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Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)

Study acronym: RECOVER
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Apr 1, 2029 → Jul 1, 2029
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 13% 237 → 206 participants
See other at-risk trials from Royal College of Surgeons, Ireland

Record History

  1. Primary endpoint(s) modified Primary completion pushed from Apr 1, 2029 to Jul 1, 2029 · Enrollment reduced: 237 → 206 participants · Interventions modified · 5 morev7 Show 8 more changesShow less
    • Primary completion pushed from Apr 1, 2029 to Jul 1, 2029
    • Enrollment reduced: 237 → 206 participants
    • Interventions modified
    • Eligibility criteria shortened, about 161 words
    • Secondary endpoints: 5 to 24
    • Site details revised at 1 of 7 sites
    • Collaborators revised (11)
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Dec 1, 2023 to Apr 1, 2029 Completion date: Jul 1, 2024 to Jul 1, 2029 · Collaborators revised (11)v6 Show 2 more changesShow less
    • Completion date: Jul 1, 2024 to Jul 1, 2029
    • Collaborators revised (11)

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 7 of 7 sitesv5 Show 1 more changeShow less
    • Site details revised at 7 of 7 sites
  4. Site details revised at 3 of 7 sites Collaborators: 9 to 11v4 Show 1 more changeShow less
    • Collaborators: 9 to 11

    See this version in full on ClinicalTrials.gov ↗

  5. Phase: Not specified to Phase 4 Primary endpoints: 6 to 1 · Study sites: 8 to 7 · Interventions: Kaftrio (Drug) · 3 morev3 Show 6 more changesShow less
    • Primary endpoints: 6 to 1
    • Study sites: 8 to 7
    • Interventions: Kaftrio (Drug)
    • Eligibility criteria expanded, about 363 words
    • Secondary endpoints expanded, about 109 words
    • Study description expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study description expanded, about 12 wordsv2 See this version in full on ClinicalTrials.gov ↗
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
RECOVER is a prospective, multicenter observational study designed to measure the real world clinical effectiveness of elexacaftor/tezacaftor/ivacaftor (ETI) triple combination therapy in people with cystic fibrosis initially over a two year period, followed by a five year extension period. Measured outcomes include measures of lung function, lung inflammation, lung imaging, abdominal symptoms, gut inflammation, liver function, pancreatic exocrine function, nasal inflammation, quality of life and adherence to therapy. The study will examine outcomes in two cohorts, children aged six to eleven years and children and adults aged twelve and above.
Trial Details
NCT Number NCT04602468
Lead Sponsor Royal College of Surgeons, Ireland
Collaborators: Imperial College London, University College Dublin, University of Limerick, Cystic Fibrosis Registry of Ireland, Erasmus Medical Center, Medizinische Hochschule Brandenburg Theodor Fontane, Teagasc, The Hospital for Sick Children, St. James's Hospital, Ireland, Amsterdam UMC, Children's Health Ireland
Conditions Cystic Fibrosis, Cystic Fibrosis Liver Disease, Cystic Fibrosis in Children, Adherence, Medication, Cystic Fibrosis Gastrointestinal Disease
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov