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CORVIS study: Participant Information Sheet

 

Contents

This study will take place at PRC: Newcastle, part of The Newcastle upon Tyne Hospitals NHS Foundation Trust. Please get in touch if you would like to take part.

Study title: COmmunity patients at Risk of Viral Infections including SARS-CoV-2 (CORVIS)

IRAS ID: 290709
Sponsor: Thirty Respiratory Limited

Summary

We are inviting people with Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis to join the CORVIS study. The main objective of this study is to assess whether a novel nebulised inhaled treatment can be successfully used by patients in a home setting to treat episodes of worsening respiratory symptoms. The study involves one study visit at the start and regular calls with the study team during/ and or up to a maximum of 57 weeks. The participants will receive one test dose of the study drug at the study visit. Those participants who experience worsening of their respiratory symptoms (exacerbation) over the next 12 months, will also receive a 7-day course of the study treatment to self-administer at home.

In this research study we will use information from you, your medical records and your GP. We will treat this information in utmost confidence and only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study.

Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. At the end of the study we will save some of the data in case we need to check it. We will make sure no-one can work out who you are from the reports we write.

Please read this Information Sheet if you would like to know more about the study, including aims, risks and benefits of taking part.

What is the purpose of the study?

The global COVID-19 pandemic caused by the SARS-CoV-2 virus is of major concern for those with underlying lung conditions. There is a need for new treatments to help prevent progression of infection symptoms at an early stage.

In this study, we are investigating a novel drug, RESP301. It is a liquid which is inhaled using a handheld nebuliser. When inhaled, RESP301 produces Nitric Oxide, which is also naturally produced in the human body and is a key component of our defence against microbial infection in the lung. In a laboratory setting, RESP301 has been shown to be highly effective against many respiratory viruses, including SARS-CoV-2 and influenza. The drug is currently being used as treatment for hospitalised COVID-19 patients in an ongoing randomised controlled clinical trial.

We intend to recruit 150 adult patients with COPD or bronchiectasis from primary and secondary care sites in the UK. The aim of the study is to assess whether patients are able and willing to use nebuliser RESP301 treatment in their home setting following onset of worsening respiratory symptoms which may be linked to a lung infection. We will also collect data on drug safety and tolerability. Preliminary data will be collected to assess whether RESP301 could help slow the progression of symptoms or help faster recovery.

What would taking part involve?

The study involves one study visit at a research site. This visit can last up to 3 hours. A test dose of the study drug, RESP301, will be administered at this visit and only those participants who tolerate the test dose will continue in the study. These participants will be trained on how to use the nebuliser and the study drug. However, participants will not receive any further study treatment unless they start experiencing worsening of their respiratory symptoms (exacerbation) over the next 12 moths. If this happens, the participants should contact the study team as soon as possible. After confirming that the participant is suitable for receiving study treatment, the team will arrange a home delivery of the drug and a nebuliser to the participant. The participants would then take the study drug at home for 7 days. Further details about the study visit, procedures and requirements are provided below in section “What will happen to me if I take part?”.

Can I take part?

We intend to recruit 150 people to the study. To be eligible to take part, you should have a diagnosis of COPD or bronchiectasis. You will not be eligible if you:

  • Have severe asthma or history of severe bronchospasm
  • History of methaemoglobinaemia
  • Are not able to perform spirometry or use a nebuliser
  • Live alone or without any other adults in the household
  • Are a female capable of becoming pregnant

There are some medical conditions and medications that you take which may make you unsuitable for the study. The study team will conduct a careful assessment during the screening visit to check whether you are eligible to proceed.

Do I have to take part?

Participation in this study is entirely voluntary. It is up to you to decide whether you would like to take part or not. If you decide not to take part, this will not affect the standard of care you receive from the NHS in any way, now or in the future.

What will happen to me if I take part?

If you are interested in taking part, please contact the study team using the contact details at the end of this Information Sheet. If you are potentially suitable for the study, the team will schedule you for a Screening Visit appointment.

DURING THE SCREENING VISIT

The following procedures will take place:

Informed consent

Before any study procedures take place, the team will discuss the study with you and you will have an opportunity to ask any questions you might have. If you are happy to proceed in the study, you will be asked to sign an Informed Consent Form.

