[Preprint]. 2023 May 4:2023.05.03.23289084. [Version 1] doi: 10.1101/2023.05.03.23289084

Table 1.

Protocol of a Target Trial to Estimate the Effect of Paxlovid on the rate of hospitalization in the 28-days following a positive SARS-CoV-2 test

Protocol Component	Description under Target Trial Conditions	Method of Target Trial Emulation in this study
Eligibility criteria	Persons aged 18 and older who have one or more risk factors for severe COVID-19 as per CDC guidelines and who have had an COVID-19 infection during the study period.³¹	Persons aged 18 and older who have one or more risk factors for severe COVID-19 as per CDC guidelines and who have had either a documented COVID-19 diagnosis, or laboratory confirmed positive SARS-CoV-2 test during the study period.³¹
Treatment strategies	Complete course of treatment with Paxlovid within five days of symptom onset.	Complete course of treatment with Paxlovid within five days of the date of laboratory-confirmed SARS-CoV-2 test, or COVID-19 diagnosis.
Assignment procedures	Participants will be randomly assigned to treatment or control at baseline and will be aware of their treatment assignment.	Coarsened exact matching on pre-treatment covariates to ensure exchangeability of treatment and control groups and emulate random assignment.
Follow-up period	28 days following a positive SARS-CoV-2 test	28 days following either positive SARS-CoV-2 test, or COVID-19 diagnosis
Outcome	Hospitalization within follow-up period	Hospitalization within follow-up period
Causal contrasts	Intention-to-treat effect	Intention-to-treat effect
Analysis plan	Intention-to-treat effect estimated via comparison of hospitalization rates among individuals assigned to each treatment arm, adjusting for pre-treatment covariates. Additional analyses to include the main and interaction effects of vaccination.	Coarsened exact matching on pretreatment covariates; Intention-to-treat effect estimated via comparison of hospitalization rates among individuals in each treatment arm in the matched cohort, adjusting for pre-treatment covariates. Additional analyses to include the main and interaction effects of vaccination.