COVID-19 Clinical Trial
Official title:
Safety and Clinical and Virologic Outcomes in COVID-19 Patients With Chronic Kidney Disease Treated With Nirmatrelvir-ritonavir
Verified date | February 2024 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | February 1, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital, Chinese University of Hong Kong | Shatin | New Territories |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | RAT | Time to negative rapid antigen test result | 30 days | |
Secondary | Rebound | Rebound of positive rapid antigen test or polymerase chain reaction PCR up to day 30 | 30 days | |
Secondary | WHO Clinical Progression Scale CPS | Time to progression to CPS 5 up to day 30 | 30 days | |
Secondary | Symptoms | Time to resolution of symptoms | 30 days | |
Secondary | Symptomatic rebound | Symptomatic rebound (symptomatic again after resolution of symptom with positive RAT or PCR) | 30 days |
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