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Trial · NCT04375397

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Participants Alive and Without Respiratory Failure Through Day 28Through Day 28Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drugpercentage of participantsNUMBER
SECONDARYChange in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14At Day 14Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug; participants with baseline and Day 14 score dataParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMedian Reduction in Days Spent on Supplemental OxygenUp to Day 28Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drugdaysMEDIAN
SECONDARYAll-Cause Mortality at Study Days 7, 14, 21, and 28At Study Days 7, 14, 21, and 28Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drugpercentage of participantsNUMBER
SECONDARYPercentage of Participants Experiencing Respiratory Failure or Death on Study Days 7, 14, 21, and 28At Study Days 7, 14, 21, and 28Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drugpercentage of participantsNUMBER
SECONDARYMechanical Ventilation-Free SurvivalUp to Day 28Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drugdaysMEDIAN
SECONDARYDays on Mechanical VentilationUp to Day 28Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drugdaysMEDIAN
SECONDARYMedian Duration of HospitalizationUp to Day 28Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drugdaysMEDIAN
SECONDARYTime to Discharge From HospitalUp to Day 28Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drugdaysMEDIAN
SECONDARYPartial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) RatioAt Study Days 7, 14, 21, and 28
Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug. Participants with non-missing baseline and at least one post-baseline value are included in the analyses.
mmHgMEAN
SECONDARYOxygenation IndexAt Study Days 7, 14, 21, and 28
Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug. Participants with non-missing baseline and at least one post-baseline value are included in the analyses.
units on a scaleMEAN
SECONDARYNumber of Participants With Adverse EventsFrom first dose of study drug until 30 days following last dose of study drug (up to 70 days)Safety Population: all participants who received at least 1 dose of study drugParticipantsCOUNT_OF_PARTICIPANTS

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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