COVID19 Clinical Predictors and Outcome

NCT04416347 | Unknown

• 1 other identifier: 2020.0115
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID; SARS-CoV 2

Outcome Measures

Primary Outcomes (2)

• SARS-CoV-2 hospital mortality

  To assess mortality in SARS-CoV-2 patients admitted to SGHFT wards.

  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.

  6 months from admission

Study Arms (2)

Workstream 1

Adult patients admitted to SGHFT (St. Georges Hospital Foundation Trust) with or without laboratory confirmed SARS- CoV-2.

Other: SARS-CoV2 Infection

Workstream 2

Adult patients admitted to to SGHFT (St. Georges Hospital Foundation Trust) ITU with respiratory failure.

Other: SARS-CoV2 Infection

Interventions

SARS-CoV2 Infection OTHER

Laboratory confirmed SARS-CoV2

Workstream 1; Workstream 2

Eligibility Criteria

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

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.

You may qualify if:

• Adults (aged ≥18 years).
• Patients attending SGHFT.

You may not qualify if:

• Children and adolescents (\< 18 years). Workstream 2
• 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
• Respiratory symptoms explained by cardiac failure or fluid overload alone

Sponsors & Collaborators

• St George's University Hospitals NHS Foundation Trust: lead

Study Sites (1)

St. George's University Hospitals Foundation Trust.

London, SW17 0RE, United Kingdom

RECRUITING

Central Study Contacts

Timothy D Planche, Dr.

CONTACT

02087252683; tim.planche@nhs.net

Study Design

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

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: June 4, 2020
• Study Start: June 15, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)