Trial Outcomes & Findings for A US Study to Look at Loss of Work and Healthcare Costs for People Affected With Mild-to-moderate COVID 19 Who Have High Chances of the Disease Becoming Severe (NCT NCT07072793)

Data of eligible participants in the US diagnosed with coronavirus disease 2019 (COVID-19) who received nirmatrelvir-ritonavir (NMV/r) \[Paxlovid\] or did not receive any antiviral therapy for COVID-19 was included in this retrospective observational study. In this study, outcome measures were evaluated for actual enrolled numbers (unmatched population) and matched numbers (pseudo population) derived by matching pre-defined characteristics among actual enrolled numbers.

Participants with COVID-19 diagnosis from 16-Dec-2021 to 1-Dec-2022 (approx. 11.5 months of index date identification period) were identified to be included in study. Data was retrieved from 19-Jun-2021 to 31-Dec-2022 (approx. 1.5 years) using the Merative™ MarketScan® database (Commercial and Medicare participants; Health and Productivity Management \[HPM\] database). Data was evaluated per study objectives, from 31-Oct-2024 (study start) to 15-Nov-2024 (study completion) \[approx. 0.5 months\].

Race and Ethnicity were not collected from any participant.

Age group was categorized into following categories: 18-29 years, 30-39 years, 40-49 years, 50-64 years and 65-74 years. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Age group was categorized into following categories: 18-29 years, 30-39 years, 40-49 years, 50-64 years and 65-74 years. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Sex was categorized as: female and male. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Sex was categorized as: female and male. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Region of residence was categorized into following categories: Northeast, North Central, South, West, and other/ missing. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Region of residence was categorized into following categories: Northeast, North Central, South, West and other/ missing. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Payer type was categorized as: commercial and medicare. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Payer type was categorized as: commercial and medicare. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Insurance plan type was categorized into following categories: comprehensive/indemnity, exclusive/preferred provider organization (EPO/PPO), point of service capitation (POS) with or without capitation, health maintenance organization (HMO), consumer driven/ high-deductible health plan (CDHP/HDHP) and missing/unknown. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Insurance plan type was categorized into following categories: comprehensive/indemnity, EPO/PPO, POS with or without capitation, HMO, CDHP/HDHP and missing/unknown. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Industry type was categorized into following categories: finance/insurance/real estate, manufacturing (durable/non-durable goods), retail trade, services, transportation/communications/utilities and other. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Industry type was categorized into following categories: finance/insurance/real estate, manufacturing (durable/non-durable goods), retail trade, services, transportation/communications/utilities and other. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Quarter of index year was categorized into following categories: Q4 2021, Q1 2022, Q2 2022, Q3 2022 and Q4 2022. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Quarter of index year was categorized into following categories: Q4 2021, Q1 2022, Q2 2022, Q3 2022 and Q4 2022. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Duration of follow-up was defined as number of months from (and including) the index date to the end of participants variable-length follow-up period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Duration of follow-up was defined as number of months from (and including) the index date to the end of participants variable-length follow-up period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

ECI was a measure of comorbidity based on ICD-10 codes. ECI score range was from 0-30. A higher score indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

ECI was a measure of comorbidity based on ICD-10 codes. ECI score range was from 0-30. A higher score indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

CCI based on various comorbid conditions such as cerebrovascular disease, chronic pulmonary disease, congestive heart failure, dementia, mild/moderate diabetes, diabetes with chronic complications, hemiplegia/paraplegia, human immunodeficiency virus(HIV), mild liver disease, moderate/severe liver disease, malignancy, metastatic solid tumor, myocardial infarction, peptic ulcer disease, peripheral vascular disease, renal disease, rheumatologic disease was reported. CCI score range was from 0 to 33, where "0"= low comorbid condition and "33"= high comorbid condition, higher scores indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. Data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

CCI based on various comorbid conditions such as cerebrovascular disease, chronic pulmonary disease, congestive heart failure, dementia, mild/moderate diabetes, diabetes with chronic complications, hemiplegia/paraplegia, HIV, mild liver disease, moderate/severe liver disease, malignancy, metastatic solid tumor, myocardial infarction, peptic ulcer disease, peripheral vascular disease, renal disease, rheumatologic disease was reported. CCI score range was from 0 to 33, where "0"= low comorbid condition and "33"= high comorbid condition, higher scores indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Comorbidities were categorized into following categories: cancer (current or history of), cardio/cerebrovascular disease, chronic kidney disease, chronic liver disease, diabetes mellitus, immunocompromised status, lung disease or tuberculosis, neurodevelopmental disorder/complex condition, overweight/obesity or smoking and pregnancy. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category. Participant can have more than 1 comorbidity.

