Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062526) titled 'A study comparing the 90-day risk of cardiovascular events (hospitalization for myocardial infarction, heart failure, or stroke) after initiation of oral antivirals (nirmatrelvir/ritonavir, molnupiravir, or ensitrelvir) among older outpatients with COVID-19' on Aug. 9.

Study Type: Observational

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

Condition: Condition - COVID-19 (outpatient episodes in late-elderly adults). The outcome is cardiovascular events (hospitalization for acute myocardial infarction, heart failure, or stroke). Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Using JMDC-provided Japanese late-elderly claims data, to compare 90-day cardiovascular outcomes after initiation of oral antivirals (nirmatrelvir/ritonavir, molnupiravir, or ensitrelvir) among older outpatients with COVID-19. Three pairwise comparisons are conducted in an active-comparator initiator design, with the average treatment effect in the clinical overlap-weighted population as the primary estimand. Basic objectives2 - Safety

Eligibility: Age-lower limit - 75 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Outpatient COVID-19 episodes in JMDC-provided Japanese late-elderly claims data in which one of the target oral antivirals (nirmatrelvir/ritonavir, molnupiravir, or ensitrelvir) was initiated on the diagnosis day or the following day. Initiation from July 1, 2023, through December 31, 2024, with follow-up through March 31, 2025. Pairwise analyses required claims-observable eligibility for both drugs and exactly one comparator initiated on the diagnosis day or the following day. A 365-day baseline window was ensured. Key exclusion criteria - None of the three target antivirals initiated on the diagnosis day or the following day. Not meeting claims-observable eligibility for both drugs in a pairwise analysis. More than one comparator drug initiated on the diagnosis day or the following day. Initiation outside the study period. Target Size - 99289

Recruitment Status: Recruitment status - Completed 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 04 Month 14 Day Last follow-up date - 2026 Year 08 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071574

Disclaimer: Curated by HT Syndication.