A Registry Study of Patients Hospitalized With Confirmed COVID-19

NCT ID: NCT05792865

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

488 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-30

Study Completion Date

2023-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hospitalized paxlovid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

paxlovid

Intervention Type DRUG

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.

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.

Paxlovid

Intervention Type DRUG

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

No paxlovid used

Patients have never used Paxlovid after being diagnosed with COVID-19, whether before or after hospitalization.

No paxlovid

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Paxlovid

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

paxlovid within initial 5 days Paxlovid outside of the initial 5 days

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhang Yi

professer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yi Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Zhuoling An, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Chaohui Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yi Zhang, PhD

Role: CONTACT

Phone: +86 01085231464

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CYH-PHARM1

Identifier Type: -

Identifier Source: org_study_id