Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062122) titled 'A study on the association between early antiviral treatment and hospitalization within 30 days in high-risk outpatients with mild COVID-19' on July 3.
Study Type:
Observational
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - COVID-19
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the association between early antiviral treatment (nirmatrelvir/ritonavir, molnupiravir, or ensitrelvir) and 30-day all-cause hospitalization among high-risk outpatients with COVID-19 using a target trial emulation framework.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Adults (aged 18 years or older) with an outpatient diagnosis of COVID-19 who were at high risk of progression to severe disease and did not require hospitalization at diagnosis were eligible. High-risk patients were defined as those aged 65 years or older or those aged 18-64 years with at least one prespecified risk factor for severe disease. Eligible episodes were identified between 1 July 2023 and 31 May 2025, and the qualifying diagnosis date was defined as the index date.
Key exclusion criteria - Episodes were excluded if they met any of the following criteria: simultaneous prescription of multiple target antivirals, in-hospital oral antiviral administration, outpatient remdesivir treatment, or missing essential variables (sex, date of birth, or observation start).
Target Size - 1000000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 10 Day
Anticipated trial start date - 2026 Year 07 Month 04 Day
Last follow-up date - 2026 Year 07 Month 04 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071086
Disclaimer: Curated by HT Syndication.
