COVID-19
Conditions
Keywords
Hospitalized, paxlovid
Brief summary
The design of this registered study aims to evaluate the efficacy and safety of Paxlovid in the treatment of hospitalized COVID-19 patients, and to explore factors related to the efficacy and safety of Paxlovid.
Interventions
DRUGpaxlovid
Patients treated with PAXLOVID within 5 days of being diagnosed with covid-19 will be included in this group. Patients treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience.
DRUGNo paxlovid
Patients not treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience.
DRUGPaxlovid
Patients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group.
Sponsors
Beijing Chao Yang Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of COVID-19 infection. 2. Presence of at least one high-risk factor, including age ≥60 years, diabetes, hypertension, cardiovascular disease, stroke, chronic liver or kidney disease, cancer, history of smoking or obesity.
Exclusion criteria
* No specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression rates | up to 28 days | The proportion of patients who experienced any of the following events within 28 days after being diagnosed with COVID-19, including all-cause mortality, requiring invasive mechanical ventilation, or being admitted to the intensive care unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| all-cause deaths rates | up to 28 days | The proportion of patients who experienced all-cause mortality within 28 days after being diagnosed with COVID-19. |
| rehospitalization event rates | up to 28 days | The proportion of patients who experienced a rehospitalization event within 28 days after being diagnosed with COVID-19 |
| COVID-19 repositive event rates | up to 28 days | The proportion of patients who experienced a COVID-19 repositive event within 28 days after being diagnosed with COVID-19 |
| adverse drug reaction event | up to 28 days | The proportion of patients who experienced any adverse drug reaction events within 28 days after being diagnosed with COVID-19. |
| thromboembolic event rates | up to 28 days | The proportion of patients who experienced thromboembolic events, including deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction, within 28 days after being diagnosed with COVID-19. |
Contacts
Primary ContactYi Zhang, PhD
Outcome results
None listed