Copmarison of ensitrelvir and nirmatrelvir/ritonavir

Not Applicable

Recruiting

• Conditions: COVID-19; C01.748.610.763.500

• Registration Number: JPRN-jRCT1031230005
• Lead Sponsor: Yoshimura Yukihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1.18 years old or more
2.Antigen or PCR test positive for SARS-CoV-2
3.0-3 days after symptom onset
4.Having risk factors of severe COVID-19
5.Written informed consent is obtained

Exclusion Criteria

1.Severe adverse events by ensitrelvir or nirmatrelvir/ritonavir
2.Severe kidney failure (eGFR < 30 mL/min)
3.Taking contraindicated medications with ensitrelvir or nirmatrelvir/ritonavir
4.Regarded as inappropriate by study investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
five symptoms 5 or 6 days after starting medications

Secondary Outcome Measures

Name	Time	Method
# 5 symptoms 28 to 30 days after starting medications<br># viral antigen titer 5 or 6 days after starting medications<br># unplanned visit of medical facilities or death<br># adverse events