COVID-19 pandemic: Guidance for Add-Aspirin participants

In the current pandemic situation, we know that trial participants may have concerns or questions about taking 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 Add-Aspirin participants will be affected by recent NHS recommendations due to coronavirus (COVID-19). The current recommendations from the NHS are 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:

• anyone who is currently undergoing active chemotherapy for solid cancers (this may be relevant to a small number of trial participants who have joined the trial recently and are still receiving chemotherapy for bowel, stomach or oesophageal cancer)
• anyone who is receiving antibody treatment (e.g Herceptin (trastuzumab) for breast cancer)

Many participants undergoing follow-up in the trial will not be directly affected by these recommendations, however, you may still have concerns about attending follow-up appointments or tests. Alternative arrangements, including consultations by telephone may be available locally and your site will inform you.

Taking medication
Participants in the trial are advised to use paracetamol rather than ibuprofen for fever or flu like symptoms (because ibuprofen should not normally be used at the same time as aspirin).

There have been a number of reports, particularly on social media, suggesting that non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, could worsen symptoms of COVID-19. The regulatory body for Europe (the European Medicines Agency) have recently issued a statement https://www.ema.europa.eu/en/news/ema-gives-advice-use-non-steroidal-anti-inflammatories-covid-19 indicating that there is currently no scientific evidence to support these reports and no reason for patients taking NSAIDs regularly to interrupt their treatment. Whilst aspirin is classed as a NSAID, the doses given to participants in the trial are not expected to have the anti-inflammatory effects associated with ibuprofen and other similar drugs. Given this, and the guidance from the regulatory agency, trial participants are not being recommended to stop their treatment at this time. However, we are constantly reviewing/monitoring the situation and will let you know if there are any changes to the advice given.

Although we are not recommending it for most participants, a break from taking trial tablets is possible and may be recommended in individual cases. Please follow the advice of your study doctor.

There could also be a delay in receiving your trial medication, but we are working hard to minimise that possibility. Hospitals may be able to post trial tablets to you.

We hope that you all stay well. We will be monitoring the situation continuously and we will post further updates on our website (http://www.addaspirintrial.org/).

The Add-Aspirin Team