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COVID-19 Longitudinal Biomarkers in Lung Injury (COLOBILI)

9 febbraio 2021 aggiornato da: 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).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Anticipato)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
COVID positive
Patients admitted to the ICU with respiratory distress found to be COVID19 positive.
Altro: 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
Altro: 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.
Altro: 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.
Altro: no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
no interventions performed. Just collecting data, blood samples and post-mortem biopsies.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Death in ICU
Lasso di tempo: within 3 months from admission
Death in ICU
within 3 months from admission

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Days in ICU
Lasso di tempo: within 3 months from admission to the ICU
Length of hospitalization
within 3 months from admission to the ICU
Mechanical ventilation days
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: within 3 months from admission
In hospital death
within 3 months from admission

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dr. Andrew Baker

Investigatori

  • Investigatore principale: Andrew J Baker, MD, Unity Health Toronto

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 marzo 2020

Completamento primario (Anticipato)

1 ottobre 2021

Completamento dello studio (Anticipato)

31 dicembre 2021

Date di iscrizione allo studio

Primo inviato

3 febbraio 2021

Primo inviato che soddisfa i criteri di controllo qualità

9 febbraio 2021

Primo Inserito (Effettivo)

10 febbraio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 febbraio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 febbraio 2021

Ultimo verificato

1 febbraio 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • COLOBILI v4.2

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Descrizione del piano IPD

Depends on the type of data requested

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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