NCT05890612

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress48%
Nov 2023Jul 2029

First Submitted

Initial submission to the registry

June 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

November 29, 2023

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2029

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

5.6 years

First QC Date

June 2, 2023

Last Update Submit

July 22, 2025

Conditions

COVID-19

Keywords

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)PAXLOVIDpost marketing surveillance (PMS)Korea

Outcome Measures

Primary Outcomes (11)

  • Proportion of patients with an adverse event (AE)

    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.

    Baseline through Day 33

  • Proportion of patients with an adverse drug reaction (ADR)

    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.

    Baseline through Day 33

  • Proportion of patients with a serious AE (SAE)

    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.

    Baseline through Day 33

  • Proportion of patients with a serious ADR (SADR)

    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.

    Baseline through Day 33

  • Proportion of patients with an unexpected AE (UAE)

    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.

    Baseline through Day 33

  • Proportion of patients with an unexpected ADR (UADR)

    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.

    Baseline through Day 33

  • Proportion of patients with a serious unexpected AE (SUAE)

    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.

    Baseline through Day 33

  • Proportion of patients with a serious unexpected ADR (SUADR)

    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.

    Baseline through Day 33

  • Proportion of COVID-19-related hospitalization from any cause

    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.

    Baseline through Day 33

  • Proportion of COVID-19-related death from any cause

    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.

    Baseline through Day 33

  • Proportion of subjective assessment of COVID-19-related symptomatic change

    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.

    Day 5, Day 14, Day 33

Study Arms (1)

Participants receiving PAXLOVID

Participants receiving PAXLOVID according to locally approved label.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Korea

Seoul, 04631, South Korea

RECRUITING

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 6, 2023

Study Start

November 29, 2023

Primary Completion (Estimated)

July 13, 2029

Study Completion (Estimated)

July 13, 2029

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

KR(1)