Ibuzatrelvir's Phase 3 Trial in COVID-19 SARS-CoV-2 Infection Reads Out
ESTIMÉCONFIANCE 50 %ClinicalTrials.gov[1] lists 2027-10-03 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Pfizer's phase 3 trial of Ibuzatrelvir in covid-19 sars-cov-2 infection reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,330 participants. 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.
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