Covid-19 Participant Information

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

Thank you for taking the time to read this information.

The RAMPART Trial Team