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RecruitingNCT05387369Updated May 24, 2022

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

An observational study in COVID-19, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Huashan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2023, 3 years 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,000
Ages
12 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • COVID-19

Browse trials for

Keywords

  • paxlovid
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with COVID-19 who were admitted to Huashan Hospital, Fudan University from 2022 to 2027

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

Exclusion Criteria:

  • No specific exclusion criteria in this real world study.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Paxlovid

    Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy

    Drug: Paxlovid

  • Routine therapy

    Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive routine therapy without paxlovid

Interventions

  • DrugPaxlovid

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

06

What researchers measure

Primary outcomes

  1. Viral shedding time

    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).

    Time frame: up to 28 days

  2. Percentage of the participants who have progression of COVID-19

    Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause

    Time frame: up to 28 days

Secondary outcomes

  1. AEs and SAEs through Day 28

    Adverse events and Serious adverse events through Day 28

    Time frame: up to 28 days

  2. Percentage of participants who turned negative for SARS-CoV-2

    Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14

    Time frame: up to 28 days

  3. Time to sustained clinical recovery

    Time to sustained clinical recovery

    Time frame: up to 28 days

07

Study locations

1 of 1 sites recruiting
  • Huashan Hospital Affiliated to Fudan University
    Shanghai, China
    • Jiming Zhang, M.D. · Contact · jmzhang@vip.126.com · +86 021-52887948
    • Jiming Zhang, PhD · Principal investigator
    • Feng Sun, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05387369
Lead sponsor
Huashan Hospital
Responsible party
Jiming Zhang (Professor, Huashan Hospital) — Principal investigator
First posted
May 24, 2022
Start date
Mar 21, 2022
Primary completion
Mar 30, 2023 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
May 24, 2022

Study contacts

Feng Sun, MD
Contact
aaronsf1125@126.com
+86 02152889999
Feng Sun, MD
principal investigator · Huashan Hospital affliatied to Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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