Table 7.

Summary of the protocol of a target trial to estimate the effect of diabetes without complications on COVID-19 ICU admission

Protocol component	Description
Eligibility criteria	At least one inpatient stay in the baseline period 2015–2019 in a public hospital in Austria and no presence or history of diabetes
Treatment strategies	Refrain from assigning diabetes without complications. Assigning diabetes without complications in the baseline and during the follow-up
Assignment procedures	Random assignment of participants to either strategy at baseline. Participants will be aware of the strategy to which they have been assigned
Follow-up period	Starts in January 2020 before the onset of COVID-19 in Austria and ends at COVID-19 associated ICU admission, death, loss to follow-up, or 24 months after baseline
Outcome	ICU admission with polymerase chain reaction (PCR) confirmed COVID-19 as principal or additional diagnosis
Causal contrasts of interest	Per-protocol effect
Analysis plan	Per-protocol effect estimated via comparison of 16-month risk of COVID-19 associated ICU admission among individuals assigned to each treatment strategy

Authors’ illustration based on [12]