Condition category
Infections and Infestations
Date applied
05/10/2020
Date assigned
05/11/2020
Last edited
05/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
The pandemic caused by SARS-CoV-2 has already led to over 1 million deaths worldwide. There is an urgent need to understand more about the biology of this disease. The aim of this study is to collect specimens from patients who have been confirmed to have active or convalescent (recovering from) SARS-CoV-2 infection, and a corresponding healthy control group, to assess the immunological response to the infection in patients with a range of clinical manifestations (symptoms) of the disease.

Who can participate?
Patients and members of the public who have been infected with SARS-CoV-2, whether or not they developed COVID-19 symptoms, and uninfected volunteers

What does the study involve?
The study involves donating blood samples, nasal swabs and/or samples of saliva. The volume and frequency of sampling depends on the specific sub-study a participant is involved in.

What are the possible benefits and risks of participating?
A number of participants are recruited at the time of donating a routine clinical sample, in which case the study doesn't present any additional risks. For those who donate a blood sample purely for research purposes the process carries the potential risk of a small bruise or mild soreness at the puncture site and the very rare possibility of infection at the puncture site.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
April 2020 to June 2025

Who is funding the study?
1. Medical Research Council (UK)
2. Department of Health and Social Care (UK)

Who is the main contact?
Unfortunately, this study is not recruiting public volunteers at this time. This is because researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Moss

ORCID ID

http://orcid.org/0000-0002-6895-1967

Contact details

University of Birmingham
Edgbaston
Birmingham
B15 2TA
United Kingdom

Type

Scientific

Additional contact

Dr Rachel Bruton

ORCID ID

Contact details

College of Medical and Dental Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 46588, IRAS 282164, RG_20-038 COVID-19

Study information

Scientific title

Coronavirus Immunological Analysis (CIA)

Acronym

Study hypothesis

The aim of this study is to collect specimens from patients who have been confirmed to have active or convalescent SARS-CoV-2 infection, and a corresponding healthy control group, to assess the immunological response to the infection in patients with a range of clinical manifestations of the disease.

Ethics approval

Approved 01/05/2020, North West - Preston Research Ethics Committee (Barlow House 3rd Floor 4 Minshull Street Manchester, M1 3DZ, UK; +44 (0)207 104 8056; preston.rec@hra.nhs.uk), REC ref: 20/NW/0240

Study design

Observational; Design type: Clinical Laboratory Study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

The researchers are taking blood samples by the process of phlebotomy and taking nasal swabs using the usual nasal swab kits and saliva collection using commercially available basic saliva collection kits.

Collection 1. 'Waste' samples from hospital diagnostic laboratories
Here the researchers will:
1. Identify patients who have been tested for SARS-CoV-2 infection status
2. Localise matched samples that are >24 hours old and on which all diagnostic tests have been performed
3. These samples will be used for immediate analysis or storage for later investigations
4. Samples will be taken daily on the identified patient so that a 'prospective' analysis can be undertaken

Collection 2. Samples from patients, and controls, in hospital under appropriate consent
Here the researchers will:
1. Identify patients who have been tested for SARS-CoV-2 infection and are in hospital
2. The managing clinical team will assess if the patient is well enough to consider consent and will then approach the patient
3. The patient will be offered a Patient Information Sheet
4. Consent and sample collection may then commence

Collection 3. Samples from patients, and controls, who are at home
Here the researchers will:
1. Identify patients who have been tested for SARS-CoV-2 infection and are not in hospital
2. Send a letter to the patient asking them to contact us if they are interested in giving samples
3. Send a Patient Information Sheet to responders
4. Consent and sample collection may occur in hospital or the community

Collection 4. Samples from healthy donors
Here the researchers will:
1. Invite volunteers to take part in the study
2. Give a Patient Information Sheet to responders
3. Consent and sample collection will occur in University or hospital facility

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Presence of immune response to SARS-CoV-2 measured using enzyme-linked immunosorbent assay (ELISA) and direct solid-state protein-binding assays such as Meso Scale Discovery (MSD) at various timepoints depending on the patient
2. Immunological and biological response to SARS-CoV-2 infection and its correlation with clinical outcome, measured using flow cytometry, proteomic analyses and functional studies at various timepoints depending on the patient

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/04/2020

Overall trial end date

05/06/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients and volunteers who have been tested for SARS-CoV-2 infection (both positive and negative for infection) and a matched control group

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 600; UK Sample Size: 600

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/05/2020

Recruitment end date

05/05/2025

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital Birmingham
Mindelsohn Way Edgbaston
Birmingham
B15 2GW
United Kingdom

Trial participating centre

Heartlands Hospital Bordesley Green East
Bordesley Green
Birmingham
B9 5SS
United Kingdom

Trial participating centre

Good Hope Hospital
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Research Support Group
Aston Webb Block B
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 8011
researchgovernance@contacts.bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

Department of Health and Social Care (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal within 24 months of recruitment start.

IPD sharing statement
The raw datasets will not be available, but the analysed data will be made available in peer-reviewed journals.

Intention to publish date

15/05/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/10/2020: Trial's existence confirmed by the NIHR.