Covid19COLOBILINCT04747782
COVID-19 Longitudinal Biomarkers in Lung Injury
An observational study of Covid19 and Respiratory Disease, run by Dr. Andrew Baker at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Respiratory Disease, Critical Illness
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 23 Mar 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to the critical care unit or general medicine ward in a tertiary referral medical center.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Marlene Santos, 416-360-4000 ext. 2322, Marlene.Santos@unityhealth.to
Victoria Paz, 416-864-5559, Victoria.Paz@unityhealth.to
About this study
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:
Read more
- 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).
- Conditions
- Covid19, Respiratory Disease, Critical Illness
- Being tested
- no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
- Medical subject headings
- COVID-19, Respiration Disorders, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID positive | Patients admitted to the ICU with respiratory distress found to be COVID19 positive. Receives: Other: 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 Receives: Other: 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. Receives: Other: 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. Receives: Other: no interventions performed. Just collecting data, blood samples and post-mortem biopsies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death in ICU
Death in ICU
Measured: within 3 months from admission
Secondary outcomes (6)
Days in ICU
Length of hospitalization
Measured: within 3 months from admission to the ICU
Mechanical ventilation days
Length of mechanical ventilation while in the ICU
Measured: 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.
Measured: 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.
Measured: On admission to the ICU
SOFA score
Sequential Organ Failure Assessment, calculated daily. Min 6, Max 24. Higher scores impart higher mortality risk.
Measured: 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
Measured: within 3 months from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start23 Mar 2020
- Primary completion1 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Andrew Baker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Andrew Baker, Unity Health Toronto
- Investigators
- Andrew J Baker, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747782
- Sponsor's protocol ID
- COLOBILI v4.2
- Acronym
- COLOBILI
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on the type of data requested
Publications
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.
PubMed 33928414Trahtemberg 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.
PubMed 33903092
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Longitudinal Biomarkers in Lung Injury
- ClinicalTrials.gov ID
- NCT04747782
- Acronym / sponsor ID
- COLOBILI / COLOBILI v4.2
- Conditions
- Covid19, Respiratory Disease, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Andrew BakerUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID positive | – | Other: 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 negative | – | Other: 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 |
| COVID positive delayed | – | Other: 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. |
| never-ICU | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the critical care unit or general medicine ward in a tertiary referral medical center.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventions performed. Just collecting data, blood samples and post-mortem biopsies.no interventions performed. Just collecting data, blood samples and post-mortem biopsies. | Other | COVID negative, COVID positive, COVID positive delayed, never-ICU |
Primary outcome
Death in ICU
Time frame: within 3 months from admission
Death in ICU
6 secondary outcomes
Days in ICU
Time frame: within 3 months from admission to the ICU
Mechanical ventilation days
Time frame: within 3 months from admission to the ICU
Days of mechanical ventilation rescue measures
Time frame: within 3 months from admission to the ICU
APACHE II score on admission
Time frame: On admission to the ICU
SOFA score
Time frame: 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
Time frame: within 3 months from admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 33928414Trahtemberg 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.
- Derived from this study: PubMed 33903092Trahtemberg 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.
- Individual participant dataSharing planned: Undecided. Depends on the type of data requested
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Baker, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Respiratory Disease, run by Dr. Andrew Baker at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlene Santos (416-360-4000 ext. 2322, Marlene.Santos@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death in ICU (time frame: within 3 months from admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747782, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.