Clinical trial NCT04508959: The McMaster Multi-Regional COVID-19 Hospital Case Registry
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infection
Coronavirus
SARS-CoV-2 Infection
Covid19
Keywords: Registry
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Hamilton Academic Health Sciences Organization
name: Grand River Hospital
name: Niagara Health System
name: St. Mary's General Hospital
name: Hamilton Health Sciences Corporation
name: St. Joseph's Healthcare Hamilton
First posted: 2020-08-11
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Persons tested positive for SARS-CoV-2 using hospital facilities
* Patients seen or admitted with confirmed COVID-19 to the hospital

Brief summary: The McMaster Multi-Regional Hospital Coronavirus Registry (COREG) is a platform that is collecting detailed case data on laboratory confirmed COVID-19 hospital inpatients and outpatients. The COREG platform will provide rapid high-quality evidence to improve the prevention and clinical management of COVID-19 for older adults in Canada, and internationally. The COREG platform will also provide researchers and partners with complete regional level clinical data on COVID-19 cases to inform rapid decision-making and projections, sub-studies, extensions, and linkage for all affected populations.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Persons tested positive for SARS-CoV-2 using hospital facilities
* Patients seen or admitted with confirmed COVID-19 to the hospital

Exclusion Criteria:

* The pragmatic nature of the registry warrants the broadest inclusion criteria that are feasible. In keeping with the pragmatic nature of this registry, no exclusions are introduced.

Primary outcomes:
measure: Serious COVID-19 infection
timeFrame: through study completion, an average of 1 year
measure: Severe infection (requiring admission)
timeFrame: through study completion, an average of 1 year
measure: COVID-19 related death
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Length of stay
timeFrame: through study completion, an average of 1 year
measure: Complications
timeFrame: through study completion, an average of 1 year
measure: Intensive interventions
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: Kitchener
country: Canada
facility: St. Mary's General Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System
state: Ontario
Study officials:
affiliation: McMaster University
name: Rebecca J Kruisselbrink, MD, MPH, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: MyLinh Duong, MBBS, MSc, FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Terence Ho, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Andrew P Costa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Marla Beauchamp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Jennifer Tsang, MD, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: