Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04508959 |
| Other study ID # |
172754 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2020 |
| Est. completion date |
July 2021 |
Study information
| Verified date |
November 2020 |
| Source |
McMaster University |
| Contact |
Andrew P Costa, PhD |
| Phone |
5197296285 |
| Email |
acosta[@]mcmaster.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
