COVIDNCT04416347
COVID19 Clinical Predictors and Outcome
An observational study of COVID and SARS-CoV 2, run by St George's University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In December 2019, a novel coronavirus (SARS-CoV-2) emerged in Wuhan, Hubei, China, and now spreads across international borders. As of 11 April 2020, the total global number of confirmed SARS-CoV-2 cases reached 1,521,252 (92,798 deaths); with 65,081 (7,978 deaths) being reported in the United Kingdom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, SARS-CoV 2
- What is being tested?
- SARS-CoV2 Infection
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2020to 30 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population for workstream 1, will comprise adults (>=18years) with or without laboratory confirmed SARS-CoV-2 infection admitted to SGHFT between 01 December 2019 and 30 April 2022. The study population for workstream 2, will comprise adults (>=18years) with respiratory failure (all causes) admitted to intensive care between 01 December 2019 and 30 April 2022.
Who may be able to join
- Adults (aged ≥18 years).
- Patients attending SGHFT.
- Adult (aged ≥18 years) patients admitted to ICU areas during the period of study
- Presence of acute respiratory failure: this is defined by meeting all the following criteria:
- Onset over 1 week or less
- Presence of consolidation, or bilateral opacities on CT or chest radiograph.
- PaO2 < 8 kPa on FiO2 0.21 or requirement of non-invasive ventilation (NIV), high-flow nasal cannula (HFNC) or mechanical ventilation
Who cannot join
- Children and adolescents (< 18 years). Workstream 2
- Respiratory symptoms explained by cardiac failure or fluid overload alone
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St. George's University Hospitals Foundation Trust.
London, SW17 0RE
Timothy D Planche, Dr., 02087252683
About this study
Official title: COVID-19, Clinical Predictors and Evolution of Disease in Hospitalised and Intensive Care Patients at St George's Hospital
In December 2019, a novel coronavirus (SARS-CoV-2) emerged in Wuhan, Hubei, China, and now spreads across international borders. As of 11 April 2020, the total global number of confirmed SARS-CoV-2 cases reached 1,521,252 (92,798 deaths); with 65,081 (7,978 deaths) being reported in the United Kingdom.
COVID-19 is the name of the disease associated with SARS-CoV-2 infection and includes a spectrum of illness that ranges from mild infection to severe pneumonia that can progress to respiratory failure and Acute Respiratory Distress Syndrome (ARDS) or septic shock. Between 8 to 15% (depending on geographical setting) of all SARS-CoV-2 positive cases can be classified as severe or necessitating intensive care unit (ICU) admission.
Read more
In the early stages of the outbreak unfolding, several retrospective case studies and cases series carried out in China reported that those who died were more likely to be male, and more likely to have underlying comorbidities. Prevalence studies conducted in the US and Italy show similar trends in the distribution of comorbidities among SARS-CoV-2 severe cases; adding obesity (BMI>30) to the list of factors potentially associated with disease severity. However, the relative importance of different underlying health conditions remains unclear owing to inadequate adjustment for important confounding factors such as age, sex, and smoking status.
We propose a cohort study to evaluate predictors, clinical evolution and excess of mortality of SARS-CoV-2 in hospitalised patients, with two main workstreams- the first looking at all patients admitted to SGHFT and the second looking at patients admitted to ITU with respiratory failure.
Read the detailed description
The majority of published reports on early clinical descriptions of COVID-19 have emerged from Hubei province in China, and although these provide valuable information, the lack of standardised mortality and morbidity ratios hinders comparison of outcome experience across populations. Also, most of the data available originate from descriptive cases or series that do not account for confounding effect; so, as yet there are no specific data on how the risks associated with underlying comorbidities might vary in different population groups or settings.
Recognition of risk factors for morbidity and mortality is important to determine prevention strategies as well as to target high-risk populations for potential therapeutics. So, in this study we aim to develop a predictive statistical model to identify baseline predictors of mortality including underlying health conditions and biomarker levels at admission to improve the understanding of the clinical evolution of patients with severe COVID-19.
An approximative 20-30% of regular admissions in the ICU are with respiratory failure. A considerably higher number is expected in the current climate. Government policies have aimed to flatten the epidemic curve to ease the pressure on the NHS to ensure as many people as possible have access to the appropriate level of intensive care. However, even in the best-case scenario, the number of people requiring level 3 care in ICU may be ten times the current capacity.
The excess of mortality due to SARS-CoV-2 in this population hasn't been fully assessed. It is unknown if the evolution of this disease shares common characteristics with other bacterial or viral infections. This information is invaluable in order to shape diagnostic protocols, prevent complications and design therapeutic strategies.
- Conditions
- COVID, SARS-CoV 2
- Being tested
- SARS-CoV2 Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV2 InfectionOther
Laboratory confirmed SARS-CoV2
| Study group | Role | What they receive |
|---|---|---|
| Workstream 1 | Adult patients admitted to SGHFT (St. Georges Hospital Foundation Trust) with or without laboratory confirmed SARS- CoV-2. Receives: Other: SARS-CoV2 Infection | |
| Workstream 2 | Adult patients admitted to to SGHFT (St. Georges Hospital Foundation Trust) ITU with respiratory failure. Receives: Other: SARS-CoV2 Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 hospital mortality
To assess mortality in SARS-CoV-2 patients admitted to SGHFT wards.
