A Registry Study of Patients Hospitalized With Confirmed COVID-19

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: paxlovid; Drug: Paxlovid; Drug: No paxlovid

• Study Type: Observational
• Enrollment (Anticipated): 488

Contacts and Locations

• Study Contact: Name: Yi Zhang, PhD; Phone Number: +86 01085231464; Email: jeffzhang1619@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will focus on COVID-19 infected patients who are admitted to the Beijing Chaoyang Hospital, affiliated with Capital Medical University, from November 15th, 2022 to March 30th, 2023.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Paxlovid（Within 5 days after the diagnosis of COVID-19）; According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID is within 5 days.	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.; Other Names: paxlovid within initial 5 days
Paxlovid （More than 5 days after the diagnosis of COVID-19）; According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID exceeds 5 days.	Drug: Paxlovid; Patients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group.; Other Names: Paxlovid outside of the initial 5 days
No paxlovid used; Patients have never used Paxlovid after being diagnosed with COVID-19, whether before or after hospitalization.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Principal Investigator: Yi Zhang, PhD, Beijing Chao Yang Hospital; Principal Investigator: Zhuoling An, PhD, Beijing Chao Yang Hospital; Principal Investigator: Chaohui Tong, PhD, Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hospitalized; paxlovid
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CYH-PHARM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No