Confirming eligibility

The study team will review your medical history and medications list, and conduct some physical assessments (blood pressure, heart rate, respiratory rate, body temperature) to confirm that you are eligible to proceed in the study.

They will also perform a simple fingertip test to measure the level of a specific type of haemoglobin called methaemoglobin in your blood. This test is completely non-invasive and will not require any blood to be taken. Unlike haemoglobin, methaemoglobin is not able to carry oxygen and if your level of methaemoglobin is high, the study treatment might cause you some problems.

Spirometry

The study team may also assess your lung function using spirometry. However, this will only be required if you are amongst the first 70 participants or if you have not had a lung function test in the last year.

The Clinical COPD Questionnaire

You will be asked to complete a brief 10-item questionnaire about your COPD symptoms.

Test dose of RESP301

During the Screening Visit at least the first 70 participants will receive a test dose of the study drug, RESP301. This is inhaled via a nebuliser and the study team will monitor the participants carefully during the dose administration. To assess how they response to the dose, the study team will monitor any physical reactions (such as cough) and will measure methaemoglobin level again with the fingertip test during and after the dose. The participants will also be asked to complete a lung function test after the test dose.

If the test dose causes any problems or reactions which the study team feels might put the participant at risk when taking the study treatment, the participant would not proceed further in the study. However, the study team would contact them a week later to make sure they have not experienced any further problems.

If the test dose does not cause any problems, the participant will be eligible to proceed in the study.

Instructions

If you continue to proceed in the study after the test dose, or are recruited after the first 70 participants and do not require a test dose assessment, the study team will give you instructions on how to use the nebuliser and the study drug. However, at this stage you will not need to take any further study treatment. You will be given a list of symptoms (see below) and should contact the study team as soon as possible, if you experience any of these symptoms in the next 12 months.

AFTER THE SCREENING VISIT

After your Screening Visit, you should continue to use your usual COPD and bronchiectasis medications and any other treatments prescribed to you by your doctor. Please also follow any usual advice from your doctor or COPD nurse regarding an exacerbation, e.g. starting your rescue medication if prescribed. If you start experiencing any of the following symptoms in the 12 months following your Screening Visit, you should contact the study team as soon as possible (within 72 hours):

  • fever
  • feeling weak or unwell
  • increased cough
  • increased wheeze
  • increased sputum volume
  • yellow or green sputum

The study team will then discuss your symptoms and ask about your current medications and any changes to your medical history. If the study team considers you to be suitable to receive study treatment, they will arrange a home delivery of the study drug and a nebuliser to you. Please read the STUDY TREATMENT section below for more information about what taking the treatment at home involves.

If you are not experiencing any of the above symptoms, there is nothing you need to do. However, the study team will call you monthly during the 12 months after your Screening Visit to check that you are happy to continue in the study and remind you to contact them if any of the symptoms emerge.

STUDY TREATMENT

Taking the study treatment would involve preparing the drug dose by mixing two solutions and inhaling with a nebuliser three times a day, leaving at least 4 hours between the doses. The inhalation should start within 5 minutes of mixing the solutions and the inhalation process should be completed within 20 minutes of starting inhalation. You should continue the treatment for 7 days. During these 7 days, you will be asked to complete a daily study diary to record the doses you have taken, body temperature and a score about how you feel. The study team will call you every day during the 7 days to go through the study diary information with you. You can also discuss any side effects or problems you may have with the study team during these calls or contact the study team at any point if you have any questions. Currently, information about possible side effects of the study treatment is only available from a small number of clinical trial participants with COVID-19. The only side effect reported so far has been citrus taste of the inhaled mist.

On the first and last day of treatment, you should also complete the Clinical COPD Questionnaire.

AFTER THE STUDY TREATMENT

The study team will contact you approximately 14 and 28 days after you complete the study treatment for a brief phone call. If your symptoms have not recovered by the end of the treatment period, you do not need to continue the study treatment but will be asked to continue completing the study diary for up to another 14 days.

What happens if my symptoms get worse?

If your symptoms get worse at any point during the study, please contact your GP. We will give you a card that you can carry to let other healthcare professionals know that you are taking part in this study. Please also contact us (email: nuth.researchstudies@nhs.net, telephone: 0191 282 3981) as soon as possible if your symptoms get worse. It is important that we are informed if you are admitted to hospital at any point during the study, even when you are not taking the study drug. Please let someone close to you know that you are taking part in the study, so that if you are admitted to hospital, they can use the details on the card to let us know.

