Analysis of the immunological response to coronavirus infection
| ISRCTN | ISRCTN63911163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63911163 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 282164 |
| Protocol serial number | CPMS 46588, IRAS 282164, RG_20-038 COVID-19 |
| Sponsor | University of Birmingham |
| Funders | Medical Research Council, Department of Health and Social Care (UK) |
- Submission date
- 05/10/2020
- Registration date
- 05/11/2020
- Last edited
- 05/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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.
Contact information
Scientific
University of Birmingham
Edgbaston
Birmingham
B15 2TA
United Kingdom
 ORCID ID |
0000-0002-6895-1967 |
|---|
Scientific
College of Medical and Dental Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational; Design type: Clinical Laboratory Study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Coronavirus Immunological Analysis (CIA) |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 05/06/2025 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 600 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 15/05/2020 |
| Date of final enrolment | 05/05/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Edgbaston
Birmingham
B15 2GW
United Kingdom
Birmingham
B9 5SS
United Kingdom
Sutton Coldfield
B75 7RR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The raw datasets will not be available, but the analysed data will be made available in peer-reviewed journals. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/10/2020: Trial's existence confirmed by the NIHR.
