What are the possible risks of being in the study?
Colchicine may cause tummy upset and blood test abnormalities, rarely including low blood counts, for which you will be monitored. Aspirin thins your blood so increases the risk of bleeding, which rarely can be severe. There is also the unlikely possibility of a severe reaction to any study drug. The Mab treatment (which is in early and rapid development, and currently unlicensed) has been given to over 2000 people with Covid-19 to date, a small number (less than 1 in 100) of whom developed reactions during the infusion or shortly thereafter. The potential side effects of the Mab and plasma transfusions include allergic reactions (rash, fever, chills) and increased difficulty breathing and are easily treated (eg, by slowing or stopping the infusion). The plasma will undergo all the usual testing for the presence of other infections, but a very small risk of infection transmission does remain. Although Tocilizumab has been very rarely associated with liver damage in prolonged use this is not expected to be a problem with the short-term administration in this study. Please ask your hospital doctor if you would like more information. Once you have been included in the study, you and your doctors will know which treatment the computer has allocated for you. Your doctors will be aware of whether there are any particular side effects that they should look out for. Women who are pregnant may be included, however, the effect of some of the treatments on unborn babies is uncertain. Women under the age of 55 will not receive colchicine as it may be harmful in pregnancy or when breast-feeding. All the other treatments (except the Mab) have previously been used in pregnancy for other medical conditions without safety concerns being raised. The Mab has not been given to pregnant women before, but is being tested as pregnant women are at risk from COVID-19. Live vaccines should not be given to babies for at least the first 6 months if you received the Mab. If you do receive treatment and are not already pregnant, as a precaution, we advise that you should not get pregnant within 3 months of the completion of the trial treatment(s).