Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063381) titled 'A claims database study evaluating the association between ensitrelvir treatment and hospitalization among outpatients aged 75 years or older with COVID-19' on Oct. 22.

Study Type: Observational

Primary Sponsor: Institute - Shionogi & Co., Ltd.

Condition: Condition - Coronavirus disease 2019 (COVID-19) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the association between ensitrelvir treatment and all-cause hospitalization within 7 days after COVID-19 diagnosis and treatment initiation among Japanese outpatients aged 75 years or older, using a claims database derived from the Late-Stage Elderly Healthcare System. Patients treated with ensitrelvir will be compared separately with patients receiving no antiviral treatment and those treated with molnupiravir. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 75 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients must meet all of the following criteria: 1.A COVID-19 diagnosis and dispensing of an eligible treatment are recorded on the same date during the indexing period from April 23, 2024, through February 28, 2025. 2.The COVID-19 diagnosis used to identify the index date is recorded in an outpatient claim. 3.An outpatient medical procedure or outpatient prescription or dispensing record is present on the index date. 4.The patient is aged 75 years or older on the index date. 5.Continuous medical and pharmacy data are available for at least 12 months before the index date. 6.The patient's observation end month is at least one month after the month containing the index date, or the patient dies during the month containing the index date. 7.The patient can be classified into one of the following cohorts according to treatment received on the index date: ensitrelvir, no antiviral treatment, or molnupiravir. Key exclusion criteria - Patients meeting any of the following criteria will be excluded: 1.Missing age or sex. 2.A COVID-19 diagnosis or treatment with ensitrelvir, molnupiravir, nirmatrelvir/ritonavir, or remdesivir within 180 days before the index date. 3.Dispensing of more than one COVID-19 antiviral medication on the index date. 4.An inpatient or Diagnosis Procedure Combination claim with an admission date equal to the index date, or evidence of inpatient medical procedures on the index date. 5.Use of medications contraindicated with ensitrelvir or nirmatrelvir/ritonavir within 90 days before or on the index date. Target Size - 100000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 13 Day Anticipated trial start date - 2026 Year 10 Month 13 Day Last follow-up date - 2027 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072550

Disclaimer: Curated by HT Syndication.