Participant Information

Participant Information Sheet

Convalescent inflammatory conditions: a metabolomic analysis

Thank you for considering participating in our research project. This information sheet provides some information to help you decide if you would like to take part. Please take time to read this carefully and discuss with friends, family, your GP, or the research team as you wish. If there is anything here that is unclear, or if you would like more information on anything, feel free to contact us and ask.

What is the purpose of this research?

Millions of people throughout the UK and the world have suffered from COVID-19 infection. It is thought that around a quarter of these people do not get better within 6 weeks but continue to suffer symptoms. These can be severe, and affect their breathing, heart, thinking, or cause other problems. Some people still cannot work months after first getting the virus. This condition has come to be known as long Covid.

Some researchers have suggested this may be similar to symptoms some people seem to get after other virus infections, diseases such as rheumatoid arthritis, which are known as ‘inflammatory conditions’, or problems such as myalgic encephalitis, which is sometimes also called chronic fatigue syndrome.

This study aims to compare patterns of small molecules in the blood and urine of people suffering from all these conditions.

We hope this will help researchers tell the difference between them and hopefully better understand what causes them and how we might improve, or develop new, treatments.

Who can take part?

Anyone who is aged 18 or older may be able to take part if they have previously had any positive PCR, rapid antigen, or antibody tests for COVID-19.

We need people EITHER who do not have symptoms now and who got better in 6 weeks or less OR who have been diagnosed with long COVID by a doctor and are still having symptoms after at least 6 weeks. Importantly, you must not have been admitted to hospital for treatment of your COVID-19 infection.

You cannot take part if you had a positive COVID-19 test less than 6 weeks ago or live outside the Thames Valley Region and are not prepared to travel to the University of Oxford.

You also cannot take part if you are pregnant or breast feeding, have a known blood borne viral infection such as human immunodeficiency virus (HIV) or hepatitis B and C, or suffer from needle phobia.

You must be able to speak English so we can ensure that you have fully understood what the research involves and give consent.

What will the study involve?

1. If you get in touch with us to learn more we will first organize a phone call with a member of our research team. We will answer any questions you have.

2. If you decide to take part we will ask you to sign an online consent form. We can stay on the phone while you do this to help if that is easiest for you. We will email you a copy of this form for your records.

3. Next we will ask you to complete a questionnaire. This will either be available for you to complete online or we will send a version to you in the post with a pre-paid envelope for you to return it. You can complete this over as many sittings as you would like and it will take about 30 minutes to answer in total.

This will include some basic details including age, gender, occupation, any medical problems, current medications, information about your symptoms, and any investigation and treatments you have had. You do not have to answer any questions you would prefer not to.

4. Then we will either arrange for a researcher to visit you at home if you live within the Thames Valley region or for you to visit the research site at the Department of Pharmacology, Mansfield Road, Oxford, OX1 3QT. 

At this time the researcher will ask you the time of your last meal and will take a single blood sample from your arm (4 small tubes which is the equivalent of up to 24ml or approximately 5 teaspoons of blood). The procedure for each visit will be exactly the same as for any samples obtained when you go to a hospital or your GP surgery and will be performed by a member of the research team proficient in phlebotomy skills.

The visit should last approximately 15 minutes in total.

5. We will also ask you to bring a urine sample for us. We will send a specimen bottle to you in the post and will ask you to take a sample from the first urine you pass in the morning of your visit.

6. If you suffer from long COVID we will ask for your permission to contact you after 9 months. If you agree, at this point we will ask you to complete one further questionnaire (similar to the first one) to update any changes in your information or symptoms. We will also arrange a further visit at home or in Oxford at which we will collect one further blood and urine sample with your consent in exactly the same way as the first visit.

The sample will then be analysed in the laboratory. This will involve a process which destroys genetic (the coding information in cells that makes it specific to you) and cellular material. This means no-one can now identify that the samples came from you.  

The remaining liquid will be stored at the Department of Pharmacology for up to 25 years. No data will be stored with the samples that mean they could be identified as having come from you.

Storage of all our samples is closely governed and monitored by University of Oxford regulations. We will also ask for your consent at the beginning of the study to be able to use your anonymized samples for future studies.

