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A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started2024-12-08
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
Study Status, Contacts/Locations v44
Study sites253→252
2026-07-30
Study Status, Contacts/Locations v43
Trial sites expanded: 248 → 253 locations
2026-07-07
Study Status, Contacts/Locations v42
Study sites247→248
2026-06-29
Study Status, Contacts/Locations v41
Study sites246→247
2026-06-15
Study Status, Contacts/Locations v40
Study sites244→246
Show 3 earlier versions
2026-06-04
Study Status, Contacts/Locations v39
Study sites246→244
2026-05-26
Study Status, Contacts/Locations v38
Study sites245→246
2026-05-19
Study Status, Contacts/Locations v37
Study sites243→245
2026-05-12
Study Status, Contacts/Locations v36
Trial sites expanded: 103 → 243 locations
2026-05-04
Study Status, Contacts/Locations v35
Trial sites reduced: 237 → 103 locations
2026-04-15
Study Status, Contacts/Locations v34
Study sites236→237
2026-03-24
Study Status, Contacts/Locations v33
Study sites234→236
2026-03-10
Study Status, Contacts/Locations v32
Primary completion date2026-12-06→2027-10-03
Completion date2027-05-06→2028-03-02
Study sites235→234
2026-03-03
Study Status, Contacts/Locations v31
Study sites231→235
2026-02-03
Study Status, Contacts/Locations v30
Study sites231 entries, revised
InstitutoParadigm MédicoClinical RíoResearch, CuartoLLC
2026-01-29
Study Status, Contacts/Locations v29
Study sites225→231
2026-01-12
Study Status, Contacts/Locations v28
Study sites224→225
2025-12-18
Study Status, Contacts/Locations v27
Study sites220→224
2025-12-03
Study Status, Outcome Measures, Eligibility, Contacts/Locations, References v26
Study sites214→220
Eligibility criteria+102 characters
[...] ed to risk factors. The list of risk factors includes: BMI ≥3035 kg/m2; Current smoker; Chronic lung disease; Cardiovascular [...] onfirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization. Init [...] ng 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] within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula or the Co [...] ys prior to study entry, as determined by the investigator. History of hypersensitivity or other contraindication [...] [...]
Secondary endpoints19 entries, revised
Time to sustained resolution of all COVID-19 targeted symptoms resolution Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal/nasal swabs Time (days) to sustained alleviation of all targeted symptoms through Day 28. Duration of each targeted COVID-19 sign/symptom.
2025-11-17
Study Status, Contacts/Locations v25
Study sites210→214
2025-11-11
Study Status, Contacts/Locations v24
Study sites206→210
2025-10-27
Study Status, Contacts/Locations v23
Study sites199→206
2025-10-17
Study Status, Contacts/Locations v22
Study sites196→199
2025-10-13
Study Status, Contacts/Locations v21
Study sites193→196
2025-10-09
Study Status, Contacts/Locations v20
Study sites186→193
2025-10-01
Study Status, Contacts/Locations v19
Study sites175→186
2025-09-22
Study Status, Contacts/Locations v18
Study sites167→175
2025-09-15
Study Status, Contacts/Locations v17
Study sites161→167
2025-09-08
Study Status, Contacts/Locations v16
Study sites156→161
2025-09-02
Study Status, Contacts/Locations v15
Study sites144→156
2025-08-13
Study Status, Contacts/Locations v14
Study sites139→144
2025-08-04
Study Status, Contacts/Locations v13
Study sites122→139
2025-07-16
Study Status, Contacts/Locations v12
Study sites107→122
2025-07-07
Study Status, Contacts/Locations v11
Study sites90→107
2025-06-23
Study Status, Contacts/Locations v10
Study sites84→90
2025-06-09
Study Status v9
Re-verified, no change to tracked fields
2025-05-30
Study Status, Contacts/Locations v8
Study sites80→84
2025-05-15
Study Status, Contacts/Locations v7
Study sites65→80
2025-04-11
Study Status, Contacts/Locations v6
Primary completion date2026-11-26→2026-12-06
Completion date2027-04-26→2027-05-06
Study sites53→65
2025-02-26
Study Status, Contacts/Locations v5
Study sites49→53
2025-02-18
Study Status, Contacts/Locations v4
Study sites48→49
2025-02-12
Study Status, Eligibility, Contacts/Locations v3
Primary completion date2026-11-17→2026-11-26
Completion date2027-04-17→2027-04-26
Study sites5→48
2025-01-22
Study Status v2
Re-verified, no change to tracked fields
2025-01-02
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-11-24→2026-11-17
Completion date2027-04-23→2027-04-17
Start dateestimated 2024-12-16→confirmed 2024-12-08
Study sites0→5
2024-11-05
Original filing
Pfizer
431 trials monitored
See 32 trials at risk
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
Trial Details
NCT Number NCT06679140
Lead Sponsor Pfizer
Conditions COVID-19 SARS-CoV-2 Infection
Enrollment 2,330 participants
Start Date 2024-12-08
Primary Completion 2027-10-01 (estimated)
Study Completion 2028-02-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-25