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This study is a single-center, open-label, randomized controlled clinical study to evaluate the effect of Paxlovid on the virus-negative time and disease progression in uremic patients infected with SARS-CoV-2 (omicron variants).
This study will enroll maintenance hemodialysis patients infected with SARS-CoV-2 (omicron variants).
After signing the informed consent form, the qualified subjects will be randomly stratified 1:1 to standard-of-care (SOC) or SOC plus Paxlovid for five days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard-of-care | Placebo Comparator | Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc. |
|
| standard-of-care plus Paxlovid | Experimental | standard-of-care of COVID-19 plus Paxlovid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paxlovid | Drug | Paxlovid contains two medicines: nirmatrelvir and ritonavir. Nirmatrelvir [PF-07321332] is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19. Ritonavir is co-administered with nirmatrelvir to help slow its metabolism in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus. |
| Measure | Description | Time Frame |
|---|---|---|
| time of negative conversion of SARS-CoV-2 nucleic acid | Time from first positive to negative of SARS-CoV-2 nucleic acid | up to 60 days |
| Proportion of ICU transfer or disease progression to severe or critical illness | up to 60 days |
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Inclusion Criteria:
Exclusion Criteria:
HIV infection and the viral load is greater than 400 copies/ml. Suspected or confirmed active systemic infections that may have an impact on the study evaluation except for COVID-19.
Acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease caused by uremia-related complications.
Allergic to any ingredients of Paxlovid.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014511 | Uremia |
| 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 |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| standard-of-care | Drug | standard-of-care of COVID-19 |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |