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Trial · NCT04590586

Outcomes33

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYLanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29
Day 1 (the day of the first dose of study drug for randomized participants who received at least one dose of study drug or the day of randomization for randomized participants who did not receive any study drug) to Day 29
The lanadelumab sub-protocol primary analysis set includes all participants who were randomized to lanadelumab as well as all participants who were randomized to any placebo arm included in the control arm for lanadelumab with a baseline clinical severity status of Grade 3 to Grade 5 on the clinical severity status 8-point ordinal scale.
daysMEDIAN
PRIMARYApremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29
Day 1 (the day of the first dose of study drug for randomized participants who received at least one dose of study drug or the day of randomization for randomized participants who did not receive any study drug) to Day 29
The apremilast full analysis set (FAS) includes all participants who were randomized to the apremilast arm as well as all participants who were randomized to any placebo arm included in the control arm for apremilast.
daysMEDIAN
PRIMARYZilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29
Day 1 (the day of the first dose of study drug for randomized participants who received at least one dose of study drug or the day of randomization for randomized participants who did not receive any study drug) to Day 29
The zilucoplan full analysis set includes all participants who were randomized to the zilucoplan arm as well as all participants who were randomized to any placebo arm included in the control arm for zilucoplan.
daysMEDIAN
SECONDARYLanadelumab Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29Day 29Lanadelumab sub-protocol primary analysis setpercentage of participantsNUMBER
SECONDARYLanadelumab Sub-protocol: Percentage of Participants With a ≥ 2-point Improvement From Baseline or Fit for Discharge on the Clinical Severity Status 8-Point Ordinal Scale at Day 29Baseline (Day 1) and Day 29Lanadelumab sub-protocol primary analysis setpercentage of participantsNUMBER
SECONDARYLanadelumab Sub-protocol: Percentage of Participants Who Died Before or on Day 29Day 1 to Day 29Lanadelumab sub-protocol primary analysis setpercentage of participantsNUMBER
SECONDARYLanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29Day 8, Day 15, and Day 29Lanadelumab sub-protocol primary analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYLanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29Day 2 to Day 29Lanadelumab sub-protocol primary analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYLanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29Day 1 to Day 29Lanadelumab sub-protocol primary analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYLanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29Day 1 to Day 29Lanadelumab sub-protocol primary analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYLanadelumab Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery by Days 8, 15, and 29Day 8, Day 15, and Day 29Lanadelumab sub-protocol primary analysis setpercentage of participantsNUMBER
SECONDARYLanadelumab Sub-protocol: Percentage of Participants Who Achieved Sustained Clinical RecoveryDay 60Lanadelumab sub-protocol primary analysis setpercentage of participantsNUMBER
SECONDARYLanadelumab Sub-protocol: Number of Participants With Treatment-emergent Adverse Events (TEAEs)From first dose of study drug to end of study (Day 60)Lanadelumab safety analysis set included all participants in the lanadelumab FAS who received at least one dose of study drug.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYApremilast Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29Day 29Apremilast sub-protocol full analysis setpercentage of participantsNUMBER
SECONDARYApremilast Sub-protocol: Percentage of Participants With a ≥ 2-point Improvement From Baseline or Fit for Discharge on the Clinical Severity Status 8-Point Ordinal Scale at Day 29Baseline (Day 1) and Day 29Apremilast sub-protocol full analysis setpercentage of participantsNUMBER
SECONDARYApremilast Sub-protocol: Percentage of Participants Who Died Before or on Day 29Day 1 to Day 29Apremilast sub-protocol full analysis setpercentage of participantsNUMBER
SECONDARYApremilast Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29Day 8, Day 15, and Day 29Apremilast sub-protocol full analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYApremilast Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-Point Ordinal Scale From Baseline to Day 29Day 2 to Day 29Apremilast sub-protocol full analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYApremilast Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29Day 1 to Day 29Apremilast sub-protocol full analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYApremilast Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29Day 1 to Day 29Apremilast sub-protocol full analysis setParticipantsCOUNT_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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