Covid-19Mrisk-COVIDNCT04981249
Chronic Multimorbidity Patterns in Relation to COVID-19 Severe Infection
An observational study of Covid-19 and Chronic Disease, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The aim of the study was to analyze the patterns of chronic multimorbidity of a cohort of Covid-19 patients, and to assess the relation between the patterns and the development of severe infection or mortality. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Covid-19, Chronic Disease
- How many people
- 14,286 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 31 May 2021
- 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 21 to 95 years
- All sexes
- Adult, Older adult
Study population: Confirmed or suspected Covid-19 patients from the first wave of the pandemic, aged >20 years, residing in a healthcare region of about 400.000 inhabitants in a Northeast region of Spain (Vallès Occidental Est, Catalonia, Spain).
Who may be able to join
- Positive results of Covid-19 laboratory tests
- Covid-19 related clinical profile verified by healthcare professionals
Who cannot join
- Male >90 years
- Females >95 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Severe COVID-19, Taking Into Account Multimorbidity Patterns, as Well as Other Clinical and Sociodemographic Variables. Big Data Mrisk-COVID Project
The aim of the study was to analyze the patterns of chronic multimorbidity of a cohort of Covid-19 patients, and to assess the relation between the patterns and the development of severe infection or mortality.
Read the detailed description
This is a Big Data study that aims to establish the multimorbidity (MM) clusters of a cohort of Covid-19 patients, and assess their potential relation with severe infection or mortality. Databases of demographic information and complete medical records from the cohort will be provided by the Agency for Health Quality and Assessment of Catalonia (AQuAS). Data will be collected and integrated in a complete database in order to define the study variables: multimorbidity patterns, COVID-19 severe infection and COVID-19 associated mortality. The population will be stratified by sex and age (21-45, 46-65, 66-80 and 81-95 years). Diagnoses from primary care and hospitals will be filtered and classified using the Chronic Condition Indicator v.2021 and the Clinical Classification Software v.2021 [1], in order to identify the Chronic Conditions (CC) of the patients. CC with prevalence >2% in each age-sex strata will be subjected to a fuzzy c-means clustering analysis. The final number of clusters in each age-sex group will be determined under the clinical criteria of the research group members. Percentages of patients that suffered severe Covid-19 infection or death in each cluster will be calculated. Bivariate statistical analysis comparing the demographic data and the cluster distribution with severe infection and mortality will be performed.
- Conditions
- Covid-19, Chronic Disease
- Keywords
- Multimorbidity, Cluster analysis, Covid-19
- Medical subject headings
- COVID-19, Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 severe infection
Severe COVID-19 infection was defined as the occurrence of at least one of the following conditions during any of the registered COVID-19 episodes: severe respiratory affection (including insufficiency, failure, or distress); use of respiratory support (including mechanical ventilation or oxygen therapy); septic shock; multiple organ failure (the combination of respiratory failure and any other organ failure); inflammatory response; admission to intensive care unit; and mortality.
Measured: From 27-February-2020 to 15-June-2020
Covid-19 mortality
Death associated to COVID-19 infection episode
Measured: From 27-February-2020 to 15-June-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jan 2021
- Primary completion31 Jan 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 14,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Agència de Qualitat i Avaluació Sanitàries, Instituto Aragones de Ciencias de la Salud
- Responsible party
- Principal investigator, Marisa Baré, MD, MPH, PhD, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981249
- Sponsor's protocol ID
- CIR 2020/023
- Acronym
- Mrisk-COVID
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lleal M, Corral-Vazquez C, Bare M, Comet R, Herranz S, Baigorri F, Gimeno-Miguel A, Raurich M, Fortia C, Navarro M, Poblador-Plou B, Bare M. Multimorbidity patterns in COVID-19 patients and their relationship with infection severity: MRisk-COVID study. PLoS One. 2023 Aug 31;18(8):e0290969. doi: 10.1371/journal.pone.0290969. eCollection 2023.
PubMed 37651465
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Severe COVID-19, Taking Into Account Multimorbidity Patterns, as Well as Other Clinical and Sociodemographic Variables. Big Data Mrisk-COVID Project
- ClinicalTrials.gov ID
- NCT04981249
- Acronym / sponsor ID
- Mrisk-COVID / CIR 2020/023
- Conditions
- Covid-19, Chronic Disease
- Keywords
- Multimorbidity, Cluster analysis, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,286 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Agència de Qualitat i Avaluació Sanitàries, Instituto Aragones de Ciencias de la Salud
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 28 Jul 2021 (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 aim of the study was to analyze the patterns of chronic multimorbidity of a cohort of Covid-19 patients, and to assess the relation between the patterns and the development of severe infection or mortality.
Detailed description
This is a Big Data study that aims to establish the multimorbidity (MM) clusters of a cohort of Covid-19 patients, and assess their potential relation with severe infection or mortality. Databases of demographic information and complete medical records from the cohort will be provided by the Agency for Health Quality and Assessment of Catalonia (AQuAS). Data will be collected and integrated in a complete database in order to define the study variables: multimorbidity patterns, COVID-19 severe infection and COVID-19 associated mortality. The population will be stratified by sex and age (21-45, 46-65, 66-80 and 81-95 years). Diagnoses from primary care and hospitals will be filtered and classified using the Chronic Condition Indicator v.2021 and the Clinical Classification Software v.2021 [1], in order to identify the Chronic Conditions (CC) of the patients. CC with prevalence >2% in each age-sex strata will be subjected to a fuzzy c-means clustering analysis. The final number of clusters in each age-sex group will be determined under the clinical criteria of the research group members. Percentages of patients that suffered severe Covid-19 infection or death in each cluster will be calculated. Bivariate statistical analysis comparing the demographic data and the cluster distribution with severe infection and mortality will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Confirmed or suspected Covid-19 patients from the first wave of the pandemic, aged >20 years, residing in a healthcare region of about 400.000 inhabitants in a Northeast region of Spain (Vallès Occidental Est, Catalonia, Spain).
Key inclusion criteria (2 listed)
- Positive results of Covid-19 laboratory tests
- Covid-19 related clinical profile verified by healthcare professionals
Key exclusion criteria (2 listed)
- Male >90 years
- Females >95 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Covid-19 severe infection
Time frame: From 27-February-2020 to 15-June-2020
Severe COVID-19 infection was defined as the occurrence of at least one of the following conditions during any of the registered COVID-19 episodes: severe respiratory affection (including insufficiency, failure, or distress); use of respiratory support (including mechanical ventilation or oxygen therapy); septic shock; multiple organ failure (the combination of respiratory failure and any other organ failure); inflammatory response; admission to intensive care unit; and mortality.
Covid-19 mortality
Time frame: From 27-February-2020 to 15-June-2020
Death associated to COVID-19 infection episode
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 37651465Lleal M, Corral-Vazquez C, Bare M, Comet R, Herranz S, Baigorri F, Gimeno-Miguel A, Raurich M, Fortia C, Navarro M, Poblador-Plou B, Bare M. Multimorbidity patterns in COVID-19 patients and their relationship with infection severity: MRisk-COVID study. PLoS One. 2023 Aug 31;18(8):e0290969. doi: 10.1371/journal.pone.0290969. eCollection 2023.
- Agency for Healthcare Research and Quality. Rockville. MD. Healthcare Cost and Utilization Project (HCUP)Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid-19 and Chronic Disease, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Aug 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Covid-19 severe infection (time frame: From 27-February-2020 to 15-June-2020). The study lists 2 primary outcomes in all. 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 NCT04981249, which also lists 1 linked publication.
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 4 Aug 2021.