Critical IllnessRISC-19-ICUNCT04357275
The RIsk Stratification in COVID-19 Patients in the ICU Registry
An observational study of Critical Illness and ARDS, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, ARDS, Inflammatory Response
- What is being tested?
- ICU treatment
- How many people
- 10,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Mar 2020to Dec 2025
- How long will I take part?
- 4 Weeks
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to an intensive care unit in a collaborating center due to COVID-19
Who may be able to join
- Admission to an intensive care unit in a collaborating center due to COVID-19
Who cannot join
- Missing ethical approval
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Critical Illness, ARDS, Inflammatory Response, COVID-19, Circulatory Shock
- Being tested
- ICU treatment
- Medical subject headings
- Critical Illness, COVID-19, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU treatmentOther
ICU treatment according to standard of care
| Study group | Role | What they receive |
|---|---|---|
| ICU admissions due to COVID-19 | Not described Receives: Other: ICU treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Measured: During inclusion period
Secondary outcomes (2)
Hospital mortality
Measured: During inclusion period
ICU length of stay
Measured: During inclusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start13 Mar 2020
- Primary completion31 Dec 2022
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias P Hilty, MD, Principal investigator, RISC-19-ICU boardPedro D Wendel Garcia, MSc, Study chair, RISC-19-ICU boardReto A Schüpbach, MD, Study chair, RISC-19-ICU boardJonathan Montomoli, MD, PhD, Study chair, RISC-19-ICU boardPhilippe Guerci, MD, Study chair, RISC-19-ICU boardTheirry Fumeaux, MD, Study chair, RISC-19-ICU board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357275
- Sponsor's protocol ID
- KEK-ZH-req-2020-00322
- Acronym
- RISC-19-ICU
- Status last verified
- Dec 2023
- First submitted
- 15 Apr 2020
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * 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
Publications
Arias-Sanchez PP, Wendel-Garcia PD, Tirape-Castro HA, Cobos J, Jaramillo-Aguilar SX, Penaloza-Tinoco AM, Jaramillo-Aguilar DS, Martinez A, Holguin-Carvajal JP, Cabrera E, Roche-Campo F, Aguirre-Bermeo H. Use of a gas-operated ventilator as a noninvasive bridging respiratory therapy in critically Ill COVID-19 patients in a middle-income country. Intern Emerg Med. 2025 Mar;20(2):543-551. doi: 10.1007/s11739-024-03681-w. Epub 2024 Jun 28.
PubMed 38940989Wendel-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.
PubMed 35787726Hilty 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.
PubMed 34291810
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RIsk Stratification in COVID-19 Patients in the ICU Registry
- ClinicalTrials.gov ID
- NCT04357275
- Acronym / sponsor ID
- RISC-19-ICU / KEK-ZH-req-2020-00322
- Conditions
- Critical Illness, ARDS, Inflammatory Response, COVID-19, Circulatory Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Apr 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU admissions due to COVID-19 | – | Other: ICU treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to an intensive care unit in a collaborating center due to COVID-19
Key inclusion criteria (1 listed)
- Admission to an intensive care unit in a collaborating center due to COVID-19
Key exclusion criteria (1 listed)
- Missing ethical approval
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 |
|---|---|---|
| ICU treatmentICU treatment according to standard of care | Other | ICU admissions due to COVID-19 |
Primary outcome
ICU mortality
Time frame: During inclusion period
2 secondary outcomes
Hospital mortality
Time frame: During inclusion period
ICU length of stay
Time frame: During inclusion period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Derived from this study: PubMed 38940989Arias-Sanchez PP, Wendel-Garcia PD, Tirape-Castro HA, Cobos J, Jaramillo-Aguilar SX, Penaloza-Tinoco AM, Jaramillo-Aguilar DS, Martinez A, Holguin-Carvajal JP, Cabrera E, Roche-Campo F, Aguirre-Bermeo H. Use of a gas-operated ventilator as a noninvasive bridging respiratory therapy in critically Ill COVID-19 patients in a middle-income country. Intern Emerg Med. 2025 Mar;20(2):543-551. doi: 10.1007/s11739-024-03681-w. Epub 2024 Jun 28.
- Derived from this study: PubMed 35787726Wendel-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.
- Derived from this study: PubMed 34291810Hilty 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.
- Individual participant dataSharing planned: Yes. * 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
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Matthias P Hilty, MD principal investigator
RISC-19-ICU board
Pedro D Wendel Garcia, MSc study chair
RISC-19-ICU board
Reto A Schüpbach, MD study chair
RISC-19-ICU board
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 Critical Illness and ARDS, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 1 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 22 Dec 2023. 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 Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: During inclusion period). 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 NCT04357275, which also lists 3 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 22 Dec 2023.