Condition category
Respiratory
Date applied
09/09/2020
Date assigned
22/10/2020
Last edited
05/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The new coronavirus disease, SARS-CoV-2, is a rapidly emerging global health threat. Health care systems have been on the brink of collapse across the world, reflecting the absence of effective treatment for severe coronavirus 19 disease (COVID-19). Early data show marked differences in the extent to which patients are affected by the virus, with 80% showing little or no symptoms, while others have severe disease, with a fatality rate of 1-2%, usually as the result of progressive COVID pneumonia. The disease can affect people very differently and this study wishes to identify sub-groups of patients to allow targeting of treatment for maximum impact and minimum risk, ideally using biological signatures, or ‘endotypes’. ASTERIX is an observational study that will collect surplus samples (blood, respiratory secretions and urine) and data on COVID patients admitted to hospital. This study aims to identify and define these sub-groups of patients, and demonstrate the link between endotype and severity of disease and likely response to treatment.

Who can participate?
All patients 8 years and over admitted to hospital with suspected COVID-19 are eligible to participate.

What does the study involve?
There are no specific trial activities. Patients will be asked to give consent verbally to have their clinical data collected, and for any surplus samples of blood, respiratory secretions, and urine collected during admission and up to 1 year afterward to be available for research purposes.

What are the possible benefits and risks of participating?
There is no direct benefit to the patient, however, the data collected may provide information that can improve future care for COVID-19 patients.

Where is the study run from?
The study is co-ordinated by the CRUK Clinical Trials Unit (UK), and is sponsored by NHS Greater Glasgow and Clyde (UK).

When is the study starting and how long is it expected to run for?
The study will run from April 2020 to April 2021 (updated 05/01/2021, previously: January 2021). Data have been collected retrospectively from January 2020, and patients will continue to be recruited until January 2021.

Who is funding the study?
Chief Scientist Office, Scottish Government (UK) and the National Institute for Health Research (UK)

Who is the main contact?
1. Professor Kevin Blyth (CI)
Kevin.Blyth@glasgow.ac.uk
2. Mrs Carol Evans
carol.evans@glasgow.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Carol Evans

ORCID ID

Contact details

Clinical Trials Unit
Level 0
Beatson West of Scotland Cancer Centre
Glasgow
G12 0YN
United Kingdom
+44 (0)141 301 7189
carol.evans@glasgow.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 46231, IRAS 283151

Study information

Scientific title

Adaptive Stratification of COVID-19 to facilitate Endotype-directed Intervention Studies (ASTERIX)

Acronym

ASTERIX

Study hypothesis

That it is possible to identify discrete sub-groups of patients (endotypes), based on a range of demographic, clinical, and laboratory biomarkers, that predict:
1. Progression though different stages of disease severity
2. The likelihood of response to therapies

Ethics approval

Approved 21/05/2020, West of Scotland REC 5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 20/WS/0077

Study design

Observational cohort trial

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

The study aims to achieve the following:
1. Recruit between 600 and 1200 participants with appropriate approvals
2. To acquire and record the necessary biological and outcome data using direct electronic medical record (EMR) capture and a bespoke data collection tool embedded in COVID19 clinical care (the NHS GGC COVID19 assessment tool).
3. Provide a structured biobanking infrastructure, with surplus biological samples linked to clinical data, and a resource for observational, translational and interventional studies
4. Develop different statistical models based on the data collected for progression to three adverse outcomes: 4.1. COVID-19 Pneumonia
4.2. Development of respiratory failure, sufficient to prompt escalation to at least Step 6 of the World Health Organisation (WHO) 10-point ordinal scale
4.3. Death from any cause
These models will generate critical information needed to design high impact clinical trials, including the most suitable mechanism(s) of action at different phases of the illness and the event rate at each timepoint based on current standard of care.

Data Collection
Data will be extracted from clinical record into the NHS GG&C Safe Haven. Automated processes will capture most data fields. However, daily clinical data (e.g. oxygen requirement, clinical observations, vital status) will be collected by ward staff, using a bespoke bedside data collection tool embedded in clinical care (the NHSGGC COVID19 assessment tool). This information will constitute the routine clinical record therefore no study visits will be required.

Biological Sample Processing and Banking
No study specific blood samples will be taken. Surplus blood (+/- any surplus respiratory secretions and urine) will be collected from the laboratories at Baseline (Day 0) and where possible in a series of follow-up windows that span the course of admission (up to 14 days). If blood samples are sent from any hospital follow-up visit within 1-year these will also be banked. Immediate blood sample processing will allow storage of plasma, serum and Peripheral Blood Mononuclear Cells (PBMCs) for COVID research.

Statistical Analyses
The target sample size of 600-1200 will yield 400-800 confirmed cases. These numbers will be sufficient for the primary statistical analyses (generation of reliable models for each progression event). The content of these models will include the routinely available clinical data, the result of blood test performed in clinical practice and the results of a limited number of additional tests performed on the surplus blood samples. These additional assays will include measurements implicated in COVID-19 series, but not routinely measured by clinical teams (e.g. Troponin, D-Dimer). Multivariable predictive models (endotypes) will be generated for each progression event using logistic regression, and the performance of any developed models will be validated in an independent data set.

Intervention type

Other

Phase

Drug names

Primary outcome measure

To acquire and record the necessary biological and outcome data by extracting electronic medical records held by the NHS trust Safe Haven, collected at various timepoints by automated processes. Daily clinical data (e.g. oxygen requirement, clinical observations, vital status) will also be collected by ward staff using a bedside clinical collection tool embedded in clinical care daily clinical data (the NHSGGC COVID19 assessment tool). Biological materials (e.g. blood, respiratory secretions, urine) for potential translational research will be surplus material from that routinely collected during the hospital admission, and also any follow-up hospital visits within 1 year.

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/04/2020

Overall trial end date

30/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Admitted to hospital with suspected COVID-19

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 600; UK Sample Size: 600

Participant exclusion criteria

1. Aged <8 years (lower age limit aligns with current NHSGGC Biorepository REC approval for storage and use of surplus tissue)

Recruitment start date

01/01/2020

Recruitment end date

30/01/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
J B Russell House Gartnavel Royal Hospital 1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

Reay House
17 Old Edinburgh Road
Inverness
G12 0XH
United Kingdom
+44 (0)14713144001
joanne.mcgarry@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nhsggc.org.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office, Scottish Government Health and Social Care Directorate

Alternative name(s)

The Chief Scientist Office, CSO

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal estimated December 2021.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from NHSGGC safe haven (safehaven@ggc.scot.nhs.uk). The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/01/2021: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/01/2021 to 30/01/2021. 2. The overall end date was changed from 01/01/2021 to 30/04/2021. 3. The plain English summary was updated to reflect these changes. 05/11/2020: Uploaded protocol (not peer reviewed) Version 1, 11 May 2020. 09/09/2020: Trial’s existence confirmed by the National Institute for Health Research (NIHR).