A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
{ "Study of Ibuzatrelvir for Non-Hospitalized COVID-19 Patients at High Risk", "This study is looking into a medicine called ibuzatrelvir for adults and teenagers with COVID-19 who are not in the hospital but are at higher risk of getting very sick. The main goal is to see if ibuzatrelvir is safe and works to prevent emergency room visits, hospital stays, or death related to COVID-19 within 28 days. You could join if you are 12 years or older, have COVID-19, and have certain risk factors for severe disease. Participants will randomly receive either ibuzatrelvir or a placebo (an inactive pill) by mouth for 5 days. The study will last about 6 months for each participant.", "design": "This is an interventional study where participants are randomly assigned to receive either ibuzatrelvir or a placebo. It plans to enroll 2330 participants.", "commitments": "You would take ibuzatrelvir or placebo tablets by mouth for 5 days. The total study duration for you would be around 6 months.", "compensation": "Not stated in the trial record.", "follow_up": "The study will track COVID-19 related emergency department visits, hospitalizations, and deaths from Day 1 through Day 28 after starting treatment.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
At a glance
Conditions
Where it's being run
252 sites across 114 statesStudy leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortalityDay 1 through Day 28
The difference in proportions of patients requiring COVID 19 related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.