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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Security indexes | Adverse and serious adverse events were recorded | Start medication until 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 nucleic acid negative transformation time | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, Doctor | Contact | 8610-55499226 | zhangl301@163.com | |
| Sasa Nie, Master | Contact | 8610-55499341 | niesasa14@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Nan Bai, phD | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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|
Severe type refer to any of the following and cannot be explained by other reasons other than Covid-19 infection:
Critical type refer to those who meet one of the following conditions:
| Start medication until 14 days |
| Overall mortality from SARS-CO-2 infection | 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 | 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 | 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |