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

Pfizer

Status: Completed

Conditions: COVID-19 (Coronavirus Disease 2019)

Treatments: Drug: nirmatrelvir-ritonavir

Study type: Observational

Funder types: Industry

Identifiers

NCT07072793

C4671066

Details and patient eligibility

About

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

Enrollment: 131,005 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

131,005 participants in 2 patient groups

Treated cohort: nirmatrelvir-ritonavir

Description:

Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease.

Treatment:

Drug: nirmatrelvir-ritonavir

Untreated cohort: not receiving any antiviral treatment

Description:

Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease.