Copmarison of ensitrelvir and nirmatrelvir/ritonavir

JRCT ID: jRCT1031230005

Registered date:03/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 03/04/2023
• Target sample size: 360
• Study type: Interventional
• Intervention(s): COVID-19 patients are randomly assigned (1:1) to either ensitrelvir or nirmatrelvir/ritonavir. Efficacy of the two medications are assessed.

Outcome(s)

• Primary Outcome: five symptoms 5 or 6 days after starting medications

Secondary Outcome

# 5 symptoms 28 to 30 days after starting medications
# viral antigen titer 5 or 6 days after starting medications
# unplanned visit of medical facilities or death
# adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yoshimura Yukihiro