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Trial · NCT04978051

Registered outcomes20

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

ListOutcomeTime frameDescription
PrimaryEfficacy of experimental treatmentup to 10 days
Number of patients reaching grade 2 (inpatient, no longer requiring supplemental oxygen and no longer requiring care or grade 1 (hospital discharge) of the ordinal scale of the clinical state of the patient for 48 hours.
PrimarySafety of experimental treatmentup to 10 daysNumber of patients without an adverse reaction scoring 3, 4 or 5 according to the Criteria of Adverse Event Terminology (CTC-AE).
SecondaryLong-term efficacyup to 10 daysNumber (percentage) of patients who reach grade 2 or grade 1 during the 10 days of to have initiated treatment.
SecondaryTime to achive a clinical responseup to 40 days
period time (days) between visit 1 (treatment start visit) and the day of gathering sustained 48-hour grade 2, grade 1 or grade 0 classification on the WHO 8-point ordinal scale for clinical status assessment The patient must be discharged from the hospital by the 28th day without a relapse or comorbidity related to COVID-19
SecondaryTime to achive an afebrile stateup to 40 daysperiod time (days) to reach a 48-hour sustained afebrile state (i.e., body temperature ≤ 37.5ºC) without antipyretic medication.
Secondarytime from symptom onset to treatmentup to day 1period time (days) between the first COVID-19-related symptom and visit 1 (treatment start visit).
SecondaryRespondersup to 40 daysNumber (percentage) of patients considered as responders based on National Early Warning Score 2 (NEWS 2)
SecondaryCOVID-19 related relapseup to 40 daysnumber (and percentage) of patients discharged who presents any COVID-19-related relapse or comorbidity
SecondaryPatients with Adverse Eventsup to 40 daysnumber of patients with Any Adverse Events
SecondaryAdverse Eventsup to 40 daysNumber of Adverse Events
SecondarySerious Adverse Eventsup to 40 daysNumber of Serious Adverse Events
SecondaryOverall mortalityup to 40 daysnumber of patients who died
SecondaryCOVID-19 related mortalityup to 40 daysnumber of patients who died due to COVID-19
SecondaryTime until deathup to 40 daysnumber of days from visit 1 until death
SecondaryCOVID-19-related complicationsup to 40 daysnumber of patients who had any COVID-19 related complications
SecondaryPatients requiring intensive careup to 40 daysnumber of patients who require intensive care
Secondarypatients requiring intensive care and invasive mechanical ventilationup to 40 daysnumber of patients who require intensive care and invasive mechanical ventilation
Secondarypatients requiring oxygen supplementationup to 40 daysnumber of patients who require oxygen supplementation from hospital discharge up until visit 7
SecondaryPatients with nonsocomial infectionup to 40 daysnumber (and percentage) of patients diagnosed with another nosocomial infection
SecondaryRehospitalizationsup to 40 daysnumber (and percentage) of patients who requires hospital readmission within 28 (± 3) days from hospital discharge

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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