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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Chronic Kidney Disease stage4; Chronc Kidney Disease Stage 5
• Intervention / Treatment: Drug: Nirmatrelvir/ritonavir

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 Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong, SAR
      • Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a single centre study of 100 adult patients treated with nirmatrelvir-ritonavir for early COVID-19 disease in the omicron era.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; COVID-19; Kidney Diseases; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Nirmatrelvir; Nirmatrelvir and ritonavir drug combination
• Other Study ID Numbers: CRE-2022.361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No