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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05624840

Collaborator

(none)

100

Enrollment

Location

14.8

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Chronic Kidney Disease stage4 Chronc Kidney Disease Stage 5	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 7, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Outcome Measures

Primary Outcome Measures

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

RAT [30 days]
Time to negative rapid antigen test result
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital, Chinese University of Hong Kong	Shatin	New Territories	Hong Kong	SAR

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chow Kai Ming, Consultant, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05624840

Other Study ID Numbers:

CRE-2022.361

First Posted:

Nov 22, 2022

Last Update Posted:

Nov 25, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Kidney Diseases

Renal Insufficiency, Chronic

Ritonavir

Study Results

No Results Posted as of Nov 25, 2022