What are the possible risks of being in the study?
Colchicine and baricitinib 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 4000 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 include allergic reactions (rash, fever, chills) and increased difficulty breathing and are easily treated (eg, by slowing or stopping the infusion). At some sites, other treatments may also be assessed. 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. Pregnant women will not receive baricitinib or colchicine as they 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. 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). If you receive the Mab it is recommended you do not receive a COVID-19 vaccine (or second dose) for 90 days so it does not interfere with your response. The risk of repeat infection during this period is very small as we know that the immunity gained from COVID-19 infection is similar to that provided by the vaccine and lasts at least three months after infection.