Efficiency and Safety of Paxlovid for COVID-19 Patients With Severe Chronic Kidney Disease
NCT ID: NCT05938140
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2023-06-22
2025-05-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Li Zhang
Professor
Principal Investigators
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Nan Bai, phD
Role: STUDY_DIRECTOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ChinaPLAGH-2023ESP-CKD
Identifier Type: -
Identifier Source: org_study_id
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