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Trial · NCT04414618

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryMeasurement of the Change in Oxygen Requirement From Baseline14 days
Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.
SecondaryMeasurement of Time to the Reduction in Oxygen Requirement.14 daysThe time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.
SecondaryThe Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 1414 daysThe percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.
SecondaryTime to Negative Swabs for SARS-CoV-2 by PCR Post Treatment6 weeksThe time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart.
SecondaryThe Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 1414 daysThe percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart.
SecondaryIntubation and Mechanical Ventilation RequirementsFrom screening phase and every day from day 1 to day 14 of treatmentThe percentage of patients in each arm who require intubation and mechanical ventilation by Day 14
SecondaryEvaluation of the Time to Intubation and Mechanical VentilationFrom screening phase and every day from day 1 to day 14 of treatmentThe time in each arm for the patient to require mechanical ventilation.
SecondaryEvaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14From screening phase and every day from day 1 to day 14 of treatment
The proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature \>38.0 C\[100.4 F\]), who are afebrile (defined as temperature \<37.2C \[99 F\]) at Day 14
SecondaryEvaluation of Mortality 30 Days Post-baseline30 days after day 1 of treatmentThe mortality in each arm 30 days post-baseline.
OtherSafety TEAEs6 weeksThe number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs).
OtherSafety SAEs6 weeksThe number of subjects with serious adverse events (SAEs) in each arm.

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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