Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07013474 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 158 to 159
  2. Trial sites expanded: 152 → 158 locations Show 5 more changesShow less
    • Primary completion date: Sep 27, 2027 to Sep 28, 2027
    • Study completion date: Feb 25, 2028 to Feb 5, 2028
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 5 of 8 entries
    • Study description expanded, about 7 words
  3. Re-verified, no change to tracked fieldsv31
  4. Study sites: 151 to 152v30
  5. Re-verified, no change to tracked fieldsv29
  6. Study sites: 152 to 151
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints revised (8)
    v28
  7. Trial sites expanded: 148 → 152 locationsv27
  8. Site details revised at 8 of 148 sitesv26
  9. Study sites: 147 to 148v25
  10. Trial sites expanded: 141 → 147 locationsv24
  11. Study sites: 139 to 141v23
  12. Primary completion pushed from Dec 6, 2026 to Sep 27, 2027
    • Study completion pushed from May 6, 2027 to Feb 25, 2028
    • Study sites: 138 to 139
    v22
  13. Site details revised at 4 of 138 sitesv21
  14. Trial sites expanded: 54 → 138 locationsv20
  15. Trial sites reduced: 132 → 54 locationsv19
  16. Trial sites expanded: 129 → 132 locationsv18
  17. Trial sites expanded: 117 → 129 locationsv17
  18. Study sites: 115 to 117v16
  19. Study sites: 114 to 115v15
  20. Study sites: 109 to 114v14
  21. Study sites: 101 to 109v13
  22. Primary endpoint revised
    • Study sites: 68 to 101
    • Eligibility criteria expanded, about 27 words
    v12
  23. Study sites: 62 to 68v11
  24. Study sites: 60 to 62v10
  25. Study sites: 52 to 60v9
  26. Study sites: 38 to 52v8
  27. Primary endpoint revised
    • Study sites: 33 to 38
    v7
  28. Study sites: 26 to 33v6
  29. Study sites: 23 to 26v5
  30. Study sites: 15 to 23
    • Start date changed from estimate of Jul 10, 2025 to Jul 14, 2025
    v4
  31. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 12 to 15
    v3
  32. Study sites: 8 to 12v2
  33. 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
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
(from sponsor)		 COVID-19 Infection
Related terms Coronavirus Infections, COVID-19, Infections, Lung Diseases, Pneumonia, Pneumonia, Viral, Respiratory Tract Infections, RNA Virus Infections, Virus Diseases
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov