Observing the safety and effectiveness of Paxlovid in patients at high risk for severe COVID-19
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
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 |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05890612 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with contraindications to Paxlovid or those receiving investigational medicines during the observation period may not benefit from this study.
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 performed: Other studies have shown positive outcomes with Paxlovid in clinical settings, suggesting that this observational approach could yield valuable data.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.