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COVID-19 Longitudinal Biomarkers in Lung Injury (COLOBILI)

9 de fevereiro de 2021 atualizado por: Dr. Andrew Baker

Profile known and novel biomarkers in blood in COVID19 patients to characterize the host response to SARS-CoV-2 over time and in response to treatment.

The investigators aim to:

  • Better understand the disease. The investigators will achieve this by characterizing the biology of COVID-19 infection and the pathophysiology of the host response using clinical data together with cellular and molecular measurements over the course of the disease. This will allow better insights for the discovery and development of novel therapeutics.
  • Understand why different patients have different phenotypes and disease presentations over time. The investigators will achieve this by analyzing for patient subgroups. This will allow targeted patient stratification and better matching of resources.
  • Understand how patients are responding to the different medications being tested in clinical trials. The investigators will achieve that by co-enrolling with therapeutic trials. This will allow an understanding of the biological effects of these interventions.

Study Design: Observational adaptive study of a translational nature, combining clinical data and basic science investigations in blood samples in the same patients, longitudinally, with serial interim analyses.

Primary outcomes: 90 day ICU mortality. Secondary outcomes: measures of ICU utilization and disease severity, and 90 day in-hospital mortality.

The study ends after 3 months from admission to the ICU, hospital discharge or death.

Location: St. Michael's Hospital (Unity Health Toronto), an academic center in downtown Toronto affiliated with the University of Toronto.

The investigators will collect: A) Detailed clinical data including investigations, mechanical ventilation and cardiovascular parameters. B) Blood samples for state-of-the-art multi-omics biomarker discovery and development: cytokines, anti-COVID19 antibodies, autoimmune serology, metabolomics, transcriptomics, epigenomics, deep immune phenotyping, viral loads. For those patients who die with COVID19 The investigators will perform bedside post-mortem biopsies of lung, heart, kidney and muscle.

Sampling times: From admission to the maximal severity phase through convalescence, in order to capture the evolution and dynamics of the disease and the recovery process: days 0,1, 3, 5, 7, 10, 15 and 22, and then every 2 weeks until the end of the study (3 months from admission to the ICU, hospital discharge or death).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Antecipado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Canadá
    • Ontario
      • Toronto, Ontario, Canadá, M5B 1W8

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients admitted to the critical care unit or general medicine ward in a tertiary referral medical center.

Descrição

  • Primary Cohort: Patients admitted to the ICU with respiratory deterioration suspected or confirmed to be due to SARS-CoV-2. Suspicion will be based on the clinical criteria in place at SMH, with the threshold for inclusion being a suspicion high enough to use PPE until confirmatory testing results are obtained. Only patients found to be COVID19 positive will stay in this cohort. This population will be called "ICU Positive".
  • Secondary Cohort: Patients admitted to the ICU for any reason who are COVID19 positive, regardless of admission date or when they are found to be COVID19 positive. This population will be called "ICU Positive - delayed"
  • Biological controls in the ICU: Any patients from the primary cohort who are found to be COVID19 negative. This population will be called "ICU negative".
  • Biological controls outside the ICU: Patients admitted to the floor with respiratory deterioration suspected or confirmed to be due to SARS-CoV-2, or that develop such respiratory deterioration within 15 days of admission (i.e. become "persons under investigation"). Suspicion will be based on the clinical criteria in place at SMH, with the threshold for inclusion being a suspicion high enough to use PPE until confirmatory testing results are obtained. Only patients found to be COVID19 positive will stay in this cohort. If these patients require ICU admission within 15 days, they will cross-over to the "ICU positive" cohort and count towards that cohort (i.e. number of recruited patients). If they don't require ICU admission within 15 days, they will stay in this cohort and be called "never ICU".
  • Healthy volunteers: The investigators will recruit healthy volunteers among healthcare workers and allied personnel in the hospital. They will provide peripheral blood to serve as: a) independent controls for experimental and laboratory variables, and b) references of healthy baseline state for experiments.
  • A patient previously enrolled as a COVID negative can be re-enrolled in a subsequent hospitalization with a new study ID (i.e. counts as another encounter for the total enrollment). The records will be linked to indicate they represent the same person enrolled again.

Exclusion Criteria

  • Refusal to participate.
  • Inability to record the primary outcome during the first 2 weeks.
  • For the ICU positive and ICU negative cohorts only: failure to obtain the day 0 or 1 blood sample (for example technical problems, or identification of COVID-19 after ICU admission i.e. there was no suspicion on admission).
  • For the ward patients, inability to collect day 1 or 2 blood sample.
  • Known to have had COVID in the past (>4 weeks) in any setting.
  • Healthy volunteers only: COVID19 known or suspected infection, or unprotected exposure to a known acutely ill COVID19 patient in the past 4 weeks; and/or currently unwell or in the course of an acute illness.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: Coorte
  • Perspectivas de Tempo: Prospectivo

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
COVID positive
Patients admitted to the ICU with respiratory distress found to be COVID19 positive.
Outro: no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
COVID negative
Patients admitted to the ICU with respiratory distress found to be COVID19 negative
Outro: no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
COVID positive delayed
Patients admitted to the ICU for an indication other than respiratory distress, found to be COVID19 positive.
Outro: no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
never-ICU
Patients admitted to the internal medicine ward with respiratory distress found to be COVID19 positive.
Outro: no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
no interventions performed. Just collecting data, blood samples and post-mortem biopsies.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Death in ICU
Prazo: within 3 months from admission
Death in ICU
within 3 months from admission

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Days in ICU
Prazo: within 3 months from admission to the ICU
Length of hospitalization
within 3 months from admission to the ICU
Mechanical ventilation days
Prazo: within 3 months from admission to the ICU
Length of mechanical ventilation while in the ICU
within 3 months from admission to the ICU
Days of mechanical ventilation rescue measures
Prazo: within 3 months from admission to the ICU
Number of days on which the patient was treated with one or more of the following rescue meaures: neuromuscular blockade, inhaled NO, proning.
within 3 months from admission to the ICU
APACHE II score on admission
Prazo: On admission to the ICU
Acute Physiology And Chronic Health Evaluation II. Min 0, Max 71. Higher scores impart higher mortality risk.
On admission to the ICU
SOFA score
Prazo: On the same days as blood sampling: days 0,1, 3, 5, 7, 10, 15 and 22, and then every 2 weeks until the end of the study (3 months from admission to the ICU, hospital discharge or death).
Sequential Organ Failure Assessment, calculated daily. Min 6, Max 24. Higher scores impart higher mortality risk.
On the same days as blood sampling: days 0,1, 3, 5, 7, 10, 15 and 22, and then every 2 weeks until the end of the study (3 months from admission to the ICU, hospital discharge or death).
In hospital death
Prazo: within 3 months from admission
In hospital death
within 3 months from admission

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Dr. Andrew Baker

Investigadores

  • Investigador principal: Andrew J Baker, MD, Unity Health Toronto

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de março de 2020

Conclusão Primária (Antecipado)

1 de outubro de 2021

Conclusão do estudo (Antecipado)

31 de dezembro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

3 de fevereiro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de fevereiro de 2021

Primeira postagem (Real)

10 de fevereiro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de fevereiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de fevereiro de 2021

Última verificação

1 de fevereiro de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • COLOBILI v4.2

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Indeciso

Descrição do plano IPD

Depends on the type of data requested

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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