Ibuzatrelvir alone or with remdesivir for severely immunocompromised adults with COVID-19

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blinded, double-dummy, phase 3 trial that compares three arms: remdesivir IV alone, oral ibuzatrelvir alone, and the combination of ibuzatrelvir with remdesivir. Eligible adults are severely immunocompromised, have a confirmed SARS‑CoV‑2 infection, and developed symptoms within five days; participants may be non‑hospitalized or hospitalized only for observation or to receive the intervention and must not require supplemental oxygen. Ibuzatrelvir is taken orally twice daily while remdesivir is administered as a daily IV infusion, with matching placebos used to maintain blinding. The study tests both efficacy and safety outcomes to see if the oral drug, alone or with remdesivir, reduces progression or persistence of symptomatic COVID‑19 in this high‑risk group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19
2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.
3. Severely immunocompromised due to:

   * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;
   * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);
   * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;
   * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.

Exclusion Criteria:

1. Severe or critical COVID-19, or current need for supplemental oxygen.
2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min)
3. Active liver disease
4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
7. 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.
8. Has received any other antiviral for the treatment of the current COVID-19 infection
9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
11. Prior participation in this trial or any clinical trial of ibuzatrelvir.
12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
13. 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 it's running

• Hope Clinical Research, Inc.
  Canoga Park, California, United States Recruiting
• Amicis Research Center - Granada Hills
  Granada Hills, California, United States Recruiting
• Jacobs Medical Center at UC San Diego Health
  La Jolla, California, United States Recruiting
• UC Davis CTSC Clinical Research Center
  Sacramento, California, United States Recruiting
• University of California Davis Health
  Sacramento, California, United States Recruiting
• UC San Diego Medical Center - Hillcrest
  San Diego, California, United States Recruiting

+109 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.