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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGSecurity indexes
Adverse and serious adverse events were recorded
Time frame: Start medication until 14 days
SARS-CoV-2 nucleic acid negative transformation time
SARS-CoV-2 nucleic acid first positive to negative time.
Time frame: Start medication until 14 days
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: 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.
Time frame: Start medication until 14 days
Overall mortality from SARS-CO-2 infection
The rate of patients died of Covid-19 infection.
Time frame: Start medication until 14 days
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.
Time frame: Start medication until 14 days
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.
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Time frame: Start medication until 14 days