What are the possible risks of being in the study?
Baricitinib may cause tummy upset and blood test abnormalities, rarely including low blood counts, for which you will be monitored. They may increase your risk of other infections, as might high dose dexamethasone which may also disturb sleep and (in people with diabetes) raise blood sugar.
Empagliflozin may cause urine or genital tract infections, like thrush. If you have diabetes, empagliflozin also lowers blood sugar in people taking insulin or some other diabetes treatments so your doctors may adjust the doses of those; it may also cause a condition called ketoacidosis (which rarely can be life-threatening), which is treated with a drip and insulin. You will be monitored for this with daily fingerprick blood or urine tests. There is also the unlikely possibility of a severe reaction to any study drug.
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 empagliflozin as they may be harmful in pregnancy or when breast-feeding. The other treatments have previously been used in pregnancy for other medical conditions without safety concerns being raised.