A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19.

Eligibility criteria

Qualifiers

18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention.

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.

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);

Disqualifiers

Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19.

Receiving dialysis or have current kidney failure (ie, eGFR consistently <15 mL/min/1.73 m2)

Active liver disease

History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator

Trial design

Treatments tested in this trial

  • ibuzatrelvir
  • remdesivir
  • placebo for ibuzatrelvir
  • placebo for remdesivir

Treatment groups

300 Participants
are divided into 3 treatment groups

Locations

148
Argentina
Hospital Italiano de La PlataB1900XI, La PlataBuenos Aires, Argentina
Hospital Italiano de Buenos AiresC1199ABB, ABBBuenos Aires F.D., Argentina
Instituto Médico Río CuartoX5800AEV, Río CuartoCórdoba Province, Argentina
Sanatorio Sagrado Corazón1039, Buenos Aires Argentina

Sponsors and collaborators

Pfizer

Lead sponsor