NCT05938140

Efficiency and Safety of Paxlovid for COVID-19 Patients With Severe Chronic Kidney Disease

Efficiency and Safety of Paxlovid for the Treatment of COVID-19 Patients With Severe Chronic Kidney Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, open and self-controlled study.The purpose of this study is to evaluate the efficacy and safety of Paxlovid for the treatment of COVID-19 patients with severe chronic kidney disease.

Detailed description

Patients with chronic kidney disease (CKD) have a significantly increased risk of hospitalization or death due to severe COVID-19. A meta-analysis of 348 studies (382,407 COVID-19 and 1,139,979 patients with chronic kidney disease) showed that the incidence of COVID-19 in patients receiving maintenance dialysis was higher than that in CKD patients who did not need renal replacement therapy. The mortality of CKD patients in COVID-19 is higher than that of CKD patients without COVID-19. Another meta-analysis showed that COVID-19 infection was closely related to the mortality of CKD patients. The mortality rate of CKD patients infected with COVID-19 is 5.81 times higher than that of CKD patients not infected with COVID-19. The severe/critical high-risk groups defined in the novel coronavirus Infection Diagnosis and Treatment Program formulated by the National Health and Wellness Commission include kidney disease and maintenance dialysis patients. It is clearly stated in the treatment plan that adult patients with mild or moderate severity and high risk factors should be treated with antiviral therapy within 5 days of onset. Naimatevir tablets/ritonavir tablets (Paxlovid) are commonly used antiviral drugs at present, but it is not recommended for patients with severe renal insufficiency at present, mainly because the data of drug metabolism of Naimatevir/Ritonavir in this population are insufficient. Because the efficacy of Naimatevir/Ritonavir in patients with Covid-19 infection is clear, and the small sample of clinical research data of patients with severe renal insufficiency shows that it has a small safety risk, this study intends to carry out the safety and efficacy study of Naimatevir/Ritonavir in CKD5 patients, and at the same time, carry out the pharmacokinetic study to determine whether Naimatevir/Ritonavir can be used in the treatment of CKD5 patients.

Conditions

• COVID-19
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Nirmatrelvir/ritonavir	Paxlovid is an oral drug for the treatment of COVID-19. It is suitable for adults with mild to moderate COVID-19 patients with high risk factors for progression to severe disease.

Timeline

• Start date: 2023-06-22
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-07-10
• Last updated: 2023-07-10

Locations

1 site across 1 country: China