants who were previously hospitalized
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Baseline visit
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Colonoscopy Completed
Prazo: Baseline visit
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The proportion of participants completing a research colonoscopy for the study
|
Baseline visit
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Protocol complete
Prazo: Up to 6 weeks from baseline
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The proportion of enrolled participants who complete all study activities
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Up to 6 weeks from baseline
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Long COVID Symptom Assessment
Prazo: Screening, baseline, and up to 6 weeks
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Participant-reported assessment for presence and severity of persistent post-COVID-19 symptoms
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Screening, baseline, and up to 6 weeks
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Qualify of Life Assessment (Global Health Score)
Prazo: Screening, baseline, and up to 6 weeks
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Measure of overall health-related quality of life
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Screening, baseline, and up to 6 weeks
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Mental Health Symptom Assessment
Prazo: Screening visit
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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.
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Screening visit
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Cognitive Symptom Assessment
Prazo: Screening visit
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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.
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Screening visit
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Fatigue Symptom Assessment
Prazo: Baseline and up to 6 weeks
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An instrument such as the FACIT-Fatigue will be used to assess fatigue severity and its impact on daily activities.
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Baseline and up to 6 weeks
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Gastrointestinal Symptom Assessment
Prazo: Baseline and up to 6 weeks
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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.
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Baseline and up to 6 weeks
|
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Neurocognitive Function Assessment
Prazo: Baseline and up to 6 weeks
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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.
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Baseline and up to 6 weeks
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Physical Function Symptom Assessment
Prazo: Baseline and up to 6 weeks
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An instrument such as the PROMIS Physical Function will be used to assess participants' ability to perform physical activities of daily living.
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Baseline and up to 6 weeks
|
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Autonomic Symptom Assessment
Prazo: Baseline and up to 6 weeks
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A questionnaire such as the COMPASS-31 or Orthostatic Hypotension Questionnaire (OHQ) will be used to assess autonomic nervous system symptoms across symptom domains.
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Baseline and up to 6 weeks
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Post-Exertional Malaise Symptom Assessment
Prazo: Baseline and up to 6 weeks
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An instrument such as the DSQ-PEM will be used to assess the severity of post-exertional malaise
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Baseline and up to 6 weeks
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Grip Strength Test
Prazo: Up to 6 weeks from baseline
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Objective measure of hand grip strength using a hand dynamometer
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Up to 6 weeks from baseline
|
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30-Second Sit-to-Stand Test
Prazo: Up to 6 weeks from baseline
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Objective performance test measuring the number of full stands from a seated position completed in 30 seconds
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Up to 6 weeks from baseline
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Active Standing Test
Prazo: Up to 6 weeks from baseline
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Objective measurement of changes in heart rate and blood pressure upon transition from lying/sitting to standing
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Up to 6 weeks from baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios pós-infecciosos
- COVID-19
- Processos Patológicos
- Doença crônica
- Atributos da doença
- Infecções do Trato Respiratório
- Infecções
- Infecções por vírus de RNA
- Doenças Virais
- Doenças Respiratórias
- Doenças pulmonares
- Pneumonia Viral
- Pneumonia
- Infecções por coronavírus
- Infecções por Coronaviridae
- Infecções por Nidovírus
- Condições Patológicas, Sinais e Sintomas
- Síndrome Pós-Aguda de COVID-19
Outros números de identificação do estudo
- 25-45159
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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