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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
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 253 → 256 locations
  2. Study sites: 252 to 253 Show 4 more changesShow less
    • Primary completion date: Oct 3, 2027 to Oct 1, 2027
    • Study completion date: Mar 2, 2028 to Feb 12, 2028
    • Eligibility criteria shortened, about 18 words
    • Secondary endpoints: details revised at 10 of 19 entries
  3. Study sites: 253 to 252v45
  4. Trial sites expanded: 248 → 253 locationsv44
  5. Study sites: 247 to 248v43
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 246 to 247v42
  2. Study sites: 244 to 246v41
  3. Study sites: 246 to 244v40
  4. Study sites: 245 to 246v39
  5. Study sites: 243 to 245v38
  1. Trial sites expanded: 103 → 243 locationsv37
  2. Trial sites reduced: 237 → 103 locationsv36
  3. Study sites: 236 to 237v35
  4. Study sites: 234 to 236v34
  5. Primary completion date: Dec 6, 2026 to Oct 3, 2027
    • Study sites: 235 to 234
    • Study completion date: May 6, 2027 to Mar 2, 2028
    v33
  6. Study sites: 231 to 235v32
  7. Study sites revised (231)v31
  8. Study sites: 225 to 231v30
  9. Study sites: 224 to 225v29
  10. Study sites: 220 to 224v28
  11. Study sites: 214 to 220
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (19)
    v27
  12. Study sites: 210 to 214v26
  13. Study sites: 206 to 210v25
  14. Study sites: 199 to 206v24
  15. Study sites: 196 to 199v23
  16. Study sites: 193 to 196v22
  17. Study sites: 186 to 193v21
  18. Study sites: 175 to 186v20
  19. Study sites: 167 to 175v19
  20. Study sites: 161 to 167v18
  21. Study sites: 156 to 161v17
  22. Study sites: 144 to 156v16
  23. Study sites: 139 to 144v15
  24. Study sites: 122 to 139v14
  25. Study sites: 107 to 122v13
  26. Study sites: 90 to 107v12
  27. Study sites: 84 to 90v11
  28. Re-verified, no change to tracked fieldsv10
  29. Study sites: 80 to 84v9
  30. Study sites: 65 to 80v8
  31. Study sites: 53 to 65
    • Primary completion date: Nov 26, 2026 to Dec 6, 2026
    • Study completion date: Apr 26, 2027 to May 6, 2027
    v7
  32. Study sites: 49 to 53v6
  33. Study sites: 48 to 49v5
  34. Study sites: 5 to 48
    • Primary completion date: Nov 17, 2026 to Nov 26, 2026
    • Study completion date: Apr 17, 2027 to Apr 26, 2027
    v4
  35. Re-verified, no change to tracked fieldsv3
  36. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 5
    • Primary completion date: Nov 24, 2026 to Nov 17, 2026
    • Study completion date: Apr 23, 2027 to Apr 17, 2027
    • Start date changed from estimate of Dec 16, 2024 to Dec 8, 2024
  37. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
436 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
(from sponsor)		 COVID-19 SARS-CoV-2 Infection
Related terms Coronaviridae Infections, Coronavirus Infections, COVID-19, Infections, Lung Diseases, Nidovirales Infections, Pneumonia, Pneumonia, Viral, Respiratory Tract Diseases, Respiratory Tract Infections, RNA Virus Infections, Virus Diseases
Enrollment 2,330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov