A Registry Study of Patients Hospitalized With Confirmed COVID-19

COVID-19 Clinical Trial

Official title:

A Registry Study of Patients Hospitalized With Confirmed COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05792865
• Other study ID #: CYH-PHARM1
• Status: Not yet recruiting
• Start date: March 30, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Beijing Chao Yang Hospital
• Contact: Yi Zhang, PhD
• Phone: +86 01085231464
• Email: jeffzhang1619[@]outlook.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 488
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• 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.
• 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.
• Paxlovid
Patients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease progression rates	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.	up to 28 days
Secondary	all-cause deaths rates	The proportion of patients who experienced all-cause mortality within 28 days after being diagnosed with COVID-19.	up to 28 days
Secondary	rehospitalization event rates	The proportion of patients who experienced a rehospitalization event within 28 days after being diagnosed with COVID-19	up to 28 days
Secondary	COVID-19 repositive event rates	The proportion of patients who experienced a COVID-19 repositive event within 28 days after being diagnosed with COVID-19	up to 28 days
Secondary	adverse drug reaction event	The proportion of patients who experienced any adverse drug reaction events within 28 days after being diagnosed with COVID-19.	up to 28 days
Secondary	thromboembolic event rates	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.	up to 28 days