Comorbidities and Risk Score in COVID-19 Patients

NCT04670094 | Completed DMC

• 1 other identifier: Comorbidities
• Study Type: observational
• Target: 4,555
• Locations: 1 country
• Sites: 5

Brief Summary

Retrospective multi-center cohort study. Consecutive patients hospitalized for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) up to October 2020 will be included. Patients are followed until discharge from hospital or death.

Conditions

Covid19

Keywords

SARS-CoV-2; Hypertension; Pregnancy; corticosteroids; immunosuppressive medications; Cancer; Chronic kidney disease; COPD; Heart conditions; Obesity; Severe Obesity; Sickle cell disease; Smoking; Solid organ transplantation; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• In-hospital mortality

  Description of the hospital mortality caused by the COVID19 disease

  Until study completion, an average of 1 year

• Mortality up to 3 months from admission

  Description of the mortality patients up to 3 months from admission

  Until study completion, an average of 1 year

Secondary Outcomes (3)

• Admission to Intensive care unit (ICU)

  Until study completion, an average of 1 year

• Complications occurred during the hospital course

  Until study completion, an average of 1 year

• Correlation between admission to ICU and in-hospital mortality

  Until study completion, an average of 1 year

Study Arms (1)

Covid19 infection related patients

Patients over the age of 18 hospitalized for SARS-CoV-2 up to end of June 2020 in the San Gerardo Hospital and other centers will be included. Patients are followed until discharge from hospital or death.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients who had a diagnosis of SARS-CoV-2 infection up to October 2020 at the San Gerardo Hospital in Monza and at other centers participating in the study will be enrolled in this study.

You may qualify if:

• the presence of SARS-CoV-2 infection
• age \>18 years,
• diagnosis of SARS-CoV-2 infection up to October 2020

You may not qualify if:

• None

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (5)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Location

ASST Spedali Civili

Montichiari, Italy

Location

ASST Monza-Ospedale San Gerardo

Monza, Italy

Location

Humanitas Clinical and Research Hospital

Rozzano, Italy

Location

Centre for Tropical and Infectious Diseases and Microbiology, IRCCS Sacro Cuore

Verona, Italy

Location

Related Publications (6)

• Chen R, Liang W, Jiang M, Guan W, Zhan C, Wang T, Tang C, Sang L, Liu J, Ni Z, Hu Y, Liu L, Shan H, Lei C, Peng Y, Wei L, Liu Y, Hu Y, Peng P, Wang J, Liu J, Chen Z, Li G, Zheng Z, Qiu S, Luo J, Ye C, Zhu S, Liu X, Cheng L, Ye F, Zheng J, Zhang N, Li Y, He J, Li S, Zhong N; Medical Treatment Expert Group for COVID-19. Risk Factors of Fatal Outcome in Hospitalized Subjects With Coronavirus Disease 2019 From a Nationwide Analysis in China. Chest. 2020 Jul;158(1):97-105. doi: 10.1016/j.chest.2020.04.010. Epub 2020 Apr 15.

  PMID: 32304772 BACKGROUND

• Zheng Z, Peng F, Xu B, Zhao J, Liu H, Peng J, Li Q, Jiang C, Zhou Y, Liu S, Ye C, Zhang P, Xing Y, Guo H, Tang W. Risk factors of critical & mortal COVID-19 cases: A systematic literature review and meta-analysis. J Infect. 2020 Aug;81(2):e16-e25. doi: 10.1016/j.jinf.2020.04.021. Epub 2020 Apr 23.

  PMID: 32335169 BACKGROUND

• Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.

  PMID: 32173574 BACKGROUND

• Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.

  PMID: 32219356 BACKGROUND

• Lighter J, Phillips M, Hochman S, Sterling S, Johnson D, Francois F, Stachel A. Obesity in Patients Younger Than 60 Years Is a Risk Factor for COVID-19 Hospital Admission. Clin Infect Dis. 2020 Jul 28;71(15):896-897. doi: 10.1093/cid/ciaa415. No abstract available.

  PMID: 32271368 BACKGROUND

• Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10.

  PMID: 32271993 BACKGROUND

MeSH Terms

Conditions

COVID-19; Hypertension; Neoplasms; Renal Insufficiency, Chronic; Pulmonary Disease, Chronic Obstructive; Obesity; Obesity, Morbid; Anemia, Sickle Cell; Smoking; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Maria Grazia Valsecchi, Prof.

  University of Milano Bicocca

  STUDY CHAIR

• llaria Capua, Prof.

  University of Florida

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 17, 2020
• Study Start: December 30, 2020
• Primary Completion: May 29, 2021
• Study Completion: May 29, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)