Clinical trial NCT05624840: Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir
Official title: Safety and Clinical and Virologic Outcomes in COVID-19 Patients With Chronic Kidney Disease Treated With Nirmatrelvir-ritonavir
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Chronic Kidney Disease stage4
Chronc Kidney Disease Stage 5
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: adverse event
timeFrame: 30 days
Secondary outcomes:
measure: RAT
timeFrame: 30 days
measure: Rebound
timeFrame: 30 days
measure: WHO Clinical Progression Scale CPS
timeFrame: 30 days
measure: Symptoms
timeFrame: 30 days
measure: Symptomatic rebound
timeFrame: 30 days
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
state: New Territories
Study officials:
References: