Clinical trial
A Registry Study of Patients Hospitalized With Confirmed COVID-19
Name
CYH-PHARM1
Description
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.
Trial arms
Trial start
2023-03-30
Estimated PCD
2023-06-30
Trial end
2023-12-30
Status
Not yet recruiting
Treatment
paxlovid
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.
Arms:
Paxlovid（Within 5 days after the diagnosis of COVID-19）
Other names:
paxlovid within initial 5 days
No 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.
Arms:
No paxlovid used
Paxlovid
Patients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group.
Arms:
Paxlovid （More than 5 days after the diagnosis of COVID-19）
Other names:
Paxlovid outside of the initial 5 days
Size
488
Primary endpoint
Disease progression rates
up to 28 days
Eligibility criteria
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 exclusion criteria in this study.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '28 Days', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Residual specimen, plasma, 1 ml. Each specimen will be uniquely identified to ensure that patient privacy is not compromised.'}, 'enrollmentInfo': {'count': 488, 'type': 'ESTIMATED'}}
Updated at
2023-03-31
1 organization
Organization
Beijing Chao Yang Hospital