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

Conditions

• COVID-19 SARS-CoV-2 Infection

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ibuzatrelvir — DRUG
  ibuzatrelvir tablets
• placebo — DRUG
  placebo tablets

Study Details

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Key Dates

Start date

Dec 8, 2024

Status verified

Jun 2026

Primary completion

Oct 3, 2027

Completion

Mar 2, 2028

Study Design

Enrollment

2,330 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ibuzatrelvir
  Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.
• Placebo Comparator: placebo
  placebo administered orally every 12 hours (twice daily) for 5 days.

Primary Outcome Measure

Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality [ Time Frame: Day 1 through Day 28 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (84)

Find similar trials in Little Rock, AR