Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062764) titled 'A study of whether initiating an oral SARS-CoV-2 antiviral (ensitrelvir, nirmatrelvir/ritonavir, or molnupiravir) on the day of outpatient COVID-19 diagnosis reduces newly recorded subacute post-COVID symptoms (impaired smell, impaired taste, fatigue, cough, appetite loss) during days 29-60 after diagnosis, using a Japanese claims database (target trial emulation)' on Sept. 1.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka, Graduate School of Medicine Faculty of Medicine

Condition: Condition - COVID-19 (acute COVID-19 diagnosed in outpatient care). The outcome is subacute post-COVID symptoms (impaired smell, impaired taste, fatigue, cough, appetite loss). Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Using the JMDC insurer claims database, to estimate whether initiating an oral SARS-CoV-2 antiviral (ensitrelvir, nirmatrelvir/ritonavir, or molnupiravir) on the day of outpatient COVID-19 diagnosis (day 0), compared with not initiating, reduces the risk of newly recorded subacute post-COVID symptoms (impaired smell/taste, fatigue, cough, appetite loss) during days 29-60 after diagnosis (the claim month following the index month, m1), within a day-0 new-user target trial emulation framework. Propensity-score overlap weighting and inverse-probability-of-censoring weighting (IPCW) are used. This registration is performed before viewing any treatment effect. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Age 18 years or older at index. (2) The first eligible outpatient episode with a confirmed acute COVID-19 diagnosis (standard disease codes 8850104 / 8850701; suspected-flag records excluded) between 1 April 2024 and 31 March 2025. (3) Continuous enrollment from day -365 through day 0. (4) Not hospitalised on day 0. (5) No acute COVID-19 diagnosis in the prior 180 days. (6) A non-empty drug-specific eligibility set (no claims-identifiable contraindication or contraindicated co-medication for at least one of the three oral antivirals: ensitrelvir, nirmatrelvir/ritonavir, molnupiravir). Exposure is dispensing of an eligible oral antiviral on day 0; the comparator is no qualifying day-0 initiation. The JMDC insurer claims database is used. Key exclusion criteria - Hospitalised on day 0. An acute COVID-19 diagnosis in the prior 180 days. Not continuously enrolled from day -365 through day 0. Only suspected-flag records. An empty drug-specific eligibility set (a claims-identifiable contraindication or contraindicated co-medication for all three oral antivirals). Target Size - 758000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 14 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071861

Disclaimer: Curated by HT Syndication.