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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID positive | Patients admitted to the ICU with respiratory distress found to be COVID19 positive. |
| |
| COVID negative | Patients admitted to the ICU with respiratory distress found to be COVID19 negative |
| |
| COVID positive delayed | Patients admitted to the ICU for an indication other than respiratory distress, found to be COVID19 positive. |
| |
| never-ICU | Patients admitted to the internal medicine ward with respiratory distress found to be COVID19 positive. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no interventions performed. Just collecting data, blood samples and post-mortem biopsies. | Other | no interventions performed. Just collecting data, blood samples and post-mortem biopsies. |
| Measure | Description | Time Frame |
|---|---|---|
| Death in ICU | Death in ICU | within 3 months from admission |
| Measure | Description | Time Frame |
|---|---|---|
| Days in ICU | Length of hospitalization | within 3 months from admission to the ICU |
| Mechanical ventilation days | Length of mechanical ventilation while in the ICU |
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Exclusion Criteria
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Patients admitted to the critical care unit or general medicine ward in a tertiary referral medical center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlene Santos | Contact | 416-360-4000 | 2322 | Marlene.Santos@unityhealth.to |
| Victoria Paz | Contact | 416-864-5559 | Victoria.Paz@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| Andrew J Baker, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33928414 | Derived | Trahtemberg U, Fritzler MJ; On behalf of the COVID-19 chapter of the "Longitudinal Biomarkers in Lung Injury" study group. COVID-19-associated autoimmunity as a feature of acute respiratory failure. Intensive Care Med. 2021 Jul;47(7):801-804. doi: 10.1007/s00134-021-06408-z. Epub 2021 Apr 30. No abstract available. | |
| 33903092 | Derived |
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Depends on the type of data requested
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012120 | Respiration Disorders |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| within 3 months from admission to the ICU |
| Days of mechanical ventilation rescue measures | 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 | Acute Physiology And Chronic Health Evaluation II. Min 0, Max 71. Higher scores impart higher mortality risk. | On admission to the ICU |
| SOFA score | 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 | In hospital death | within 3 months from admission |
| Trahtemberg U, Rottapel R, Dos Santos CC, Slutsky AS, Baker A, Fritzler MJ. Anticardiolipin and other antiphospholipid antibodies in critically ill COVID-19 positive and negative patients. Ann Rheum Dis. 2021 Sep;80(9):1236-1240. doi: 10.1136/annrheumdis-2021-220206. Epub 2021 Apr 26. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |