Pfizer Launches Phase III Clinical Trial of Ibuzatrelvir for Outpatient Treatment of High-Risk COVID-19

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a Phase III, double-blind, two-arm, interventional study has been initiated by Pfizer Inc./Pfizer (China) Research and Development Co., Ltd. to investigate the efficacy and safety of IBUZATRELVIR oral administration compared to placebo in non-hospitalized symptomatic COVID-19 adult and adolescent participants at high risk of progression to severe disease. The clinical trial registration number is CTR20253143, with the initial information disclosure date on August 11, 2025.

The drug formulation is tablets, administered orally at a dose of 600 mg BID (twice daily) for 5 days. The primary objective of this trial is to evaluate the efficacy and safety of Ibuzatrelvir in treating non-hospitalized symptomatic COVID-19 adult and adolescent participants with a high risk of progression to severe disease.

Ibuzatrelvir is a chemical drug indicated for Coronavirus Disease 2019 (COVID-19). COVID-19 is an infectious disease caused by the novel coronavirus, with common symptoms including fever, dry cough, and fatigue. Some patients may experience nasal congestion and runny nose. Diagnosis is made through nucleic acid testing, and due to its high transmissibility, isolation and treatment are required.

The primary endpoint indicators of this trial include the proportion of study participants who, by Day 28, visited the emergency department for COVID-19-related issues and received oxygen support, COVID-19 antiviral or IV treatments (e.g., fluid resuscitation, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause mortality; secondary endpoint indicators include the time (in days) until all target symptoms resolved by Day 28, the proportion of study participants experiencing cardiovascular, renal, and pulmonary events (CRPE) from Day 1 to Week 24, among other metrics.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 150 participants in China and 2,330 participants internationally. Internationally, 133 participants have been enrolled.

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