COVID-19 Longitudinal Biomarkers in Lung Injury
- Conditions
- Covid19Respiratory DiseaseCritical Illness
- Interventions
- Other: no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
- Registration Number
- NCT04747782
- Lead Sponsor
- Dr. Andrew Baker
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID positive no interventions performed. Just collecting data, blood samples and post-mortem biopsies. Patients admitted to the ICU with respiratory distress found to be COVID19 positive. COVID positive delayed no interventions performed. Just collecting data, blood samples and post-mortem biopsies. Patients admitted to the ICU for an indication other than respiratory distress, found to be COVID19 positive. COVID negative no interventions performed. Just collecting data, blood samples and post-mortem biopsies. Patients admitted to the ICU with respiratory distress found to be COVID19 negative never-ICU no interventions performed. Just collecting data, blood samples and post-mortem biopsies. Patients admitted to the internal medicine ward with respiratory distress found to be COVID19 positive.
- Primary Outcome Measures
Name Time Method Death in ICU within 3 months from admission Death in ICU
- Secondary Outcome Measures
Name Time Method Days of mechanical ventilation rescue measures 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.
Days in ICU within 3 months from admission to the ICU Length of hospitalization
Mechanical ventilation days within 3 months from admission to the ICU Length of mechanical ventilation while in the ICU
In hospital death within 3 months from admission In hospital death
APACHE II score on admission On admission to the ICU Acute Physiology And Chronic Health Evaluation II. Min 0, Max 71. Higher scores impart higher mortality risk.
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). Sequential Organ Failure Assessment, calculated daily. Min 6, Max 24. Higher scores impart higher mortality risk.
Trial Locations
- Locations (1)
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada