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

Work Productivity Losses in the United States Among High-risk Patients With COVID-19 During Acute and Longer-term Follow-up in an Omicron Predominant Period (PULSE-US)

The purpose of this study is to understand how COVID-19 affects people's ability to work and to calculate the costs associated with loss of work.

The study compares two groups of participants who are confirmed to have mild-to moderated COVID-19 and who have high chances of the disease becoming severe.

The two groups are:

People who took the antiviral medication nirmatrelvir-ritonavir (also called Paxlovid) People who were eligible to receive antiviral medication but did not receive any.

The participants will be selected from various health databases in the US between June 2021 and December 2022.

The main goals are:

To look at the characteristics of both groups of participants with COVID-19. To measure how much work these participants missed, including days off and sick leave, and the costs associated with this work loss.

To compare work loss and costs between the two groups of participants, considering differences in their clinical and demographic characteristics.

The study will evaluate at least 30 days of data from participants after they are confirmed to have COVID-19

Study Overview

• Status: Completed
• Conditions: COVID-19 (Coronavirus Disease 2019)
• Intervention / Treatment: Drug: nirmatrelvir-ritonavir

• Study Type: Observational
• Enrollment (Actual): 131005

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

retrospective cohort study of adult, high-risk patients diagnosed with COVID-19 using data from the Merative™ MarketScan® Commercial, Medicare, and Health and Productivity Management (HPM) Databases. The index date for both cohorts will be the date of the first COVID-19 diagnosis and patients will be followed over a 6-month pre-period and variable post-period. The post-period will be a minimum of 30 days to allow patients the opportunity to experience the primary study outcomes of work loss days (absence, STD, and LTD) along with associated indirect costs.

Description

Inclusion Criteria:

• >1 non-diagnostic2 outpatient medical claim in the MarketScan Commercial or Medicare Database with the International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for COVID-19 (U071) between December 16, 2021 (5 days prior to the date of emergency use authorization of NMV/r) and December 1, 2022 (30 days prior to the end of available HPM data); the date of the earliest qualifying claim is the index date.
• Primary beneficiary on their insurance policy (i.e., eligible for inclusion in the MarketScan HPM Database)
• >6 months of continuous enrollment with medical and pharmacy benefits in the MarketScan Commercial or Medicare Database before the index date (baseline period)
• >30 days of continuous enrollment with medical and pharmacy benefits in the MarketScan Commercial or Medicare Database after and including the index date (minimum follow-up period)
• Treated cohort ONLY: ≥1 claim for Paxlovid within 5 days of index (index date and next 4 days)

Exclusion Criteria:

• Evidence of death on the index date or the following day
• Any inpatient admission on the index date or the following day
• ≥1 inpatient claim with a COVID-19 diagnosis in any position on the claim during the 30 days before the index date
• >1 non-diagnostic claim with a diagnosis code for stage 4 or stage 5 chronic kidney disease, end stage renal disease, or a procedure code for dialysis, during the baseline period or on the index date

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated cohort: nirmatrelvir-ritonavir; Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease.	Drug: nirmatrelvir-ritonavir; Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease; Other Names: Paxlovid
Untreated cohort: not receiving any antiviral treatment; Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants According to Age Group: Unmatched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Age Group: Matched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Sex: Unmatched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Sex: Matched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Region of Residence: Unmatched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Region of Residence: Matched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Payer Type: Unmatched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Payer Type: Matched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Insurance Plan Type: Unmatched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Insurance Plan Type: Matched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Industry Type: Unmatched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Industry Type: Matched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Quarter (Q) of Index Year: Unmatched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Quarter of Index Year: Matched Participants	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.	At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Mean Duration of Follow-up: Unmatched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Duration of Follow-up: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Elixhauser Comorbidity Index (ECI): Unmatched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean ECI: Matched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Charlson Comorbidity Index (CCI): Unmatched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean CCI: Matched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Comorbidities: Unmatched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Comorbidities: Matched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of High-risk Conditions Per Participant: Unmatched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of High-risk Conditions Per Participant: Matched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to COVID-19 Vaccination Status: Unmatched Participant	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to COVID-19 Vaccination Status: Matched Participant	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With One or More Prior Hospitalization: Unmatched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With One or More Prior Hospitalization: Matched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With One or More Prior Emergency Room (ER) Visit: Unmatched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With One or More Prior Emergency Room (ER) Visit: Matched Participants	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.	Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With Presence of Any Absence Records: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Number of Absence Days Per Participant Per Month (PPPM): Matched Participants	In this outcome measure mean number of absence days PPPM was reported. Index date was the date of first COVID-19 diagnosis.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Type for Absence Claim: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Cost of Absence Days: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With Any Short Term Disability (STD) Claim: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Number of STD Days PPPM: Matched Participants	In this outcome measure mean number of STD days PPPM was reported. Index date was the date of first COVID-19 diagnosis.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Reason for STD Claim: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Cost of STD Days: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With Any Long Term Disability (LTD) Claim: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Number of LTD Days PPPM: Matched Participants	In this outcome measure mean number of LTD days PPPM was reported. Index date was the date of first COVID-19 diagnosis.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Reason for LTD Claim: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Cost of LTD Days: Matched Participants	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.	From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: July 9, 2025
• First Posted (Actual): July 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Paxlovid; SARS-CoV-1; SARS-CoV; SARS Coronavirus; SARS Virus; omicron
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Severe Acute Respiratory Syndrome; Viral Protease Inhibitors; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; nirmatrelvir and ritonavir drug combination
• Other Study ID Numbers: C4671066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.