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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04484545
• Other study ID #: IRAS 282807
• Status: Active, not recruiting
• Start date: April 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2020
• Source: Glasgow Royal Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Electronic patient records for patients who attended the Emergency Department (ED) and Acute Assessment Unit (AAU) at Glasgow Royal Infirmary (GRI), Glasgow, U.K., during the initial 7-week period of the COVID-19 pandemic in Glasgow city (17th March 2020 - 1st May 2020) were examined for routine clinical, laboratory and clinical outcome data. GRI is a university teaching hospital that serves an urban population with a high burden of socio-economic deprivation and offers the full spectrum of adult acute receiving specialties to patients over 16 years old. In line with NHS policy, this study was approved by the NHS Greater Glasgow and Clyde Caldicott guardian.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Clinical, radiological and PCR positive COVID-19 diagnosis

Exclusion Criteria:

• less than 18 years old

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Diagnostic Test:
• Prognostic score
Validation of scores of systemic inflammatory response

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Glasgow Royal Infirmary

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	30-day mortality and prognostic score	30-day