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Trial · NCT02057757

Registered outcomes22

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

ListOutcomeTime frameDescription
PrimaryTime to Hospital DischargeMeasured through Day 28The time to hospital discharge measured through Day 28.
SecondaryNumber of Participants Hospitalized on Days 3, 7, 14, and 28Measured at Day 3, Day 7, Day 14, and Day 28The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.
SecondaryNumber of Participants Who Died Within the First 5 DaysMeasured within First 5 DaysTotal Deaths of Participants, including Deaths within First 5 Days
SecondaryNumber of Participants Who Experienced Clinical SymptomsMeasured through Day 28Measured daily through Study Day 14 and then again on Study Day 28
SecondaryDuration of Fever in Study ParticipantsMeasured each day through Day 14 and on Day 28
Study participants' duration (hours) of fever measured daily through Day 14 and then again on Day 28. The total duration in hours from the visit when fever was registered for the study participant until the next visit when no fever was registered for the study participant.
SecondaryNumber of Participants Who Require Oxygen UseMeasured through Day 28 or participants' last day of hospitalizationNumber of study participants who require use of supplemental oxygen at time points (e.g., Any time, Day 0, Day 3, Day 7, Day 14, and Day 28)
SecondaryNumber of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28)Measured through Day 28 or participants' last day in the ICUNumber of study participants (e.g., adult and children) admitted to the intensive care unit (ICU) by time point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.
SecondaryStudy Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28)Measured through Day 28 or participants' last day of hospitalizationStudy participants (e.g., adults, children) requiring mechanical ventilation (e.g., intubation/extubation) at study time points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.
Secondary
Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study
Measured through Day 28 or participants' last day of hospitalization
Number of study participants (e.g., adults and children) with the presence of a complication (pneumonia, respiratory failure requiring mechanical ventilation, acute respiratory distress syndrome \[ARDS\], sepsis, or bronchiolitis) during the study .
SecondaryDuration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)Measured daily through Day 14 and on Day 28Study participant (e.g., adults and children) answers (e.g., yes) to global assessment questions measured daily through Day 14 and then again on Day 28.
SecondaryNumber of Participants Using Antibiotics/Antivirals During HospitalizationMeasured through participants' first 5 days of hospitalizationNumber of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.
SecondaryNumber of Participants Who Are Re-hospitalized Within 28 DaysMeasured through Day 28Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).
SecondaryUse of Systemic CorticosteroidsMeasured within First 5 DaysNumber of study participants taking Systemic Steroids during first 5 days.
SecondaryPresence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)Measured through Day 3Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.
SecondaryNumber of Participants Reporting Adverse Events (AEs)Measured through Day 28 or participants' last day of hospitalizationNumber of study participants with at least one Adverse Event During Study Duration
SecondaryNumber of Participants Reporting Serious Adverse Events (SAEs)Measured through Day 28 or participants' last day of hospitalizationNumber of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).
SecondaryChemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28Measured on Day 3, Day, 7 and Day 28Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.
SecondaryChemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28Measured on Day 3, Day 7, and Day 28Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.
SecondaryChemistry Laboratory Assessment (CRP) on Days 3, 7, and 28Measured on Day 3, Day, 7 and Day 28Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.
SecondaryHematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28Measured on Day 3, Day, 7 and Day 28Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.

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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