Measured: 6 months from admission
SARS-CoV-2 mortality in critical care unit
To assess the risk of death attributable to COVID-19, in comparison with non-Covid-19, in patients admitted to critical care with respiratory failure.
Measured: 6 months from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Jun 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416347
- Sponsor's protocol ID
- 2020.0115
- Status last verified
- Oct 2020
- First submitted
- 6 May 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19, Clinical Predictors and Evolution of Disease in Hospitalised and Intensive Care Patients at St George's Hospital
- ClinicalTrials.gov ID
- NCT04416347
- Acronym / sponsor ID
- 2020.0115
- Conditions
- COVID, SARS-CoV 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- St George's University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 4 Jun 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.
In December 2019, a novel coronavirus (SARS-CoV-2) emerged in Wuhan, Hubei, China, and now spreads across international borders. As of 11 April 2020, the total global number of confirmed SARS-CoV-2 cases reached 1,521,252 (92,798 deaths); with 65,081 (7,978 deaths) being reported in the United Kingdom.
COVID-19 is the name of the disease associated with SARS-CoV-2 infection and includes a spectrum of illness that ranges from mild infection to severe pneumonia that can progress to respiratory failure and Acute Respiratory Distress Syndrome (ARDS) or septic shock. Between 8 to 15% (depending on geographical setting) of all SARS-CoV-2 positive cases can be classified as severe or necessitating intensive care unit (ICU) admission.
In the early stages of the outbreak unfolding, several retrospective case studies and cases series carried out in China reported that those who died were more likely to be male, and more likely to have underlying comorbidities. Prevalence studies conducted in the US and Italy show similar trends in the distribution of comorbidities among SARS-CoV-2 severe cases; adding obesity (BMI>30) to the list of factors potentially associated with disease severity. However, the relative importance of different underlying health conditions remains unclear owing to inadequate adjustment for important confounding factors such as age, sex, and smoking status.
We propose a cohort study to evaluate predictors, clinical evolution and excess of mortality of SARS-CoV-2 in hospitalised patients, with two main workstreams- the first looking at all patients admitted to SGHFT and the second looking at patients admitted to ITU with respiratory failure.
Detailed description
The majority of published reports on early clinical descriptions of COVID-19 have emerged from Hubei province in China, and although these provide valuable information, the lack of standardised mortality and morbidity ratios hinders comparison of outcome experience across populations. Also, most of the data available originate from descriptive cases or series that do not account for confounding effect; so, as yet there are no specific data on how the risks associated with underlying comorbidities might vary in different population groups or settings.
Recognition of risk factors for morbidity and mortality is important to determine prevention strategies as well as to target high-risk populations for potential therapeutics. So, in this study we aim to develop a predictive statistical model to identify baseline predictors of mortality including underlying health conditions and biomarker levels at admission to improve the understanding of the clinical evolution of patients with severe COVID-19.
An approximative 20-30% of regular admissions in the ICU are with respiratory failure. A considerably higher number is expected in the current climate. Government policies have aimed to flatten the epidemic curve to ease the pressure on the NHS to ensure as many people as possible have access to the appropriate level of intensive care. However, even in the best-case scenario, the number of people requiring level 3 care in ICU may be ten times the current capacity.
The excess of mortality due to SARS-CoV-2 in this population hasn't been fully assessed. It is unknown if the evolution of this disease shares common characteristics with other bacterial or viral infections. This information is invaluable in order to shape diagnostic protocols, prevent complications and design therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workstream 1 | – | Other: SARS-CoV2 InfectionAdult patients admitted to SGHFT (St. Georges Hospital Foundation Trust) with or without laboratory confirmed SARS- CoV-2. |
| Workstream 2 | – | Other: SARS-CoV2 InfectionAdult patients admitted to to SGHFT (St. Georges Hospital Foundation Trust) ITU with respiratory failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for workstream 1, will comprise adults (>=18years) with or without laboratory confirmed SARS-CoV-2 infection admitted to SGHFT between 01 December 2019 and 30 April 2022. The study population for workstream 2, will comprise adults (>=18years) with respiratory failure (all causes) admitted to intensive care between 01 December 2019 and 30 April 2022.
Key inclusion criteria (7 listed)
- Adults (aged ≥18 years).
- Patients attending SGHFT.
- Adult (aged ≥18 years) patients admitted to ICU areas during the period of study
- Presence of acute respiratory failure: this is defined by meeting all the following criteria:
Key exclusion criteria (2 listed)
- Children and adolescents (< 18 years). Workstream 2
- Respiratory symptoms explained by cardiac failure or fluid overload alone
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 |
|---|---|---|
| SARS-CoV2 InfectionLaboratory confirmed SARS-CoV2 | Other | Workstream 1, Workstream 2 |
Primary outcome
SARS-CoV-2 hospital mortality
Time frame: 6 months from admission
To assess mortality in SARS-CoV-2 patients admitted to SGHFT wards.
SARS-CoV-2 mortality in critical care unit
Time frame: 6 months from admission
To assess the risk of death attributable to COVID-19, in comparison with non-Covid-19, in patients admitted to critical care with respiratory failure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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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.
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 and SARS-CoV 2, run by St George's University Hospitals NHS Foundation Trust 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 7 inclusion and 2 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 22 Oct 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?
Contact Timothy D Planche, Dr. (02087252683, tim.planche@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 hospital mortality (time frame: 6 months from admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020; AzTrials last refreshed its copy on 29 Oct 2026.