What are the possible benefits of taking part?

We do not know if the study drug, RESP301, will have benefits. We hope the treatment will help you but even if not, we believe the study will help answer important questions and thereby help patients in the future.

What are the possible disadvantages and risks of taking part?

With any medicine, there is a risk of side effects. All participants will receive a test dose of RESP301 under the supervision of the study team and will be monitored for up to one hour following the test dose. If any concerns arise, the participant will not be allowed to continue in the study. If you do proceed in the study and receive further study treatment to self-administer at home, the study team will contact you every day (while taking the study medication) and you will be able to discuss any side effects with them. If any problems emerge, the study team would decide whether it is safe for you to continue in the study.

What if something goes wrong?

If you have any questions about this study, please contact the study team (see the end of this Information Sheet for contact details).

If you have a complaint which cannot be resolved with the study team, please contact NHS England at: england.contactus@nhs.net or by telephone on 0300 311 22 33. You can also send a letter by post to: NHS England, PO Box 16738, Redditch, B97 9PT.

If you are making a complaint, please state: ‘For the attention of the complaints team’ in the subject line.

The study Sponsor, Thirty Respiratory Limited, has appropriate insurance in place in the unlikely event that you suffer any harm as a result of your participation in this study. NHS indemnity operates in respect of the clinical treatment with which you are provided.

What will happen if I don't want to carry on with the study?

You can withdraw your consent to take part at any time without giving a reason. Information collected up to that point will still be used. If you wish to withdraw from the study, please contact the study team using the contact details at the end of this Information Sheet. The decision to withdraw will not affect the standard of care you receive from the NHS in any way, now or in the future.

Expenses and Payments

You will be reimbursed £20 worth of gift vouchers for attending the study visit and the same again if you receive study treatment and return the study diaries. You will receive this at the end of the Screening Visit. We will also compensate any reasonable travel costs the Screening Visit (up to £50).

How will my information be used?

We, the study Sponsor (Thirty Respiratory Limited), will need to use information from your medical records and your GP for this research project.

This information will include your name, contact details, medical history and medications. The study team at the research site will be responsible for securely holding this information at the site. The Sponsor will not hold any documents that contain your personal identifiers such as your name, address or date of birth. However, the Sponsor would have the right to access and view all the information about you that is held by the study team. We will use this information to do the research or to check your records to make sure that the research is being done properly.

In addition, the study team would need to share your name, address and contact details with companies that are delivering the study drug and nebuliser to you. These companies are licensed to deliver drugs and would only hold your details for the purposes of delivering the treatment to you. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

We will keep all information about you safe and secure.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no one can work out that you took part in the study.

What are my choices about how my information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. If you choose to stop taking part in the study, we may still continue collecting information about your health from your hospital or your GP until the end of the study. If you do not want this to happen, please let the study team know.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

Where can I find out more about how my information is used?

You can find out more about how we use your information

What will happen to the results of this study?

When the study has finished, your study team will be informed of the findings and will be encouraged to share a summary on their website and/or newsletters. In addition, the results will be reported on the Sponsor’s website, on the EU Clinical Trials Register website, in medical journals and presented at scientific conferences. All results published will be anonymised, which means that you will not be identified from them.

Who is organising and funding this study?

This study is funded by the study Sponsor, Thirty Respiratory Limited. The study is organised by the Sponsor, in collaboration with the National Institute for Health Research (NIHR) Patient Recruitment Centre: Newcastle, and the Chief Investigator, Professor Anthony De-Soyza (Newcastle Hospitals).

Who has reviewed this study?

All research in the NHS is looked at by an independent group of people called a Research Ethics Committee (REC). The REC is there to protect your safety, rights, wellbeing and dignity. This study has been ethically reviewed and was approved by the Oxford Research Ethics Committee. This study has also received approval from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA regulates the use of all medicines in the UK.

What if relevant new information becomes available?

Sometimes during the course of a study, new information becomes available about the study treatment. In this case, the study team will tell you about it and discuss with you whether you want to continue in the study or not. If you decide to continue you may be asked to sign an updated consent form.

Thank you for taking the time to read this Information Sheet.