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Ringmead Medical Practice

Postal Address - Ringmead Medical Practice, Birch Hill Medical Centre, Leppington, Bracknell, RG12 7WW

Sites - Birch Hill Medical Centre, Great Hollands Health Centre and Crowthorne Surgery

PCN - The Health Triangle

Telephone: 01344 20 80 60

AZD7442 for Treatment of COVID‐19 in Outpatient Adults (TACKLE)

Tuesday, 23 March 2021

Ringmead Medical Practice is taking part in the “TACKLE” research study where Covid-19 treatment is tested in the Community.

Similar monoclonal antibody treatment is already available in the NHS however via intravenous route only for hospitalised patients who have severe disease.

1. What is the purpose of this trial?

The fight against COVID-19 is still ongoing and we need your help. We want to evaluate how an investigational medication, which is a combination of two monoclonal antibodies can treat adults with mild to moderate symptoms of COVID-19 in order to prevent them from suffering with severe COVID-19. This study is taking place in approximately 14 countries

2.What is this study about?

This is A Phase III Randomized, Double‐blind, Placebo‐Controlled, Multicentre Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID‐19 in Non‐ Hospitalized Adults (TACKLE).

There is an urgent need to quickly evaluate treatments that might prevent the disease from worsening and reduce serious issues from COVID‐19.    AZD7442 is a combination of two proteins (called ‘monoclonal antibodies’) aimed at targeting SARS‐ CoV‐2 (the virus causing COVID‐19). By their combined action, they may be able to prevent the virus from entering into human cells, and thus reduce spreading of the virus in the body, and prevent severe disease and damage

3. Who can take part?

Patients who are 18 years of age or older and are positive for COVID‐19 (within the last five days) and have NOT had the first dose of the coronavirus vaccine can take part in this study. If you are eligible following your test today, please email us so we can send you more information at baccg.ringmeadresearch@nhs.net.

4. Do I have to be a patient at Ringmead?

You do not have to be a patient of Ringmead Medical Practice to take part as long as you meet the study criteria.

5. Do I have to take part?

You have a choice whether or not you would like to participate.  Note that if you have already received the coronavirus vaccine you will not be eligible to take part. If you decide not to take part, you will continue to receive appropriate care for your symptoms or COVID‐19. Your study doctor or treating physician will talk to you about other possible treatments, their risks and benefits. If you are interested contact us on baccg.ringmeadresearch@nhs.net.

6. What will happen if I join the study?

If you do decide to take part please sign up via the above email.  Your study doctor may also review your medical records, clinic notes and overall health and well‐being. Your date of birth will be collected to check your age.

7. Are there any other considerations or risks I need to know about?

If you agree to take part in the main study, you must visit the research site (Birch Hill Medical Centre, Bracknell RG12 7WW) for your appointments.   You are allowed to travel to medical appointments as this is considered as essential travel (Be Part of Research (nihr.ac.uk).

However as you are displaying COVID symptoms, the sponsor will provide a service to take you to and from the site.  The car that you will be in is especially adapted to protect the driver from the possibility of transmission of the virus.  You will not come into contact with the driver at any time.

A carer will be able to travel with you if necessary. You may, of course, drive yourself to the site if you are able.  After you have finished your self‐isolation period, you will be able to travel to your appointment any way you choose; the driver will also be available to you if you are told to self‐isolate whilst you are in the study.  You will be reimbursed any reasonable expenses for travel and refreshments when you are in the main study.