The RIsk Stratification in COVID-19 Patients in the ICU Registry (RISC-19-ICU)

• ClinicalTrials.gov Identifier: NCT04357275
• Recruitment Status: Unknown
• First Posted: April 22, 2020
• Last Update Posted: April 22, 2020
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

Study Description

Brief Summary:

The Risk stratification in COVID-19 patients in the ICU (RISC-19-ICU) registry was founded during the emerging SARS-CoV-2 pandemic. COVID-19 is a novel disease caused by infection with the SARS-CoV-2 virus that was first described in December 2019. The disease has spread exponentially in many countries and has reached global pandemic status within three months. According to first experience, hospitalization was required in approximately 20 % of cases and severe, life-threatening illness resulted in approximately 10 %. In some countries, health care systems were overwhelmed by the rapid increase in critically ill patients that far exceeded their capacity. It is thus of utmost importance to gain knowledge about the characteristics and course of critically ill patients with COVID-19 and to stratify these patients according to their risk for further deterioration. A key part of fighting this pandemic is to exchange scientific information and advance our understanding of the disease.

The Risk stratification in COVID-19 patients in the ICU (RISC-19-ICU) registry aims to collect an anonymized dataset to characterize patients that develop life-threatening critical illness due to COVID-19 and make it accessible to collaborative analysis.

The data collected may be composed of a core dataset and/or an extended dataset. The core dataset consists of a basic set of parameters, of which many are commonly generated during treatment of critically ill patients with COVID-19 in an intensive care unit (the individual parameters are marked yellow in the attached case report forms, and are clearly marked on the electronic case report forms during data entry). The extended dataset consists of parameters that may be measured during treatment of critically ill patients with COVID-19 in an intensive care unit, depending on clinical practice, indication and availability of the measurement method. The data accumulating in the registry as the pandemic or subsequent waves develop are made available to the collaborators to support an optimal response to the pandemic threat. The information gained on the initial characteristics and disease course via the RISC-19-ICU registry may contribute to a better understanding of the risk factors for developing critical illness due to COVID-19 and for an unfavorable disease course, and thus support informed patient triage and management decisions.

Initial research questions are (I) to perform risk stratification of critically ill patients with COVID-19 to find predictors associated with the development of critical illness due to COVID-19: characterization of the study population, which are critically ill patients with COVID-19: inflammation, oxygenation, circulatory function, among other parameters collected in the registry, and (II) to perform risk stratification of critically ill patients with COVID-19 to predict outcome after ICU admission (ICU mortality, ICU length of stay): characterization of patients grouped by disease course in the ICU, based on inflammation, oxygenation, circulatory function, and other parameters collected in the registry.

Condition or disease	Intervention/treatment
Critical Illness; ARDS; Inflammatory Response; COVID-19; Circulatory Shock	Other: ICU treatment

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 4 Weeks
• Official Title: The RIsk Stratification in COVID-19 Patients in the ICU Registry
• Actual Study Start Date: March 13, 2020
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: March 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
ICU admissions due to COVID-19	Other: ICU treatment; ICU treatment according to standard of care

Outcome Measures

Primary Outcome Measures :

1. ICU mortality [ Time Frame: During inclusion period ]

Secondary Outcome Measures :

1. Hospital mortality [ Time Frame: During inclusion period ]
2. ICU length of stay [ Time Frame: During inclusion period ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an intensive care unit in a collaborating center due to COVID-19

Criteria

Inclusion Criteria:

• Admission to an intensive care unit in a collaborating center due to COVID-19

Exclusion Criteria:

• Missing ethical approval

Contacts and Locations

Contacts

Contact: Matthias P Hilty, MD; +41 44 255 11 11; matthias.hilty@usz.ch

Locations

Switzerland

University Hospital of Zurich; Recruiting

Zurich, Switzerland, 8091

Contact: Dorothea Heuberger, PhD

Sponsors and Collaborators

University of Zurich

Investigators

• Principal Investigator: Matthias P Hilty, MD; RISC-19-ICU board
• Study Chair: Pedro D Wendel Garcia, MSc; RISC-19-ICU board
• Study Chair: Reto A Schüpbach, MD; RISC-19-ICU board
• Study Chair: Jonathan Montomoli, MD, PhD; RISC-19-ICU board
• Study Chair: Philippe Guerci, MD; RISC-19-ICU board
• Study Chair: Theirry Fumeaux, MD; RISC-19-ICU board

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wendel-Garcia PD, Moser A, Jeitziner MM, Aguirre-Bermeo H, Arias-Sanchez P, Apolo J, Roche-Campo F, Franch-Llasat D, Kleger GR, Schrag C, Pietsch U, Filipovic M, David S, Stahl K, Bouaoud S, Ouyahia A, Fodor P, Locher P, Siegemund M, Zellweger N, Cereghetti S, Schott P, Gangitano G, Wu MA, Alfaro-Farias M, Vizmanos-Lamotte G, Ksouri H, Gehring N, Rezoagli E, Turrini F, Lozano-Gomez H, Carsetti A, Rodriguez-Garcia R, Yuen B, Weber AB, Castro P, Escos-Orta JO, Dullenkopf A, Martin-Delgado MC, Aslanidis T, Perez MH, Hillgaertner F, Ceruti S, Franchitti Laurent M, Marrel J, Colombo R, Laube M, Fogagnolo A, Studhalter M, Wengenmayer T, Gamberini E, Buerkle C, Buehler PK, Keiser S, Elhadi M, Montomoli J, Guerci P, Fumeaux T, Schuepbach RA, Jakob SM, Que YA, Hilty MP; RISC-19-ICU Investigators. Dynamics of disease characteristics and clinical management of critically ill COVID-19 patients over the time course of the pandemic: an analysis of the prospective, international, multicentre RISC-19-ICU registry. Crit Care. 2022 Jul 4;26(1):199. doi: 10.1186/s13054-022-04065-2.

Hilty MP, Moser A, David S, Wendel Garcia PD, Capaldo G, Keiser S, Fumeaux T, Guerci P, Montomoli J, Van Boeckel TP, Jeitziner MM, Que YA, Jakob S, Schupbach RA; RISC-19-ICU Investigators for Switzerland. Near real-time observation reveals increased prevalence of young patients in the ICU during the emerging third SARS-CoV-2 wave in Switzerland. Swiss Med Wkly. 2021 Jul 21;151:Swiss Med Wkly. 2021;151:w20553. doi: 10.4414/smw.2021.20553. eCollection 2021 Jul 19.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04357275
• Other Study ID Numbers: KEK-ZH-req-2020-00322
• First Posted: April 22, 2020
• Last Update Posted: April 22, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

• Each collaborator's data is available for their own use
• The collaborators are encouraged to share their analysis code (the standard is R code)
• Analysis on the entire registry dataset may be performed using the same analysis pathway. To request analysis on the entire dataset, a protocol may be submitted to the board
• The board may make some descriptive data publicly available to support the coordination of the response to the pandemic threat
• Scientific findings will be jointly published in a scientific journal according to a collaboration agreement

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Critical Illness; Shock; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes