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Trial · NCT04333472

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimaryProportion of subjects alive and free of respiratory failure29 daysProportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29
PrimaryProportion of subjects discharged home alive29 daysProportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29
PrimaryTreatment-emergent adverse events (AEs)29 daysProportion of patients experiencing AEs
SecondaryClinical status29 days
• Clinical status at Day 29 on NIAID 8-point ordinal scale (NIH 2020): 1. Not hospitalized, no limitations 2. Not hospitalized, with limitations 3. Hospitalized, no active medical problems 4. Hospitalized, not on oxygen 5. Hospitalized, on oxygen 6. Hospitalized, on high-flow oxygen or noninvasive mechanical ventilation 7. Hospitalized, on mechanical ventilation or ECMO 8. Death
SecondaryTime to improvement29 daysTime (days) to improvement of 2 points on 7-point ordinal clinical scale
SecondaryIncidence of mechanical ventilation29 daysProportion of patients who require mechanical ventilation
SecondaryVentilator-free days29 daysVentilator-free days to Day 29
SecondaryIncidence of Intensive Care Unit (ICU) admission29 daysProportion of patients who require ICU admission
SecondaryDuration of ICU stay29 daysDuration (days) of ICU stay
SecondaryTime to hospital discharge29 daysTime (days) to hospital discharge
SecondaryDuration of need for supplemental oxygen29 daysDuration (days) of need for supplemental oxygen
SecondaryTime to virus negativity29 daysTime (days) to virus negativity by RT-PCR, defined as absence of SARS CoV 2 on 2 consecutive days of sampling
SecondarySARS-CoV-2 viral load29 daysSARS-CoV-2 viral load (number of copies) by quantitative RT-PCR
SecondaryAEs leading to withdrawal29 daysProportion of patients experiencing AEs leading to early discontinuation of trial treatment
SecondaryTreatment-emergent serious AEs (SAEs)29 daysProportion of patients experiencing SAEs
SecondaryTreatment-emergent abnormalities in clinical laboratory parameters or electrocardiograms (ECGs)29 daysProportion of patients experiencing treatment-emergent changes in clinical laboratory parameters or ECGs
SecondaryIncidence of meeting safety-related stopping rules29 daysProportion of patients who meet study safety-related stopping rules
SecondaryPharmacokinetics of piclidenoson in this patient population5 daysPlasma concentrations over time of piclidenoson
SecondarySerum cytokine levels29 daysChange from baseline in serum concentrations of cytokines

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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