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Trial · NCT04382586

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Respiratory Failure-free SurvivalUp to Day 28Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28
PrimaryTime to Breathing Room AirUp to 7 months
Time to return to breathing room air is defined as the time from randomization date to the earliest time where the participant is stable on room air without supplemental oxygen. Total follow-up time in days is the total time of all participants from the randomization date to the first event date or Day 28 if there is no event. The rate was calculated as total number of events in which a participant returned to breathing room air on or before Day 28 divided by the total follow-up time in days.
SecondaryNumber of Participants Experiencing Respiratory Failure or DeathUp to Day 28Number of participants experiencing respiratory failure or death on or before Day 28
SecondaryNumber of Participants With All-cause MortalityUp to Day 28Number of participants with all-cause mortality on or before Day 28
SecondaryNumber of Participants Discharged AliveUp to Day 28Number of participants discharged alive on or before Day 28
SecondaryNumber of Participants Discharged Alive From the ICUUp to Day 28Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
SecondaryNumber of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal ScaleUp to Day 28
Number of participants with improvement in WHO 8-point-scale, in which improvement was considered a score that changed from ≥4 at baseline to ≤ 3 at Day 28 as assessed by the investigator. Scoring ranges from 0 = uninfected with no clinical or virologic evidence of disease to 8 = dead.
SecondaryDuration of Mechanical VentilationUp to Day 28Number of days on mechanical ventilation on or before Day 28
SecondaryDuration of HospitalizationUp to Day 28Number of days hospitalized on or before Day 28
SecondaryPaO2:FiO2 RatioBaseline, Day 7, Day 14, Day 21 and Day 28Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
SecondaryNumber of Participants With Adverse EventsUp to 7 monthsNumber of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), and TEAEs grade 3 or higher, including laboratory findings

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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