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Trial · NCT04967430

Registered outcomes30

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

ListOutcomeTime frameDescription
PrimaryCOVID-19 related urgent care visit, emergency room assessment, hospitalization or death by Day 28 (Primary efficacy endpoint)At day 28Proportion with COVID-19-related emergency room assessment, hospitalization, or death by Day 28
PrimarySARS-CoV-2 RNA negativity (Primary virological endpoint)Day 0 to Day 28The time to SARS-CoV-2 RNA negativity.
PrimaryTreatment-emergent and treatment-related serious adverse events (Primary safety endpoint)Day 0 to Day 28The rate of treatment-emergent and treatment-related serious adverse events (SAEs) by Day 28.
SecondaryRespiratory symptom resolution (Clinical Outcome #1)Day 0 to Day 28Time to resolution of respiratory symptoms.
SecondaryHospitalization (Clinical outcome #2)Day 0 to Day 28Hospitalization for any cause
SecondaryDeath (Clinical outcome #3)Day 0 to Day 28Death due to respiratory or cardiovascular causes
SecondaryAll symptom resolution (Clinical outcome #4)Day 0 to Day 28Time to resolution of all symptoms (return to usual state of heath).
SecondaryOxygen saturation on room air (Clinical outcome #5)Day 0 to Day 14Proportion of days with oxygen saturation below 93% on room air by Day 14
SecondarySeeking care from healthcare professional for COVID-19 (Clinical outcome #6)Day 0 - Day 14Proportion seeking care from primary care provider/walk-in clinic or study healthcare provider for COVID-19.
SecondaryHospital Admission (Clinical outcome #7)Day 0 to Day 28Duration of hospital admission up to Day 28
SecondaryTime to viral negativity (Virologic/immunological outcome #1)Day 0 to Day 14Time to SARS-CoV-2 RNA negativity.
SecondaryMean log of SARS-CoV-2 RNA (Virologic/immunological outcome #2)Day 3, 5, 7, 10 and 14Difference in mean SARS-CoV-2 RNA in log copies/mL
SecondaryMean log decline in SARS-CoV-2 RNA (Virologic/immunological outcome #3)Day 3, 5, 7, 10 and 14Difference in mean log decline in SARS-CoV-2 RNA.
SecondaryNegative for SARS-CoV-2 RNA (Virologic/immunological outcome #4)Day 3Proportion negative for SARS-CoV-2 RNA.
SecondaryNegative for SARS-CoV-2 RNA (Virologic/immunological outcome #5)Day 7Proportion negative for SARS-CoV-2 RNA.
SecondaryNegative for SARS-CoV-2 RNA (Virologic/immunological outcome #6)Day 14Proportion negative for SARS-CoV-2 RNA.
SecondaryProportion with antibodies (Virologic/immunological outcome #7)Day 0, 7, 14 and 90Proportion with SARS-CoV-2 antibodies in blood.
SecondaryCorrelation with interferon lambda 4 genotype (Virologic/immunological outcome #8)Day 0 to Day 28Correlation of response with interferon lambda 4 (IFNL4) genotype.
SecondaryLaboratory markers (Virologic/immunological outcome #9)Day 0 to Day 7 and Day 7 to Day 14.Change in hemoglobin over time
SecondaryLaboratory markers (Virologic/immunological outcome #10)Day 0 to Day 7 and Day 7 to Day 14.Change in white blood cell count over time

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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