N/A
Completed N=131,005
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
COVID-19 (Coronavirus Disease 2019)
Source: ClinicalTrials.gov NCT07072793 ↗
Enrolled (actual)
131,005
Serious AEs
—
Results posted
Jan 2026
Primary outcomePrimary: Number of Participants According to Age Group: Unmatched Participants — 57; 686; 545; 6123 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to Age Group: Unmatched Participants |
57; 686; 545; 6123; 556; 6493 | — |
| PRIMARY Number of Participants According to Age Group: Matched Participants |
56; 63; 543; 541; 554; 553 | — |
| PRIMARY Number of Participants According to Sex: Unmatched Participants |
923; 3991; 9466; 42650; 9916; 46815 | — |
| PRIMARY Number of Participants According to Sex: Matched Participants |
914; 914; 9462; 9462; 9916; 9916 | — |
| PRIMARY Number of Participants According to Region of Residence: Unmatched Participants |
120; 657; 3335; 13377; 3386; 13012 | — |
| PRIMARY Number of Participants According to Region of Residence: Matched Participants |
119; 140; 3332; 3258; 3381; 3044 | — |
| PRIMARY Number of Participants According to Payer Type: Unmatched Participants |
1923; 9082; 20005; 90353; 20261; 94703 | — |
| PRIMARY Number of Participants According to Payer Type: Matched Participants |
1902; 1907; 19994; 20013; 20245; 20270 | — |
| PRIMARY Number of Participants According to Insurance Plan Type: Unmatched Participants |
12; 73; 722; 2637; 381; 3277 | — |
| PRIMARY Number of Participants According to Insurance Plan Type: Matched Participants |
12; 19; 721; 601; 380; 548 | — |
| PRIMARY Number of Participants According to Industry Type: Unmatched Participants |
0; 0; 3352; 13278; 3414; 13003 | — |
| PRIMARY Number of Participants According to Industry Type: Matched Participants |
0; 0; 3351; 2729; 3411; 2673 | — |
| PRIMARY Number of Participants According to Quarter (Q) of Index Year: Unmatched Participants |
1; 1255; 3; 10991; 3; 11766 | — |
| PRIMARY Number of Participants According to Quarter of Index Year: Matched Participants |
1; 1; 3; 3; 3; 3 | — |
| PRIMARY Mean Duration of Follow-up: Unmatched Participants |
4.9; 8.3; 4.9; 8.0; 4.9; 8.0 | — |
| PRIMARY Mean Duration of Follow-up: Matched Participants |
4.9; 5.0; 4.9; 5.0; 4.9; 5.0 | — |
| PRIMARY Mean Elixhauser Comorbidity Index (ECI): Unmatched Participants |
1.3; 1.2; 1.3; 1.2; 1.3; 1.2 | — |
| PRIMARY Mean ECI: Matched Participants |
1.3; 1.2; 1.3; 1.2; 1.3; 1.2 | — |
| PRIMARY Mean Charlson Comorbidity Index (CCI): Unmatched Participants |
0.6; 0.6; 0.7; 0.6; 0.7; 0.6 | — |
| PRIMARY Mean CCI: Matched Participants |
0.6; 0.6; 0.7; 0.6; 0.7; 0.6 | — |
| PRIMARY Number of Participants According to Comorbidities: Unmatched Participants |
156; 607; 1796; 6307; 1817; 6596 | — |
| PRIMARY Number of Participants According to Comorbidities: Matched Participants |
150; 132; 1792; 1677; 1811; 1665 | — |
| PRIMARY Number of High-risk Conditions Per Participant: Unmatched Participants |
1.5; 1.5; 1.5; 1.4; 1.4; 1.4 | — |
| PRIMARY Number of High-risk Conditions Per Participant: Matched Participants |
1.5; 1.4; 1.5; 1.4; 1.4; 1.4 | — |
| PRIMARY Number of Participants According to COVID-19 Vaccination Status: Unmatched Participant |
397; 2101; 4689; 21611; 4847; 22478 | — |
| PRIMARY Number of Participants According to COVID-19 Vaccination Status: Matched Participant |
391; 297; 4685; 3761; 4844; 3845 | — |
| PRIMARY Number of Participants With One or More Prior Hospitalization: Unmatched Participants |
41; 291; 421; 2969; 407; 3096 | — |
| PRIMARY Number of Participants With One or More Prior Hospitalization: Matched Participants |
37; 31; 419; 444; 406; 432 | — |
| PRIMARY Number of Participants With One or More Prior Emergency Room (ER) Visit: Unmatched Participants |
287; 1884; 2746; 16507; 2772; 17760 | — |
| PRIMARY Number of Participants With One or More Prior Emergency Room (ER) Visit: Matched Participants |
283; 285; 2738; 2720; 2770; 2742 | — |
| PRIMARY Number of Participants With Presence of Any Absence Records: Matched Participants |
1255; 1331 | — |
| PRIMARY Mean Number of Absence Days Per Participant Per Month (PPPM): Matched Participants |
16.5; 17.8 | — |
| PRIMARY Number of Participants According to Type for Absence Claim: Matched Participants |
587; 624; 92; 100; 1215; 1286 | — |
| PRIMARY Mean Cost of Absence Days: Matched Participants |
434; 468 | — |
| PRIMARY Number of Participants With Any Short Term Disability (STD) Claim: Matched Participants |
1343; 1848 | — |
| PRIMARY Mean Number of STD Days PPPM: Matched Participants |
0.4; 0.5 | — |
| PRIMARY Number of Participants According to Reason for STD Claim: Matched Participants |
220; 327; 1086; 1462; 37; 59 | — |
| PRIMARY Mean Cost of STD Days: Matched Participants |
84; 108 | — |
| PRIMARY Number of Participants With Any Long Term Disability (LTD) Claim: Matched Participants |
50; 74 | — |
| PRIMARY Mean Number of LTD Days PPPM: Matched Participants |
0.02; 0.04 | — |
| PRIMARY Number of Participants According to Reason for LTD Claim: Matched Participants |
1; 1; 33; 58; 16; 15 | — |
| PRIMARY Mean Cost of LTD Days: Matched Participants |
4; 7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT07072793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.