Prognostic Factors in Patients Admitted to an Urban Teaching Hospital With COVID-19 Infection

NCT04484545 | Unknown

• 1 other identifier: IRAS 282807
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

As of 27th May 2020, approximately 5.7 million people worldwide are known to have been infected with COVID-19 coronavirus and more than 350,000 have died (1). The severity of this viral disease for an individual is associated with a widespread perturbation of immune, physiological and metabolic parameters (2, 3). These whole body changes could be considered characteristic of a systemic inflammatory response to tissue injury and it has been long recognised that a large and ongoing systemic inflammatory response is associated with the development of multiple organ failure and infective disease (4, 5). One of the cardinal signs of severe COVID-19 infection is a marked systemic inflammatory response (2). This response bears striking similarity to the systemic inflammatory response experienced by patients undergoing major elective surgical resections for cancer (6, 7). Indeed, the systemic inflammatory response and the associated metabolic stress has been most well characterised in major elective surgery, where the relationship between the magnitude of the post-operative systemic inflammatory response and the development of post-operative complications is now well recognised, as is the effect of patient comorbidity on this relationship (8, 9). Such work has informed therapeutic manoeuvres including minimally invasive surgery, pre-operative optimisation (e.g. anaesthesia, nutrition and steroids) and enhanced recovery protocols. The aim of the present study was to examine whether routinely collected clinicopathological characteristics of patients with COVID-19 on admission were informative on the immune and metabolic stress experienced by patients with COVID-19 and whether such characteristics were informative on subsequent outcome.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• mortality

  30-day mortality and prognostic score

  30-day

Study Arms (1)

Alive or Dead with COVID-19 diagnosis

Patients selected in phase 1 of study according to Health Protection Scotland criteria for diagnosis of COVID-19 infection Patients selected for phase 2 (validation phase) by PCR result

Diagnostic Test: Prognostic score

Interventions

Prognostic score DIAGNOSTIC_TEST

Validation of scores of systemic inflammatory response

Alive or Dead with COVID-19 diagnosis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General hospital population

You may qualify if:

• Clinical, radiological and PCR positive COVID-19 diagnosis

You may not qualify if:

• less than 18 years old

Sponsors & Collaborators

• Glasgow Royal Infirmary: lead

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

Related Publications (2)

• McGovern J, Al-Azzawi Y, Kemp O, Moffitt P, Richards C, Dolan RD, Laird BJ, McMillan DC, Maguire D. The relationship between frailty, nutritional status, co-morbidity, CT-body composition and systemic inflammation in patients with COVID-19. J Transl Med. 2022 Feb 21;20(1):98. doi: 10.1186/s12967-022-03300-2.

  PMID: 35189900 DERIVED

• Maguire D, Richards C, Woods M, Dolan R, Wilson Veitch J, Sim WMJ, Kemmett OEH, Milton DC, Randall SLW, Bui LD, Goldmann N, Brown A, Gillen E, Cameron A, Laird B, Talwar D, Godber IM, Wadsworth J, Catchpole A, Davidson A, McMillan DC. The systemic inflammatory response and clinicopathological characteristics in patients admitted to hospital with COVID-19 infection: Comparison of 2 consecutive cohorts. PLoS One. 2021 May 27;16(5):e0251924. doi: 10.1371/journal.pone.0251924. eCollection 2021.

  PMID: 34043668 DERIVED

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Donogh Maguire, PhD

  NHS GGC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Consultant

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 23, 2020
• Study Start: April 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months

Locations

GB (1)