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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05624840
• Other study ID #: CRE-2022.361
• Status: Completed
• Start date: November 7, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 1, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease stage4
• COVID-19
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Nirmatrelvir/ritonavir
Nirmatrelvir-ritonavir (Paxlovid)

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, Chinese University of Hong Kong	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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