2nd July 2020
The RAMPART Trial Management Group have been reviewing the COVID-19 situation on a regular basis. Now that we know a little more about COVID-19, the group agree that the potential benefits of treatment in the RAMPART trial outweigh the risks for the majority of our participants. The RAMPART trial has therefore now officially re-opened in the UK.
All existing trial participants will be offered the opportunity to resume their trial treatment, provided this does not extend beyond one year after their first dose. Participants will be contacted by their local study team in the coming weeks to discuss their options.
The trial will also re-open to new participants. Anyone interested in participating in the RAMPART trial should discuss this with their doctor.
24th March 2020
In the current pandemic situation, we know that trial participants may have concerns or questions about their trial treatment and attending follow-up appointments. We have provided some general guidance below. However, your study doctor or nurse will be best placed to advise on your individual circumstances and the services available at your local hospital. If they make any additional recommendations, you should follow these.
Attending follow-up appointments
Some RAMPART participants will be affected by recent NHS recommendations due to coronavirus (COVID-19). The current recommendation is that the following groups of individuals should self-isolate and are strongly advised to stay at home at all times and avoid face-to-face contact for at least the next 12 weeks:
If you have received immunotherapy within the last 3 months in the RAMPART trial (either Durvalumab or a combination of Durvalumab and Tremelimumab) or are currently receiving steroid treatment, you are advised to follow these recommendations. Alternative arrangements, including consultations by telephone may be available locally and your site will inform you.
We hope that you all stay well. We will be monitoring the situation continuously and will post any updates via our website.
24th March 2020
COVID-19 Guidance for RAMPART Participants
The team of doctors and researchers responsible for the RAMPART study review the potential risks and benefit of the research on an ongoing basis. As we have learned more about the coronavirus pandemic (also referred to as Covid-19) and the illness it can cause we have decided to make some important changes to the RAMPART study. We have made these changes to in order to protect participants like you.
What are the changes?
Participants will no longer receive any RAMPART study treatment. We will review this decision on an ongoing basis as more information becomes available. Depending on how long the coronavirus pandemic continues it may mean that you will not receive any more study treatment.
You will still be followed up as part of the study, but your study doctor may make changes to the frequency and type of follow-up visits you will have, according to what is most appropriate for you. This may include attendance at hospital when that is a safe option, however for the next couple of months you may have telephone follow-up only. This all means you may have a different follow-up schedule to other people on the study. It is vitally important that you contact your study doctor if you have concerns about your health in the coming months, just as you would have done before this change.
No new participants will be invited to take part in the study until the Covid-19 pandemic situation improves.
Why have these changes been made?
We have made these changes after reviewing the available evidence and deciding that these changes are in the best interest of RAMPART study participants.
We know that the drugs that you are taking as part of the RAMPART study can cause side effects that are best treated with another class of drug called steroids. We have learned that steroid treatment can lead to a greater risk of Covid-19 related illness, which in some cases can be fatal.
We also know that attending hospital for treatment or study-related visits may increase your risk of exposure to Covid-19 compared to not attending hospital.
As the number of cases of Covid-19 rise, these risks outweigh the possible benefit you might receive from treatment in the RAMPART study.
What if new information comes available?
We review all of the changes we have made to the RAMPART study on an ongoing basis as we learn more about Covid-19. As soon as it is safe, we will ask you to return to your regular study follow-up schedule. However, we do not know yet whether you will be able to start your study treatment again.
We will continue to post relevant information about the RAMPART study on our website: www.rampart-trial.org