Chronic Multimorbidity Patterns in Relation to COVID-19 Severe Infection

Covid-19 Clinical Trial

— Mrisk-COVID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981249
• Other study ID #: CIR 2020/023
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2021
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14286
• Est. completion date: May 31, 2021
• Est. primary completion date: January 31, 2021
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

Inclusion Criteria:

• Positive results of Covid-19 laboratory tests

• Covid-19 related clinical profile verified by healthcare professionals

Exclusion Criteria:

• Male >90 years

• Females >95 years

Related Conditions & MeSH terms

• Chronic Disease
• Covid-19

Locations

Country	Name	City	State
Spain	Corporacio Parc Taulí	Sabadell

Sponsors (3)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Agència de Qualitat i Avaluació Sanitàries, Instituto Aragones de Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From 27-February-2020 to 15-June-2020
Primary	Covid-19 mortality	Death associated to COVID-19 infection episode	From 27-February-2020 to 15-June-2020

External Links

•   Agency for Healthcare Research and Quality. Rockville. MD. Healthcare Cost and Utilization Project (HCUP)