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

NCT05938140 | Unknown Phase 4

• 1 other identifier: ChinaPLAGH-2023ESP-CKD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• Security indexes

  Adverse and serious adverse events were recorded

  Start medication until 14 days

Secondary Outcomes (5)

• SARS-CoV-2 nucleic acid negative transformation time

  Start medication until 14 days

• The proportion of disease that progresses to severe or critical type

  Start medication until 14 days

• Overall mortality from SARS-CO-2 infection

  Start medication until 14 days

• Plotting the concentration-time curve of Paxlovid and its semi-logarithmic curve

  Start medication until 14 days

• PK/PD scatter plots

  Start medication until 14 days

Study Arms (1)

Paxlovid group

OTHER

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

Interventions

Nirmatrelvir/ritonavir DRUG

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.

Also known as: Paxlovid

Paxlovid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

COVID-19; Renal Insufficiency, Chronic

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nan Bai, phD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Li Zhang, Doctor

CONTACT

8610-55499226; zhangl301@163.com

Sasa Nie, Master

CONTACT

8610-55499341; niesasa14@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 10, 2023
• Study Start: June 22, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)