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Trial · NCT04732949

Outcomes18

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTime to Hospital DischargeDay 28The Intent-to-Treat (ITT) analysis population consisted of all randomised patients.daysMEDIAN
PRIMARYTime to RecoveryDay 28The ITT analysis population consisted of all randomised patients.daysMEDIAN
SECONDARYNumber of Patients Who Progressed to Severe Disease or DeathUntil Day 35The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients Who Were Intubated or Who DiedUntil Day 35The ITT analysis population consisted of all randomised patients.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients Who Died Within 35 Days of First DoseUntil Day 35 of first doseThe ITT analysis population consisted of all randomised patients.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYCumulative Number of Patients Who Were Discharged From HospitalDays 7, 14, 21 and 28The ITT analysis population consisted of all randomised patients.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYCumulative Number of Patients With RecoveryDays 7, 14, 21 and 28The ITT analysis population consisted of all randomised patients.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYImprovement Based on Entire WHO OSCI ScoreUntil Day 35ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)Baseline to Day 15The ITT analysis population consisted of all randomised patients.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation PeriodDay 1 until Day 28The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.score on a scaleMEAN
SECONDARYNumber of Patients With Presence of COVID-19 Symptoms Based on Daily AssessmentDay 1 until Day 90The ITT analysis population consisted of all randomised patients.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients With Limitations of Usual Activities Based on Daily AssessmentDay 1 until Day 35The ITT analysis population consisted of all randomised patients.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYQuality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L)Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.score on a scaleMEAN
SECONDARYGeneral Anxiety Disorder 7 Questionnaire (GAD-7) Total ScoreDay 15, Day 28, Day 60 and Day 90The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.score on a scaleMEAN
SECONDARYFunctional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total ScoreDay 15, Day 28, Day 60 and Day 90The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.score on a scaleMEAN
SECONDARYPatient Health Questionnaire-9 (PHQ-9) Total ScoreDay 15, Day 28, Day 60 and Day 90The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.score on a scaleMEAN
SECONDARYOverall Pain Severity as Measured by Brief Pain Inventory Composite ScoresDay 15, Day 28, Day 60 and Day 90The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.score on a scaleMEAN
SECONDARYNumber of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90)The Safety analysis population included all patients in the ITT population who receive at least one dose of study drug.ParticipantsCOUNT_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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