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Completed

NCT Number: NCT05624840

Safety and Clinical and Virologic Outcomes in CKD Patients 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, SAR, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nirmatrelvir/ritonavir

Drug

Nirmatrelvir-ritonavir (Paxlovid)

Other names: Paxlovid

Primary outcomes

  1. adverse event

    Time frame: 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 outcomes

  1. RAT

    Time frame: 30 days

    Time to negative rapid antigen test result

  2. Rebound

    Time frame: 30 days

    Rebound of positive rapid antigen test or polymerase chain reaction PCR up to day 30

  3. WHO Clinical Progression Scale CPS

    Time frame: 30 days

    Time to progression to CPS 5 up to day 30

  4. Symptoms

    Time frame: 30 days

    Time to resolution of symptoms

  5. Symptomatic rebound

    Time frame: 30 days

    Symptomatic rebound (symptomatic again after resolution of symptom with positive RAT or PCR)

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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