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Recruiting

NCT Number: NCT05890612

A Study on Paxlovid Once in the Market, to Observe Its Safety and Effectiveness in Patients Who Have a High Chance of Getting Severe COVID-19

The purpose of this study is to look at the safety and effectiveness of PAXLOVID in the real world and not in clinical studies. The study observes patients who have a high chance of getting severe COVID-19 in Korea.

This study is seeking participants who are:

* Patients with mild-to-moderate COVID-19 symptoms and at high chance of getting severe COVID-19, including hospitalization or death. * Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label. * Patients who have signed informed consent documents after understanding all the important parts of the study.

All participants are treated according to routine medical practice and there are no scheduled visits required by this study. All participants will be studied for a follow-up period of 28 days from the last PAXLOVID treatment to understand the safety and the effectiveness of treatment.

Recruiting

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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

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Korea

Seoul, 04631, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
  • Patients (or a legally acceptable representative) who are willing to provide written informed consent/assent prior to study enrollment.

Exclusion criteria

  • Patients with contraindication according to locally approved label of PAXLOVID.
  • Patients who are going to receive any investigational medicine during the observation period.

Treatment and study plan

Primary outcomes

  1. Proportion of patients with an adverse event (AE)

    Time frame: Baseline through Day 33

    The number of AEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.

  2. Proportion of patients with an adverse drug reaction (ADR)

    Time frame: Baseline through Day 33

    The number of ADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.

  3. Proportion of patients with a serious AE (SAE)

    Time frame: Baseline through Day 33

    The number of SAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.

  4. Proportion of patients with a serious ADR (SADR)

    Time frame: Baseline through Day 33

    The number of SADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.

  5. Proportion of patients with an unexpected AE (UAE)

    Time frame: Baseline through Day 33

    The number of UAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.

  6. Proportion of patients with an unexpected ADR (UADR)

    Time frame: Baseline through Day 33

    The number of UADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.

  7. Proportion of patients with a serious unexpected AE (SUAE)

    Time frame: Baseline through Day 33

    The number of SUAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.

  8. Proportion of patients with a serious unexpected ADR (SUADR)

    Time frame: Baseline through Day 33

    The number of SUADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.

  9. Proportion of COVID-19-related hospitalization from any cause

    Time frame: Baseline through Day 33

    The number and rate of COVID-19-related hospitalizations among all subjects who received the drug and received at least one safety evaluation will be measured.

  10. Proportion of COVID-19-related death from any cause

    Time frame: Baseline through Day 33

    The number and rate of COVID-19-related deaths among all subjects who received the drug and received at least one safety evaluation will be measured.

  11. Proportion of subjective assessment of COVID-19-related symptomatic change

    Time frame: Day 5, Day 14, Day 33

    The rate of subjective assessment change (improve/no change/worsened) compared to the baseline for COVID-19-related overall symptoms of all subjects who received the drug and received at least one safety evaluation will be measured.

Study contacts

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

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Post Marketing Surveillance to Observe Safety and Effectiveness of PAXLOVID in Patients With Positive Results of Viral Testing, and Who Are at High Risk for Progression to Severe COVID-19

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jun 6, 2023
Registry last updated
Jul 24, 2025

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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