Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

PAXLOVID

Medical condition to be studied

COVID-19
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

21911
Study design details

Main study objective

To estimate viral SARS-CoV-2 rebound rates, prior to the Omicron era and during the Omicron era, in high frequency (volume) SARS-CoV-2 diagnostic testers overall, and among those treated with Paxlovid/nirmatrelvir-ritonavir for SARS-CoV-2 versus those with no evidence of SARS-CoV-2 treatment (untreated for SARS-CoV-2).

Outcomes

SARS-CoV-2 rebound where the main definition of rebound is 1) a positive test (at the index date), followed by a single negative test, followed by a positive test within 28 days or 2) 1 or more positive tests starting at the index date, followed by 1 or more negative tests, followed by a positive test within same 28-day time span.

Data analysis plan

Descriptive statistics among individuals with SARS-CoV-2 in the Helix Respiratory Registry that overlap with the retrospective Komodo Healthcare claims data will be summarized. Means with standard deviations, medians with interquartile ranges will be provided for continuous variables. Numbers and percentages will be provided for dichotomous variables or categorical variables. For exploratory analyses, logistic regression or Cox proportional hazards regression models will be used to identify risk factors and outcomes for SARS-CoV-2 rebound in adjusted analyses. Model selection will balance biological and contextual knowledge for potential confounders with statistical considerations for model fit and the bias versus variance tradeoff. Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP), which will be dated, filed, and maintained by the sponsor.