COVID-19, Chronic Kidney Disease stage4, Chronc Kidney Disease Stage 5
Conditions
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.
Interventions
Nirmatrelvir-ritonavir (Paxlovid)
Sponsors
Chinese University of Hong Kong
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Hong Kong
Outcome results
None listed