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NCT Number: NCT05387369

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Location status: Recruiting

Location contact

Feng Sun, MD

PRINCIPAL_INVESTIGATOR

Jiming Zhang, M.D.

CONTACT

[email protected]

+86 021-52887948

Jiming Zhang, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria in this real world study.

Treatment and study plan

Paxlovid

Drug

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

Primary outcomes

  1. Viral shedding time

    Time frame: 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).

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

    Time frame: 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 outcomes

  1. AEs and SAEs through Day 28

    Time frame: up to 28 days

    Adverse events and Serious adverse events through Day 28

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

    Time frame: up to 28 days

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

  3. Time to sustained clinical recovery

    Time frame: up to 28 days

    Time to sustained clinical recovery

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Sun, MD

CONTACT

[email protected]

+86 02152889999

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
May 24, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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