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

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started2025-07-14
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Trial sites expanded: 152 → 158 locations
2026-08-21
Study Status, Study Description v30
Re-verified, no change to tracked fields
2026-08-20
Study Status, Contacts/Locations v29
Study sites151→152
2026-08-13
Study Status v28
Re-verified, no change to tracked fields
2026-08-06
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v27
Study sites152→151
Eligibility criteria-67 characters
Inclusion Criteria: 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with themild intentto ofmoderate administering the study intervention.COVID-19 Confirmed SARS-CoV-2 infection as determined by RAT (or oth [...] pressive effect is still ongoing. Exclusion Criteria: Severe or critical 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 [...]
Secondary endpoints8 entries, revised
Proportion of participants with COVID-19-related ED visits with administrationmedical of supplemental oxygen, COVID-19 antiviral, or IV treatmentintervention, COVID-19-related hospitalization, or all-cause mortality.
2026-07-29
Study Status, Contacts/Locations v26
Trial sites expanded: 148 → 152 locations
2026-07-07
Study Status, Contacts/Locations v25
Study sitesdetails revised at 8 of 148 sites
2026-06-29
Study Status, Contacts/Locations v24
Study sites147→148
2026-06-15
Study Status, Contacts/Locations v23
Trial sites expanded: 141 → 147 locations
2026-06-04
Study Status, Contacts/Locations v22
Study sites139→141
2026-05-26
Study Status, Contacts/Locations v21
Primary completion pushed: 2026-12-06 → 2027-09-27
Completion pushed: 2027-05-06 → 2028-02-25
Study sites138→139
2026-05-19
Study Status, Contacts/Locations v20
Study sitesdetails revised at 4 of 138 sites
2026-05-14
Study Status, Contacts/Locations v19
Trial sites expanded: 54 → 138 locations
2026-05-04
Study Status, Contacts/Locations v18
Trial sites reduced: 132 → 54 locations
2026-04-23
Study Status, Contacts/Locations v17
Trial sites expanded: 129 → 132 locations
2026-04-09
Study Status, Contacts/Locations v16
Trial sites expanded: 117 → 129 locations
2026-03-03
Study Status, Contacts/Locations v15
Study sites115→117
2026-02-03
Study Status, Contacts/Locations v14
Study sites114→115
2026-01-27
Study Status, Contacts/Locations v13
Study sites109→114
2026-01-12
Study Status, Contacts/Locations v12
Study sites101→109
2025-12-10
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations, References v11
Study sites68→101
Eligibility criteria+207 characters
Inclusion Criteria: 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 ot [...] apy; Active hematologic malignancy (eg, chronic lymphocytic lymphomaleukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia); R [...] are receiving immunosuppressive therapy; Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing. Exclusion Criteria: CurrentSevere COVID-19, or curre [...] [...]
Primary endpoints1 entry, revised
The difference in the proportion of patients meeting the primary composite endpoint, between ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants with the composite endpoint of a) COVID-19-related EDwho visitsare withseverely treatment, COVID-19-related hospitalization, or all-cause mortality, and b) evidence of recurrent or persistent SARS-CoV-2 infectionimmunocompromised
2025-11-11
Study Status, Contacts/Locations v10
Study sites62→68
2025-10-27
Study Status, Contacts/Locations v9
Study sites60→62
2025-10-17
Study Status, Contacts/Locations v8
Study sites52→60
2025-10-09
Study Status, Contacts/Locations v7
Study sites38→52
2025-09-29
Study Status, Outcome Measures, Contacts/Locations v6
Study sites33→38
Primary endpoints1 entry, revised
The difference in the proportion of patientsparticipants meetingwith the primary composite endpoint, betweenof ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants witha) COVID-19-related whoED arevisits severelywith immunocompromisedtreatment, COVID-19-related hospitalization, or all-cause mortality, and b) evidence of recurrent or persistent SARS-CoV-2 infection
2025-09-04
Study Status, Contacts/Locations v5
Study sites26→33
2025-08-07
Study Status, Contacts/Locations v4
Study sites23→26
2025-07-24
Study Status, Contacts/Locations v3
Start dateestimated 2025-07-10→confirmed 2025-07-14
Study sites15→23
2025-07-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites12→15
2025-06-20
Study Status, Contacts/Locations v1
Study sites8→12
2025-06-04
Original filing
Pfizer
431 trials monitored
See 32 trials at risk
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 at baseline with mild-to-moderate COVID-19.
Trial Details
NCT Number NCT07013474
Lead Sponsor Pfizer
Conditions COVID-19 Infection
Enrollment 300 participants
Start Date 2025-07-14
Primary Completion 2027-09-28 (estimated)
Study Completion 2028-02-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-25