COVID-19NCT04484545
Prognostic Factors in Patients Admitted to an Urban Teaching Hospital With COVID-19 Infection
An observational study of COVID-19, run by Glasgow Royal Infirmary at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Prognostic score
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2020to 1 Jun 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General hospital population
Who may be able to join
- Clinical, radiological and PCR positive COVID-19 diagnosis
Who cannot join
- less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- COVID-19
- Being tested
- Prognostic score
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic scoreDiagnostic test
Validation of scores of systemic inflammatory response
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Prognostic score |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
30-day mortality and prognostic score
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Apr 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Royal Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Donogh Maguire, Glasgow Royal Infirmary
- Investigators
- Donogh Maguire, PhD, Principal investigator, NHS GGC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484545
- Sponsor's protocol ID
- IRAS 282807
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised patient data will be made available on reasonable request
Publications
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.
PubMed 35189900Maguire 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.
PubMed 34043668
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors in Patients Admitted to an Urban Teaching Hospital With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04484545
- Acronym / sponsor ID
- IRAS 282807
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Glasgow Royal InfirmaryUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 23 Jul 2020 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alive or Dead with COVID-19 diagnosis | – | Diagnostic Test: Prognostic scorePatients 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General hospital population
Key inclusion criteria (1 listed)
- Clinical, radiological and PCR positive COVID-19 diagnosis
Key exclusion criteria (1 listed)
- less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognostic scoreValidation of scores of systemic inflammatory response | Diagnostic test | Alive or Dead with COVID-19 diagnosis |
Primary outcome
mortality
Time frame: 30-day
30-day mortality and prognostic score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Derived from this study: PubMed 35189900McGovern 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.
- Derived from this study: PubMed 34043668Maguire 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.
- Individual participant dataSharing planned: Yes. Anonymised patient data will be made available on reasonable request
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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.
Donogh Maguire, PhD principal investigator
NHS GGC
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, run by Glasgow Royal Infirmary at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. 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 United Kingdom. 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?
Results are not available in the source record.
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?
mortality (time frame: 30-day). 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 NCT04484545, which also lists 2 linked publications.
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 23 Jul 2020.