NCT05386433

Paxlovid in the Treatment of COVID-19 Patients With Uremia

The Effect of Paxlovid in the Treatment of COVID-19 Patients With Uremia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, open-label, randomized controlled clinical study to evaluate the effect of Paxlovid on the virus-negative time and disease progression in uremic patients infected with SARS-CoV-2 (omicron variants). This study will enroll maintenance hemodialysis patients infected with SARS-CoV-2 (omicron variants). After signing the informed consent form, the qualified subjects will be randomly stratified 1:1 to standard-of-care (SOC) or SOC plus Paxlovid for five days.

Conditions

• COVID-19
• Uremia

Interventions

Type	Name	Description
DRUG	Paxlovid	Paxlovid contains two medicines: nirmatrelvir and ritonavir. Nirmatrelvir \[PF-07321332\] is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19. Ritonavir is co-administered with nirmatrelvir to help slow its metabolism in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
DRUG	standard-of-care	standard-of-care of COVID-19

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-07-01
• Completion: 2022-08-01
• First posted: 2022-05-23
• Last updated: 2022-05-23

Regulatory

• FDA-regulated drug study