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Trial · NCT04447469

Outcomes12

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYCohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29Day 29
Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).
percentage of participantsNUMBER
PRIMARYCohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29Day 29Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.percentage of participantsNUMBER
PRIMARYCohort 2, Phase 2: Percentage of Participants Who Died by Day 29Day 29
Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).
percentage of participantsNUMBER
PRIMARYCohort 2, Phase 3: Percentage of Participants Who Died by Day 29Day 29Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.percentage of participantsNUMBER
SECONDARYCohort 1, Phase 2: Time to 2-point Clinical Improvement by Day 29Day 29
Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).
daysMEDIAN
SECONDARYPhase 2, Cohort 1: Time to Return to Room Air or Discharge by Day 29Day 29
Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).
daysMEDIAN
SECONDARYPhase 2, Cohort 1: Percentage of Participants Who Die by Day 29Day 29
Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).
percentage of participantsNUMBER
SECONDARYPhase 2, Cohort 2: Time to 1-Point Clinical Improvement by Day 29Day 29Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug.daysMEDIAN
SECONDARYPhase 3, Cohort 1: Percentage of Participants Who Died at Day 29Day 29Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.percentage of participantsNUMBER
SECONDARYPhase 3, Cohort 1: Ventilation-Free Survival (Time to Ventilation or Death) by Day 29Day 29Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.daysMEDIAN
SECONDARYPhase 3, Cohort 1: Overall Survival by Day 29Day 29Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.daysMEDIAN
SECONDARYPhase 3, Cohort 2: Time to 1-point Clinical Improvement by Day 29Day 29Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.daysMEDIAN

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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