Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir

Study Overview
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Brief Summary
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Nirmatrelvir-ritonavir is approved for coronavirus disease 2019 (COVID-19) but not initially recommended in patients with severe renal impairment. Increasing observational data have shown the feasibility of dose-adjusted nirmatrelvir-ritonavir administration in patients with estimated glomerular filtration rate lower than 30 ml/min/1.73 m^2. The study is planned to assess the safety, clinical and virologic outcomes of early oral nirmatrevir-ritonavir treatment of COVID-19 in patients with stage 4 and 5 chronic kidney disease.

Detailed Description
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The objectives of the study are to evaluate the safety and clinical and virologic outcomes of dose-adjusted nirmatrelvir-ritonavir in patients with eGFR lower than 30 ml/min/1.73 m^2. Patients with eGFR greater than 30 ml/min/1.73 m2 and prescribed nirmatrelvir-ritonavir will be used for comparison. In the single-centre study, patients with stage 4 and 5 chronic kidney disease prescribed early treatment dose-adjusted nirmatrelvir-ritonavir will be assessed for the primary endponts of adverse events during or after treatment with nirmatrelvir-ritonavir (starting on or before day 30), serious adverse events and adverse events leading to discontinuation of nirmatrelvir-ritonavir.

Official Title
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Safety and Clinical and Virologic Outcomes in COVID-19 Patients With Chronic Kidney Disease Treated With Nirmatrelvir-ritonavir

Conditions
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Chronic Kidney Disease stage4, Chronc Kidney Disease Stage 5, COVID-19

Intervention / Treatment
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* Drug: Nirmatrelvir/ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 and above. COVID-19 infection and symptom onset no more than 5 days, with or without prior vaccination. WHO CPS 1-4 Indicated for nirmatrelvir-ritonavir treatment Exclusion Criteria: Patients cannot swallow capsules or adhere to protocol. Severe COVID-19 disease, including patients who require oxygen supplement therapy Significant hypersensitivity to nirmatrelvir, ritonavir, or any component of the formulation Patients require co-administration of drugs that are highly dependent on CYP3A4 for clearance and cannot be omitted during the treatment period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nirmatrelvir/ritonavir|Nirmatrelvir-ritonavir (Paxlovid)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event | Adverse events during or after treatment with nirmatrelvir-ritonavir (starting on or before day 30), serious adverse events and adverse events leading to discontinuation of nirmatrelvir-ritonavir | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAT | Time to negative rapid antigen test result | 30 days | 
| Rebound | Rebound of positive rapid antigen test or polymerase chain reaction PCR up to day 30 | 30 days | 
| WHO Clinical Progression Scale CPS | Time to progression to CPS 5 up to day 30 | 30 days | 
| Symptoms | Time to resolution of symptoms | 30 days | 
| Symptomatic rebound | Symptomatic rebound (symptomatic again after resolution of symptom with positive RAT or PCR) | 30 days |