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Trial · NCT04668209

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryIncidence of Treatment Emergent Adverse Events [Safety and Tolerability]Through Day 60
Adverse Events experienced by the patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
SecondaryTo Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.Through Day 28
Number of days from randomization to discharge, or to alleviation of cough (defined as mild or absent in a patient reported scale of 0=absent, 1=mild, 2=moderate, and 3=severe). Improvement must be sustained for at least 48 hours.
SecondaryTo Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.Through hospital discharge, an average of 28 days
Number of days from randomization to normalization of fever (defined as \<36.6°C from axillary site, or \< 37.2°C from oral site or \< 37.8°C from rectal or tympanic site), normalization of respiratory rate (\< 24 bpm while breathing room air), resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for at least 48 hours.
SecondaryTo Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.Through Day 28
Number of days from randomization to the first day on which the subject satisfies one of the following three categories from the ordinal NIAID 8- point Clinical Progression Outcomes scale collected daily from randomization through Day 28: Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.
SecondaryTo Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.Assessed on Day 14 and Day 28Difference in percentage of subjects with clinical recovery compared at Day 14 and Day 28.
SecondaryTo Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.Through Day 28
Percentage of Participants at Each Clinical Status at Day 14 and Day 28 assessed by using the ordinal NIAID 8- point Clinical Progression Outcomes scale (Scale ranges from 1 (Death) to 8 (Not hospitalized, no limitations on activities)
SecondaryTo Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.Assessed at Day 1, Day 8, Day 14 and Day 28Difference in proportions of patients with conversion of positive RT-PCR to negative RT-PCR as assessed at Day 1, Day 8, Day 14 and Day 28.
SecondaryTo Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.Through Day 14Changes in chest imaging from Screening to Day 5 or 14
SecondaryNumber of Days HospitalizedThrough Day 28Days of hospitalization from randomization through Day 28
SecondaryTo Evaluate Changes in IL-6 LevelAssessed on Days 1, 4, 8, 11, and 14IL-6 level
SecondaryTo Evaluate Changes in CRPAssessed on Days 1, 4, 8, 11, and 14CRP level
SecondaryTo Evaluate Changes in LDHAssessed on Days 1, 4, 8, 11, and 14LDH level
SecondaryTo Evaluate Changes in CPKAssessed on Days 1, 4, 8, 11, and 14CPK level
SecondaryTo Evaluate Changes in FerritinAssessed on Days 1, 4, 8, 11, and 14Ferritin level
SecondaryTo Evaluate Changes in D-dimerAssessed on Days 1, 4, 8, 11, and 14D-dimer level
SecondaryNumber of Days of Supplemental Oxygen UseThrough Day 28Days of supplemental oxygen (if applicable) from randomization through day 28
SecondaryAll-cause Mortality StatusThrough Day 60The number of deaths occurred in each treatment group from randomization through Day 60
SecondaryNumber of Days of On-invasive Ventilation/High Flow OxygenThrough Day 28Days of non-invasive ventilation/high flow oxygen (if applicable) from randomization through day 28
SecondaryNumber of Days of Invasive Mechanical Ventilation/ECMOThrough Day 28Days of invasive mechanical ventilation/ECMO (if applicable) from randomization through Day 28.
SecondaryNumber of Patients Returned to Room AirThrough Day 28Number of patients returned to room air after randomization through Day 14 or Day 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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