Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06703073 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 40 to 41
    • Eligibility criteria expanded, about 142 words
    • Secondary endpoints: details revised at 1 of 19 entries
    v16
  2. Trial sites expanded: 36 → 40 locationsv15
  3. Study sites: 32 to 36v14
  4. Study sites: 30 to 32v13
  5. Study sites: 28 to 30v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Nov 26, 2027 to Jul 2028
    • Study sites: 24 to 28
    • Study completion date: Feb 8, 2028 to Sep 2028
    v11
  2. Study sites: 16 to 24v10
  3. Study sites: 11 to 16v9
  4. Study sites: 8 to 11v8
  5. Start date: Feb 13, 2025 to Jun 10, 2025
    • Study sites: 4 to 8
    v7
  6. Study sites: 3 to 4v6
  7. Study sites: 2 to 3v5
  8. Re-verified, no change to tracked fieldsv4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 17, 2025 to Feb 13, 2025
    • Eligibility criteria shortened, about 3 words
    v3
  10. Start date: Dec 20, 2024 to Feb 17, 2025v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments. This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.
Trial Details
NCT Number NCT06703073
Lead Sponsor PPD Development, LP
Collaborators: Biomedical Advanced Research and Development Authority, InflaRx GmbH, Edesa Biotech Inc., Genentech, Inc.
Conditions
(from sponsor)		 Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome), Acute Respiratory Distress Syndrome
Related terms Acute Lung Injury, Respiratory Distress Syndrome
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov