2nd July 2020
The RAMPART trial has now officially re-opened in the UK. All participating sites will need to complete the re-activation process before they are ready to start recruiting new patients and treating existing patients again. Please contact the RAMPART team if you have not received an email outlining this process.
We have made amendments to the trial protocol in response to the Covid-19 pandemic. The study will now allow extended treatment breaks for the management of patients during the Covid-19 pandemic. There are also new inclusion/exclusion criteria relating to Covid-19.
All trial participants will be offered the opportunity to resume their trial treatment, provided this does not extend beyond one year after their first dose. The local study team will be in contact with all patients to discuss their optionss.
19th March 2020
In the light of the rapidly evolving situation with COVID-19 in the UK, we are implementing a number of amendments to the RAMPART trial with immediate effect. This builds on initial, more general COVID-19 correspondence that was sent on behalf of our unit director on 13th March 2020.
- Participant accrual to RAMPART is suspended
- This includes all patients who have been screened or who have already provided consent to participate
- No further screening or pre-treatment visits are required
- Trial treatment for all participants is also suspended
- This includes participants who have been randomised, but have not yet commenced treatment
- The need for clinic visits for trial follow-up should be assessed on an individual participant basis, and should be at the discretion of the patient’s treating clinician
- Follow-up to ensure participant safety and to manage developing side-effects of treatment already received should be prioritised
- We advise clinicians to assess the risk for individual participants of travel to, and attendance at hospital for protocol-mandated imaging and clinical assessment and adapt the schedule as they feel appropriate
- Telephone follow-up in place of clinic visits is acceptable where possible and safe
Communication with Patients
Reporting SAEs and Data Collection
- Please continue to report any SAEs as per the usual reporting route, faxing the SAE CRF to 0207 670 4818. A member of the team will confirm receipt of the SAE form.
- Please send CRFs via galaxkey as we are currently unable to process any CRFs received by post. If you do not have a galaxkey account, let us know and we can create one for you.
- Depending on the follow-up participants at your site receive in the coming months we can advise you on the CRFs that you should complete
Reason for this Amendment
- Patients receiving checkpoint inhibitor treatments are susceptible to developing side effects that require the use of steroids. Steroids are likely to expose patients to an unacceptable added risk of COVID-19 related morbidity and mortality
- For participants already on the study, bringing them to hospital for treatment or study related visits exposes them to a risk of COVID-19, which they otherwise might not have had
- With rising COVID-19 infection these risks outweighs the uncertain benefit of adjuvant treatment
Review of this Amendment
- We will review all of these decisions on a regular basis and will notify you of any changes
- The MRHA have confirmed that these changes to RAMPART can be implemented without a substantial amendment. We have also informed the Research Ethics Committee and AstraZeneca
- Please file a copy of this correspondence in your Investigator Site File
- Please inform your R&D department of these amendments and advise them to contact us if they need further information
- In line with government advice, all MRC CTU staff are working from home where possible. We have diverted our work telephone numbers, so you can reach any member of the trial team using the telephone numbers listed in the protocol
- You can also email the trial inbox: email@example.com
- We will forward clinical questions to the Chief Investigator or Clinical Reviewer for advice as necessary
- We will continue to post relevant information on our trial website: www.rampart-trial.org