NCT05697055

A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection

A Prospective Multicenter, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Azvudine vs. Nirmatrelvir-Ritonavir in Hospitalized Patients With Moderate to Severe COVID-19 Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The COVID-19 pandemic has become a major public health challenge, and the treatment options for the disease are currently limited. The commonly used oral small-molecule anti-COVID-19 drugs in China are Nirmatrelvir-Ritonavir and Azvudine. These drugs have been tested in pre-marketing clinical trials in patients with non-severe COVID-19 infection and have demonstrated therapeutic effects in inhibiting virus transmission and preventing disease progression. However, until now, the efficacy and safety of these drugs in patients with moderate to severe COVID-19 infections remains unclear. Therefore, this study is aiming to compare the efficacy and safety of Azvudine and Nirmatrelvir-Ritonavir in moderate to severe COVID-19 infections. This study will be a multicenter, randomized, controlled clinical trial study in patients hospitalized with moderate to severe COVID-19 infections. Recovery of clinical symptoms, nucleic acid negative conversion, improvement in oxygenation index, and imaging improvement will be used as study endpoints.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Azvudine	5mg orally, once a day, for no more than 14 days
DRUG	Nirmatrelvir-Ritonavir	Nirmatrelvir 300mg combined with Ritonavir 100mg every 12 hours for 5 days. For patients with 30≤ eGFR \< 60 ml/min, it should be reduced to150mg/100mg Nirmatrelvir-Ritonavir every 12 hours for 5 days

Timeline

• Start date: 2023-01-21
• Primary completion: 2023-05-21
• Completion: 2023-07-21
• First posted: 2023-01-25
• Last updated: 2023-02-27

Locations

1 site across 1 country: China