NCT05792865

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
488

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 28, 2023

Last Update Submit

March 28, 2023

Conditions

COVID-19

Keywords

Hospitalizedpaxlovid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • all-cause deaths rates

    up to 28 days

  • rehospitalization event rates

    up to 28 days

  • COVID-19 repositive event rates

    up to 28 days

  • adverse drug reaction event

    up to 28 days

  • thromboembolic event rates

    up to 28 days

Study Arms (3)

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

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

No paxlovid used

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

Drug: No paxlovid

Interventions

PaxlovidDRUG

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.

Also known as: paxlovid within initial 5 days
Paxlovid（Within 5 days after the diagnosis of COVID-19）
No paxlovidDRUG

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.

No paxlovid used

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Confirmed diagnosis of COVID-19 infection.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual specimen, plasma, 1 ml. Each specimen will be uniquely identified to ensure that patient privacy is not compromised.

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Zhang, PhD

CONTACT

+86 01085231464jeffzhang1619@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professer

Study Record Dates

First Submitted

March 28, 2023

First Posted

March 31, 2023

Study Start

March 30, 2023

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share