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

Completed

• Conditions: Chronic Kidney Disease stage4; COVID-19; Chronc Kidney Disease Stage 5

• Registration Number: NCT05624840
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-11-07
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-22
• Primary Completion: 2023-01-31
• Study Completion: 2023-02-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adverse event	30 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong; 🇭🇰 Shatin, New Territories, Hong Kong