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

COVID-19 Clinical Trial

— ESPTCSCKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938140
• Other study ID #: ChinaPLAGH-2023ESP-CKD
• Status: Recruiting
• Phase: Phase 4
• Start date: June 22, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: July 2023
• Source: Chinese PLA General Hospital
• Contact: Li Zhang, Doctor
• Phone: 8610-55499226
• Email: zhangl301[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years old

• Patients with chronic kidney disease above stage 4 (eGFR <30ml/min/1.73m2)

• with positive DNA test or antigen test for COVID-19

• Agree to participate in the study and sign the informed consent form voluntarily

Exclusion Criteria:

• Allergic to any component of nimatevir/ritonavir tablets.

• Drugs that are being or need to be taken that are prohibited to be combined with nimatevir tablets or ritonavir tablets as specified in the instructions (including, but not limited to: methidine, amiodarone, propafenone, quinidine, simvastatin, voriconazole, fusidic acid, rifabutine, rifampicin, colchicine, clozapine, quinoline) thiopine, cisapride, simvastatin, dixima, surazadine, fluoxam, oral midazolam and triazolam etc.)

• Renal transplantation failure is taking an immune agent that namatavir tablets/ritonavir tablets can not combine.

• Severe liver injury (Child-Pugh C) or acute liver failure.

• Critically ill patients requiring ventilator-assisted respiratory support.

• patients who cannot take the whole tablet.

• HIV infection with a viral load greater than 400 copies/ml.

• Suspected or confirmed active systemic infections, other than coronavirus pneumonia, that may have an impact on the evaluation of the study.

• Uremia-related complications include acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease.

• Patients who are pregnant or are planning a recent pregnancy.

• The researchers didn't consider the patients to be eligible for the study.

Related Conditions & MeSH terms

• COVID-19
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Security indexes	Adverse and serious adverse events were recorded	Start medication until 14 days
Secondary	SARS-CoV-2 nucleic acid negative transformation time	SARS-CoV-2 nucleic acid first positive to negative time.	Start medication until 14 days
Secondary	The proportion of disease that progresses to severe or critical type	Severe type refer to any of the following and cannot be explained by other reasons other than Covid-19 infection: shortness of breath, RR>30 times/minute: At rest, when inhaling air, the oxygen saturation is less than 93%; Partial arterial oxygen pressure (Pa02)/ oxygen concentration (Fi02)<300mmHg.; The clinical symptoms are getting worse, and the lung imaging shows that the lesion has obviously progressed more than 50% within 24 ~48 hours.; Critical type refer to those who meet one of the following conditions: Respiratory failure occurs and mechanical ventilation is needed; Shock: Other organ failure requires ICU monitoring and treatment.	Start medication until 14 days
Secondary	Overall mortality from SARS-CO-2 infection	The rate of patients died of Covid-19 infection.	Start medication until 14 days
Secondary	Plotting the concentration-time curve of Paxlovid and its semi-logarithmic curve	The concentration-time data of Paxlovid from D1 to D5 were described in a chart, and the dose-time curve and its semi-logarithmic curve were drawn.	Start medication until 14 days
Secondary	PK/PD scatter plots	PK/PD scatter plots were established with Paxlovid's plasma concentration as horizontal coordinate and nucleic acid load as vertical coordinate.	Start medication until 14 days