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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nirmatrelvir/ritonavir | Drug | Nirmatrelvir-ritonavir (Paxlovid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| RAT | Time to negative rapid antigen test result | 30 days |
| Rebound | Rebound of positive rapid antigen test or polymerase chain reaction PCR up to day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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This is a single centre study of 100 adult patients treated with nirmatrelvir-ritonavir for early COVID-19 disease in the omicron era.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, Chinese University of Hong Kong | Shatin | New Territories | SAR | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37531093 | Derived | Chan GCK, Lui GCY, Wong CNS, Yip SST, Li TCM, Cheung CSK, Sze RKH, Szeto CC, Chow KM. Safety Profile and Clinical and Virological Outcomes of Nirmatrelvir-Ritonavir Treatment in Patients With Advanced Chronic Kidney Disease and Coronavirus Disease 2019. Clin Infect Dis. 2023 Nov 17;77(10):1406-1412. doi: 10.1093/cid/ciad371. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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| 30 days |
| WHO Clinical Progression Scale CPS | Time to progression to CPS 5 up to day 30 | 30 days |
| Symptoms | Time to resolution of symptoms | 30 days |
| Symptomatic rebound | Symptomatic rebound (symptomatic again after resolution of symptom with positive RAT or PCR) | 30 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |