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Clinical Trials/NCT04747782
NCT04747782
Unknown
Not Applicable

COVID-19 Longitudinal Biomarkers in Lung Injury

Dr. Andrew Baker1 site in 1 country200 target enrollmentMarch 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Dr. Andrew Baker
Enrollment
200
Locations
1
Primary Endpoint
Death in ICU
Last Updated
5 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
March 23, 2020
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr. Andrew Baker
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Andrew Baker

Chief, Departments of Critical Care and Anesthesia, St Michael's Hospital

Unity Health Toronto

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Death in ICU

Time Frame: within 3 months from admission

Death in ICU

Secondary Outcomes

  • Days of mechanical ventilation rescue measures(within 3 months from admission to the ICU)
  • Days in ICU(within 3 months from admission to the ICU)
  • Mechanical ventilation days(within 3 months from admission to the ICU)
  • In hospital death(within 3 months from admission)
  • APACHE II score on admission(On admission to the ICU)
  • SOFA score(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).)

Study Sites (1)

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