Comorbidities were categorized into following categories: cancer (current or history of), cardio/cerebrovascular disease, chronic kidney disease, chronic liver disease, diabetes mellitus, immunocompromised status, lung disease or tuberculosis, neurodevelopmental disorder/complex condition, overweight/obesity or smoking and pregnancy. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category. Participant can have more than 1 comorbidity.

High risk conditions included cancer, cerebrovascular or peripheral vascular disease, chronic lung disease, chronic liver disease, cystic fibrosis, dementia, diabetes, disability, heart conditions, HIV, hypertension, immunocompromised state(primary immunodeficiencies, prolonged use of corticosteroids or other immunosuppressive medications, and other immunocompromised state), mental health conditions(mood disorder or schizophrenia), overweight or obesity, physical inactivity, pregnancy(current or recent), sickle cell disease or thalassemia, smoking (current or former), solid organ or blood stem cell transplant, substance use disorder, tuberculosis. Index date=date of first COVID-19 diagnosis. Data was reported for unmatched participants, they were further sub-grouped on basis of outcome of COVID-19: eligible for absence from work, short term disability, long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

High risk conditions included cancer, cerebrovascular or peripheral vascular disease, chronic lung disease, chronic liver disease, cystic fibrosis, dementia, diabetes, disability, heart conditions, HIV, hypertension, immunocompromised state (primary immunodeficiencies, prolonged use of corticosteroids or other immunosuppressive medications, and other immunocompromised state), mental health conditions (mood disorder or schizophrenia), overweight or obesity, physical inactivity, pregnancy(current or recent), sickle cell disease or thalassemia, smoking (current or former), solid organ or blood stem cell transplant, substance use disorder, tuberculosis. Index date=date of first COVID-19 diagnosis. Data was reported for matched participants, they were further sub-grouped on basis of outcome of COVID-19: eligible for absence from work, short term disability, long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Number of participants with \>=1 claim for a COVID-19 vaccination during the pre-period was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Number of participants with \>=1 claim for a COVID-19 vaccination during the pre-period was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Prior hospitalization indicated participants who had one or more inpatients visits in the pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Prior hospitalization indicated participants who had one or more inpatients visits in the pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Prior ER visit indicates participants who had one or more ER visits in pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Prior ER visit indicates participants who had one or more ER visits in pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.

Number of participants with presence of any absence records was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.

In this outcome measure mean number of absence days PPPM was reported. Index date was the date of first COVID-19 diagnosis.

Absence days was reported by absence type: sick, disability and recreational absence. Sick, disability and recreational absence were the leaves which participants took during the study period. Sick absence referred to the time away from work due to an employee's own illness or medical condition, this may be also used for bereavement, caring for a family member with a serious health condition, adoption-related medical needs. Disability absence was recorded when an employee was unable to work due to a short-term or long-term disability. Recreational absence referred to the time off taken for non-medical, personal reasons, such as vacation, personal leave, leisure, or wellness days. Index date was the date of first COVID-19 diagnosis. One participant may have more than one type of absence claim.

Estimated sum of wages associated with absence days was calculated as daily wage multiplied by absence days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.

Number of participants with presence of any STD claim was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.

In this outcome measure mean number of STD days PPPM was reported. Index date was the date of first COVID-19 diagnosis.

Reasons for STD were classified as COVID-19 related or non-COVID-19 related or missing/unknown. Index date was the date of first COVID-19 diagnosis.

Estimated sum of wages associated with absence days STD claim was calculated as 70 percentage (%) of daily wage multiplied by STD days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.

Number of participants with presence of any LTD claim was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.

In this outcome measure mean number of LTD days PPPM was reported. Index date was the date of first COVID-19 diagnosis.

Reasons for LTD were classified as COVID-19 related or non-COVID-19 related or missing/unknown. Index date was the date of first COVID-19 diagnosis.

Estimated sum of wages associated with absence days LTD claim was calculated as 70 percent (%) of daily wage multiplied by LTD days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.