The McMaster Multi-Regional COVID-19 Hospital Case Registry (COREG)
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|ClinicalTrials.gov Identifier: NCT04508959|
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : November 24, 2020
|Condition or disease|
|Coronavirus Infection Coronavirus SARS-CoV-2 Infection Covid19|
Rationale: The novel coronavirus disease of 2019 (COVID-19) is a rapidly evolving pandemic, which poses a major and ongoing threat to health and the health system both globally and locally. While there have been country-specific case series that have offered some guidance on interventions that may be effective; applying them to local settings is problematic, given differences in population density, demographics (including vulnerable sub-populations), economic and political capacity. To this end, local data is needed to better inform on the timing and implementation of specific and targeted interventions to mitigate the spread and impact of the virus immediately, and thereafter. Near real-time information can greatly inform efforts and decisions needed to address resource allocation in response to the dynamic pandemic.
Objectives: The Investigators' aim is to collect data on the impact and burden of COVID-19 that can inform and support real-time local clinical and policy decisions. Specifically, the objectives are to: 1) Create a COVID-19 admission case registry as a local research and quality improvement platform for the COVID-19 pandemic; and 2) Collect data that can inform local pandemic decisions and evaluation, including incidence, vulnerability, complications, and clinical course of COVID-19 patients.
Methods: The investigators have established the McMaster Coronavirus (COVID-19) Registry (COREG), an ISARIC-WHO compatible, comprehensive platform that facilitates uniform data collection of COVID-19. COREG is an extension of the ISARIC-WHO case report form (CRF) designed to capture local information on transmission, disease- burden, course, and outcomes of COVID-19 cases from all COVID-19 charting hospitals in the Waterloo, Hamilton, and Niagara Regions of Ontario, Canada (Population > 1,500,000). COREG is a comprehensive patient registry based retrospective data collection on all suspected and confirmed COVID-19 cases (according to the ISARIC definition) admitted to St. Joseph's Healthcare Hamilton (SJHH), Hamilton Health Sciences (HHS), Grand River Hospital, St. Mary's General Hospital, and the Niagara Health System. The registry includes data abstracted from existing chart data generated during routine clinical care. A waiver of informed consent is granted. Data categories to be collected follow the ISARIC-WHO CRF (https://isaric.tghn.org/covid-19-clinical-research-resources/) and include demographics, co-morbidities, pre-admission medications, signs and symptoms, diagnostic results, in-hospital interventions and health outcomes (medical complications during hospitalization including ICU and death). Cases are identified by the Infection Prevention and Control (IPAC) at each site and records will be accessed remotely and securely by research and medical staff. Extracted data are stored in a secure McMaster hosted REDCap and data server. Data collectors undergo a standardized training. Weekly governance meetings occur between the data collectors, operational leads and clinical site lead at each site to discuss, address and resolve any barriers and inconsistences in data collection and advance the scientific agenda.
Impact: COREG ensures that COVID-19 data collected are standardized and robust and will have a meaningful impact on local decision-making, while also being comparable internationally. COREG will shape consensus recommendations on inpatient management of hospitalized patients with COVID-19. It will be invaluable to local and global research efforts, since linkage to tissue biobanks and other administrative databases can be easily performed to address questions on pathophysiology, long-term outcomes and healthcare burden.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1500 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||A Rapid Research Platform to Inform Prevention & Improve the Clinical Management of COVID-19 Illness for Priority Older Adult Groups: The McMaster Multi-regional Hospital Coronavirus Registry|
|Actual Study Start Date :||April 15, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
All individuals screened using the hospital's microbiology laboratory.
Outpatient (Emergency Department) cases
All individuals seen in the emergency department who test positive for COVID-19.
Inpatient (General Medical or Intensive Care) cases
All individuals admitted to a general or intensive care bed who test positive for COVID-19.
- Serious COVID-19 infection [ Time Frame: through study completion, an average of 1 year ]Defined as symptomatic hospital outpatients with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) through the COREG platform.
- Severe infection (requiring admission) [ Time Frame: through study completion, an average of 1 year ]Defined as persons admitted with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform. We will also conduct sub analyses of hospital acquired COVID-19 also captured in the COREG platform.
- COVID-19 related death [ Time Frame: through study completion, an average of 1 year ]Defined as persons who died with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform.
- Length of stay [ Time Frame: through study completion, an average of 1 year ]Days from admission to discharge.
- Complications [ Time Frame: through study completion, an average of 1 year ]New or increased severity of conditions and syndromes from pre-morbid state.
- Intensive interventions [ Time Frame: through study completion, an average of 1 year ]Rate of intensive interventions during hospital stay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508959
|Contact: Andrew P Costa, PhDemail@example.com|
|Contact: Darly Dash, MScfirstname.lastname@example.org|
|Hamilton General Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8L2X2|
|Contact: Mats L Junek, MD, MSc email@example.com|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L9C0E3|
|Contact: Jessica Kapralik, MD (PGY5) firstname.lastname@example.org|
|Grand River Hospital||Recruiting|
|Kitchener, Ontario, Canada, N2G1G3|
|Contact: Tyler Pitre, MA, MD (PGIM) email@example.com|
|St. Mary's General Hospital||Recruiting|
|Kitchener, Ontario, Canada, N2M1B2|
|Contact: Tyler Pitre, MA, MD (PGIM) firstname.lastname@example.org|
|Niagara Health System||Recruiting|
|St. Catharines, Ontario, Canada, L2S0A9|
|Contact: Lisa Patterson email@example.com|
|Principal Investigator:||Rebecca J Kruisselbrink, MD, MPH, FRCPC||McMaster University|
|Principal Investigator:||MyLinh Duong, MBBS, MSc, FRACP||McMaster University|
|Principal Investigator:||Terence Ho, MD, FRCP||McMaster University|
|Principal Investigator:||Andrew P Costa, PhD||McMaster University|
|Principal Investigator:||Marla Beauchamp, PhD||McMaster University|
|Principal Investigator:||Jennifer Tsang, MD, PhD, FRCPC||McMaster University|