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Evaluating ibuzatrelvir for treating non-hospitalized COVID-19 patients at risk for severe disease

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS

PHASE3 · Pfizer · NCT06679140

This study is testing if a new medication called ibuzatrelvir can help adults and teens with COVID-19 who are not in the hospital but are at high risk for getting worse.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment2330 (estimated)
Ages12 Years and up
SexAll
SponsorPfizer (industry)
Locations103 sites (Bakersfield, California and 102 other locations)
Trial IDNCT06679140 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of ibuzatrelvir in adults and adolescents diagnosed with COVID-19 who are not hospitalized but are at high risk for severe disease progression. Participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo for a duration of 5 days, while also allowing for standard care treatments. The overall study will last approximately 6 months, focusing on monitoring outcomes related to COVID-19 severity.

Who should consider this trial

Good fit: Ideal candidates include adults and adolescents aged 12 and older with confirmed COVID-19 and specific risk factors for severe disease.

Not a fit: Patients who are not at risk for severe COVID-19 or those requiring hospitalization may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new oral option for managing COVID-19 in high-risk patients, potentially reducing hospitalizations and severe disease progression.

How similar studies have performed: Other studies have explored antiviral treatments for COVID-19, showing varying degrees of success, but this specific approach with ibuzatrelvir is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 12 to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
2. Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:

   1. 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
   2. 50 to 64 years of age with at least two risk factors;
   3. 65 to 74 years of age with at least one risk factor;
   4. For participants 75 years of age or older, there are no requirements related to risk factors.

   The list of risk factors includes:

   BMI ≥35 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.
3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.
4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir.

Exclusion Criteria:

1. Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \<94% on room air, respiratory rate \>30 breaths/minute, or lung infiltrates \>50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
2. Receiving dialysis or have known severe renal impairment \[ie, eGFR consistently \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents\], using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.
3. Active liver disease with AST or ALT \>3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's syndrome, direct bilirubin \>ULN is exclusionary) within the past 3 months, or liver function impairment with Class C per Child Pugh classification.
4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
5. Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
6. Severely immunocompromised.
7. Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
8. History of hypersensitivity or other contraindication to any of the components of the study interventions.
9. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
10. Current use of any prohibited concomitant medication(s).

10.Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives \[whichever is longer\] prior to screening, or received convalescent COVID-19 plasma within 12 months.

12.Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.

13.Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).

14.Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.

15.Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Where this trial is running

Bakersfield, California and 102 other locations

+53 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: COVID-19 SARS-CoV-2 Infection, Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.