A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05387369

Enrollment

2000

Registered

2022-05-24

Start date

2022-03-21

Completion date

2027-03-30

Last updated

2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

paxlovid

Brief summary

The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.

Detailed description

The study is a real-world study and the case records of patients with COVID-19 who visit Huashan Hospital affiliated to Fudan University from 2022 to 2027 and receive Paxlovid therapy will be collected in this study. The medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of COVID-19.

Interventions

DRUGPaxlovid

The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants who have a positive SARS-CoV-2 test result; * Participants who have one or more mild or moderate COVID-19 symptoms.

Exclusion criteria

* No specific

Design outcomes

Primary

Measure	Time frame	Description
Viral shedding time	up to 28 days	time from the first positive testing to the first day of nucleic acid Ct value\> 35 for both ORF1ab and N gene (in two consecutive).
Percentage of the participants who have progression of COVID-19	up to 28 days	Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause

Secondary

Measure	Time frame	Description
AEs and SAEs through Day 28	up to 28 days	Adverse events and Serious adverse events through Day 28
Percentage of participants who turned negative for SARS-CoV-2	up to 28 days	Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14
Time to sustained clinical recovery	up to 28 days	Time to sustained clinical recovery

Countries

China

Contacts

Primary ContactFeng Sun, MD

aaronsf1125@126.com+86 02152889999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026