Evaluating Paxlovid for COVID-19 in Patients with Severe Chronic Kidney Disease
Efficiency and Safety of Paxlovid for the Treatment of COVID-19 Patients With Severe Chronic Kidney Disease
This study is testing if the antiviral treatment Paxlovid is safe and helpful for people with severe chronic kidney disease who also have COVID-19.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05938140 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of Paxlovid, an antiviral treatment, in patients suffering from severe chronic kidney disease who are also infected with COVID-19. It is a prospective, single-center, open-label, and self-controlled study, focusing on patients with an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73m². Given the heightened risk of severe outcomes in this population, the study seeks to determine if Paxlovid can be safely administered and provide therapeutic benefits. The research will involve monitoring patient responses and potential side effects associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with stage 4 chronic kidney disease and a confirmed COVID-19 infection.
Not a fit: Patients with severe liver injury, those requiring ventilator assistance, or those allergic to components of Paxlovid may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective treatment option for COVID-19 patients with severe chronic kidney disease, potentially reducing hospitalization and mortality rates.
How similar studies have performed: While there is limited data on the use of Paxlovid in this specific population, other studies have shown promising results for antiviral treatments in high-risk COVID-19 patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing
- Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Li Zhang, Doctor
- Email: zhangl301@163.com
- Phone: 8610-55499226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.