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
Completed
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Interventions
- Drug: nirmatrelvir-ritonavir
- Registration Number
- NCT07072793
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84584
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treated cohort: nirmatrelvir-ritonavir nirmatrelvir-ritonavir Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease.
- Primary Outcome Measures
Name Time Method Characteristics of Participants treated cohort - Age, age group (18-29, 30-39, 40-49, 50-64, 65-74, 75+) 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Age, age group (18-29, 30-39, 40-49, 50-64, 65-74, 75+) 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Sex 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Sex 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Region of residence (Northeast, North Central, South, West, or other/missing) 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Region of residence (Northeast, North Central, South, West, or other/missing) 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Payer type: (commercial, Medicare Advantage, Medicare supplemental) 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Payer type: (commercial, Medicare Advantage, Medicare supplemental) 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Insurance plan type PPO, HMO, and others 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Insurance plan type PPO, HMO, and others 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Industry type, Employer industry type (oil \& gas extraction/mining, manufacturing \[durable goods\], manufacturing \[non-durable goods\], transportation/communications/utilizes, retail trade, finance/insurance
Characteristics of Participants non-treated cohort 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Industry type, Employer industry type (oil \& gas extraction/mining, manufacturing \[durable goods\], manufacturing \[non-durable goods\], transportation/communications/utilizes, retail trade, finance/insurance
Characteristics of Participants treated cohort - Patients' total hours of absence will be divided by 8 to determine the number of absence days, and so the total days of absence may not be whole numbers for some patients 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - 6 Lifestyle-related diagnoses (e.g., weight and health behaviors) are known to be under-reported in administrative claims 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Number of high-risk conditions 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Number of high-risk conditions 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - COVID-19 vaccination status 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - COVID-19 vaccination status 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Year and quarter (Q1, Q2, Q3, or Q4) of the index date 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Duration of follow-up (months) 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Elixhauser Comorbidity Index (ECI) 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Charlson Comorbidity Index (CCI) 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Year and quarter (Q1, Q2, Q3, or Q4) of the index date 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Duration of follow-up (months) 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Elixhauser Comorbidity Index (ECI) 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Charlson Comorbidity Index (CCI) 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - 6 Lifestyle-related diagnoses (e.g., weight and health behaviors) are known to be under-reported in administrative claims 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Patients' total hours of absence will be divided by 8 to determine the number of absence days, and so the total days of absence may not be whole numbers for some patients 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Prior hospitalization 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Prior hospitalization 19 June 2021 through 31 Dec 2022 Characteristics of Participants treated cohort - Prior ER visit 19 June 2021 through 31 Dec 2022 Characteristics of Participants non-treated cohort - Prior ER visit 19 June 2021 through 31 Dec 2022 Presence of any absence records in treated cohort 19 June 2021 through 31 Dec 2022 Presence of any absence records in non-treated cohort 19 June 2021 through 31 Dec 2022 Sum of Short Term Disability (STD) days in treated cohort 19 June 2021 through 31 Dec 2022 Sum of STD days in non-treated cohort 19 June 2021 through 31 Dec 2022 Reason for STD days in treated cohort 19 June 2021 through 31 Dec 2022 Reason for STD days in non-treated cohort 19 June 2021 through 31 Dec 2022 Estimated sum of wages associated with STD days in treated cohort 19 June 2021 through 31 Dec 2022 Estimated sum of wages associated with STD days in non-treated cohort 19 June 2021 through 31 Dec 2022 Sum of Long Term Disability (LTD) days in treated cohort 19 June 2021 through 31 Dec 2022 Sum of Long Term Disability (LTD) days in non-treated cohort 19 June 2021 through 31 Dec 2022 Reason for LTD days in treated cohort 19 June 2021 through 31 Dec 2022 Reason for LTD days in non-treated cohort 19 June 2021 through 31 Dec 2022 Estimated sum of wages associated with LTD days in treated cohort 19 June 2021 through 31 Dec 2022 Estimated sum of wages associated with LTD days in non-treated cohort 19 June 2021 through 31 Dec 2022
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer New York
🇺🇸New York, New York, United States
Pfizer New York🇺🇸New York, New York, United States