Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-28 @ 10:31 PM
Study NCT ID:
NCT07072793
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2024-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-24', 'releaseDate': '2025-11-14'}, {'releaseDate': '2025-12-18'}], 'estimatedResultsFirstSubmitDate': '2025-11-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719967', 'term': 'nirmatrelvir and ritonavir drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84584}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2024-11-15', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics of Participants treated cohort - Age, age group (18-29, 30-39, 40-49, 50-64, 65-74, 75+)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Age, age group (18-29, 30-39, 40-49, 50-64, 65-74, 75+)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Sex', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Sex', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Region of residence (Northeast, North Central, South, West, or other/missing)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Region of residence (Northeast, North Central, South, West, or other/missing)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Payer type: (commercial, Medicare Advantage, Medicare supplemental)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Payer type: (commercial, Medicare Advantage, Medicare supplemental)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Insurance plan type PPO, HMO, and others', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Insurance plan type PPO, HMO, and others', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022', 'description': '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'}, {'measure': 'Characteristics of Participants non-treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022', 'description': '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'}, {'measure': 'Characteristics of Participants treated cohort - Year and quarter (Q1, Q2, Q3, or Q4) of the index date', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Year and quarter (Q1, Q2, Q3, or Q4) of the index date', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Duration of follow-up (months)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Duration of follow-up (months)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Elixhauser Comorbidity Index (ECI)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Elixhauser Comorbidity Index (ECI)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Charlson Comorbidity Index (CCI)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Charlson Comorbidity Index (CCI)', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': "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", 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': "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", 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - 6 Lifestyle-related diagnoses (e.g., weight and health behaviors) are known to be under-reported in administrative claims', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': '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', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Number of high-risk conditions', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Number of high-risk conditions', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - COVID-19 vaccination status', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - COVID-19 vaccination status', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Prior hospitalization', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Prior hospitalization', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants treated cohort - Prior ER visit', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Characteristics of Participants non-treated cohort - Prior ER visit', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Presence of any absence records in treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Presence of any absence records in non-treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Sum of Short Term Disability (STD) days in treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Sum of STD days in non-treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Reason for STD days in treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Reason for STD days in non-treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Estimated sum of wages associated with STD days in treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Estimated sum of wages associated with STD days in non-treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Sum of Long Term Disability (LTD) days in treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Sum of Long Term Disability (LTD) days in non-treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Reason for LTD days in treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Reason for LTD days in non-treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Estimated sum of wages associated with LTD days in treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}, {'measure': 'Estimated sum of wages associated with LTD days in non-treated cohort', 'timeFrame': '19 June 2021 through 31 Dec 2022'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SARS Coronavirus', 'SARS Virus', 'SARS-CoV', 'SARS-CoV-1', 'Paxlovid', 'omicron'], 'conditions': ['COVID-19 (Coronavirus Disease 2019)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4671066', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe two groups are:\n\nPeople who took the antiviral medication nirmatrelvir-ritonavir (also called Paxlovid) People who were eligible to receive antiviral medication but did not receive any.\n\nThe participants will be selected from various health databases in the US between June 2021 and December 2022.\n\nThe main goals are:\n\nTo 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.\n\nTo compare work loss and costs between the two groups of participants, considering differences in their clinical and demographic characteristics.\n\nThe study will evaluate at least 30 days of data from participants after they are confirmed to have COVID-19"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>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.\n* Primary beneficiary on their insurance policy (i.e., eligible for inclusion in the MarketScan HPM Database)\n* \\>6 months of continuous enrollment with medical and pharmacy benefits in the MarketScan Commercial or Medicare Database before the index date (baseline period)\n* \\>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)\n* Treated cohort ONLY: ≥1 claim for Paxlovid within 5 days of index (index date and next 4 days)\n\nExclusion Criteria:\n\n* Evidence of death on the index date or the following day\n* Any inpatient admission on the index date or the following day\n* ≥1 inpatient claim with a COVID-19 diagnosis in any position on the claim during the 30 days before the index date\n* \\>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'}, 'identificationModule': {'nctId': 'NCT07072793', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'C4671066'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Drug: nirmatrelvir-ritonavir']}, {'label': '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.'}], 'interventions': [{'name': 'nirmatrelvir-ritonavir', 'type': 'DRUG', 'otherNames': ['Paxlovid'], 'description': 'Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease', 'armGroupLabels': ['Treated cohort: nirmatrelvir-ritonavir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-14', 'type': 'RELEASE'}, {'date': '2025-11-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Pfizer'}}}}