We will ask for your contact details which will be kept until the sample has been analysed in case we need to contact you for any reason.

Do I have to participate?

No, it is up to you to decide if you want to participate.

As discussed, we are very happy to answer any questions you have after reading this sheet either by email or on the phone.

You will be free to withdraw from the study at any time, without giving any reason if you do not wish to do so. Deciding not to take part or withdrawing from the study will not affect your clinical care, academic, or professional record in any way. You can do this by e-mailing metabolomics@pharm.ox.ac.uk.

Once your sample has been analysed and the information combined with other participants, it will not be possible to withdraw.

Are there any risks to taking part in this study?

Taking a blood sample is generally very safe but can be associated with a small amount of discomfort. Occasionally a bruise may form around the site from which blood was taken, which should disappear very quickly and have no long-term consequences.

Occasionally it can take more than one attempt to obtain a blood sample: in this situation we would try up to 2 further times (with your permission) before not proceeding further. Occasionally people can feel a little faint when blood samples are taken: we will ensure there is somewhere for you to lie down if this should occur.

The study is investigating changes in the blood which may happen in people with new COVID-19, long COVID, rheumatoid arthritis, and chronic fatigue syndrome/myalgic encephalitis. You have been recruited because you are suffering from one of these disorders. As the aim of the study is detect abnormalities relating to these conditions it is possible we may detect that your sample is more likely to have these changes.

We do not know what this information will mean in terms of investigation and treatment therefore we will not disclose this specifically to you. We will feed back the overall results of our study to all participants. 

Are there any benefits to participating in this study?

There are no direct benefits to participants in this study and unfortunately we are unable to offer any renumeration, but we hope that the results will help the care and treatment of other people in future.

What happens to the data collected? Is it confidential?

The information and samples you provide are identified only by a code number, which is only used in the study. We will collect your contact details separately so that we could contact you if needed, as described above. We will keep these details secure, and will destroy them completely as soon as analysis is completed. They will not be used for any other purposes than this study.

Your anonymized samples and data will be kept for use in future studies with your consent as described above. A copy of the consent form(s), which contain your name and electronic signature, will be stored in a secure location, and will be kept separate from the rest of the information we collect.

We will record the information you provide on a secure database, and it will be handled in accordance with the Data Protection Act 1998. All information you provide will be handled strictly confidentially.  Responsible members of the University of Oxford may be given access to data for monitoring and/or audit of the study to ensure we are complying with regulations.

Who has reviewed this study?

All research studies are checked by an ethics committee to ensure research is conducted safely and to the best possible standards. This research project has been reviewed by and received HRA and HCRW ethics clearance from the London - Camden & Kings Cross Research Ethics Committee (REC reference: 21/PR/0838).

Who is organising and funding the research?

The study is led by Dr Emma Ladds, GP and clinical researcher, Daniel Anthony, Professor of Pharmacology, and Isobel Dunstan, DPhil in Pharmacology.

It is funded by money from the University of Oxford, which is specifically for investigating COVID-19 infection.

What will happen to the results of the research?

This research project will be published in a journal, a PhD thesis, and/or presented at a conference. All participants will be invited to attend a webinar presentation of the results where they will be able to ask any questions about the findings.

What if something goes wrong?

If you have a concern about any aspect of this project, please speak to the relevant researcher (01865 281135 or metabolomics@pharm.ox.ac.uk) who will do their best to answer your query. The researcher should acknowledge your concern within 10 working days and give you an indication of how they intend to deal with it.

If you remain unhappy or wish to make a formal complaint, please contact the chair of the Research Ethics Committee at the University of Oxford (Chair, Medical Sciences Inter-Divisional Research Ethics Committee; Email: ethics@medsci.ox.ac.uk; Address: Research Services, University of Oxford, Wellington Square, Oxford OX1 2JD).  The chair will seek to resolve the matter in a reasonably expeditious manner.

What if I have further questions or would like to take part?

Please contact the research team at e.ladds@nhs.net, who will happily answer any further questions you may have and provide you with the next information about how to take part.