This is a prospective, single-center, open and self-controlled study.The purpose of thisstudy is to evaluate the efficacy and safety of Paxlovid for the treatment of COVID-19patients with severe chronic kidney disease.
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.
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 Name: Paxlovid
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.
Chinese PLA General Hospital
Beijing, Beijing, China
Investigator: Nan Bai, phD
Contact: 8610-66937166
bainan82@126.com
Li Zhang, Doctor
8610-55499226
zhangl301@163.com
Sasa Nie, Master
8610-55499341
niesasa14@163.com
Nan Bai, phD, Study Director
Chinese PLA General Hospital