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

July 6, 2023 updated by: Li Zhang, Chinese PLA General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Paxlovid group
Patients will take Paxlovid.On the first day, Nematavir tablet 300mg/Ritonavir tablet 100mg orally once, then Nematavir tablet 150mg/ Ritonavir tablet 100mg orally once a day for 4 days. Dialysis patients must took the medication after dialysis.
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.
Other Names:
  • Paxlovid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Security indexes
Time Frame: Start medication until 14 days
Adverse and serious adverse events were recorded
Start medication until 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 nucleic acid negative transformation time
Time Frame: Start medication until 14 days
SARS-CoV-2 nucleic acid first positive to negative time.
Start medication until 14 days
The proportion of disease that progresses to severe or critical type
Time Frame: Start medication until 14 days

Severe type refer to any of the following and cannot be explained by other reasons other than Covid-19 infection:

  1. shortness of breath, RR>30 times/minute:
  2. At rest, when inhaling air, the oxygen saturation is less than 93%;
  3. Partial arterial oxygen pressure (Pa02)/ oxygen concentration (Fi02)<300mmHg.
  4. 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:

  1. Respiratory failure occurs and mechanical ventilation is needed;
  2. Shock:
  3. Other organ failure requires ICU monitoring and treatment.
Start medication until 14 days
Overall mortality from SARS-CO-2 infection
Time Frame: Start medication until 14 days
The rate of patients died of Covid-19 infection.
Start medication until 14 days
Plotting the concentration-time curve of Paxlovid and its semi-logarithmic curve
Time Frame: Start medication until 14 days
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
PK/PD scatter plots
Time Frame: Start medication until 14 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Director: Nan Bai, phD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

June 24, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChinaPLAGH-2023ESP-CKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Nirmatrelvir/ritonavir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe