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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-07

Study Completion Date

2023-02-01

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Nirmatrelvir/ritonavir

Nirmatrelvir-ritonavir (Paxlovid)

Intervention Type DRUG

Other Intervention Names

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Paxlovid

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No