Trials / Completed
CompletedNCT05624840
Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir
Safety and Clinical and Virologic Outcomes in COVID-19 Patients With Chronic Kidney Disease Treated With Nirmatrelvir-ritonavir
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 85 (actual)
- Sponsor
- Chinese University of Hong Kong · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nirmatrelvir/ritonavir | Nirmatrelvir-ritonavir (Paxlovid) |
Timeline
- Start date
- 2022-11-07
- Primary completion
- 2023-01-31
- Completion
- 2023-02-01
- First posted
- 2022-11-22
- Last updated
- 2024-02-07
Locations
1 site across 1 country: Hong Kong
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05624840. Inclusion in this directory is not an endorsement.