Observing the safety and effectiveness of Paxlovid in patients at high risk for severe COVID-19
Official title: POST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFECTIVENESS OF PAXLOVID IN PATIENTS, AND WHO ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19
Run by Pfizer · NCT05890612 · Data updated 2026-11-12
This study is testing how safe and effective Paxlovid is for people in Korea who are at high risk of getting severe COVID-19 and have mild-to-moderate symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | November 29, 2023 |
| Main results expected | February 17, 2029 |
| Study ends | February 17, 2029 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT05890612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with mild-to-moderate COVID-19 symptoms who are at high risk for severe outcomes and have consented to participate.
✕Probably not a fit
Patients with contraindications to Paxlovid or those receiving investigational medicines during the observation period may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the real-world safety and effectiveness of Paxlovid in patients in Korea who are at high risk of developing severe COVID-19. It focuses on individuals with mild-to-moderate symptoms who have received or are set to receive Paxlovid as per local guidelines. Participants will be monitored for 28 days following their last treatment to assess outcomes without any scheduled visits, reflecting routine medical practice.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of Paxlovid, potentially improving treatment strategies for high-risk COVID-19 patients.
How similar studies have gone: Other studies have shown positive outcomes with Paxlovid in clinical settings, suggesting that this observational approach could yield valuable data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Pfizer Korea
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.