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Trial · NCT04007562

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimaryCreatine kinase dosage in plasma36 months
PrimaryInflammatory cytokines in plasma36 monthsQuantitative flow cytometry based mutliplex assays (flow cytometry-based systems (BD™ Cytometric Bead Array)).
PrimaryQuantification of mitochondrial DNA in plasma36 monthsQuantitative PCR to detect mitochondrial DNA, 12s gene.
SecondaryOccurrence of intercurrent event36 monthsClinical examination.
SecondaryOccurrence of rash36 monthsClinical examination.
SecondaryGowers sign appearance36 monthsClinical examination.
SecondaryOccurrence of shortness of breath36 monthsClinical examination.
SecondaryOccurrence of muscular fatigability36 monthsClinical examination.
SecondaryTreatment compliance36 monthsPatient interrogation.
SecondaryOccurrence of adverse effect36 monthsPatient interrogation.
SecondaryDosing of Hydroxychloroquine Sulfate in plasma36 monthsCompliance.
SecondaryOccurence of retinopathy.36 monthsFundus eye and electroretinogram.
SecondaryQuotation of the different muscles36 monthsMuscle testing by a physiotherapist.
Secondary6-min walking test36 months
SecondaryTest of the number of steps during a 3-min walk36 months
SecondaryAssessment of pain: VAS36 monthsVisual analogue scale (VAS) : scale from 1 to 10; compare from one examination to another for a patient (which is his own control).
SecondaryQuality-of-life assessment: Pediatric Quality of Life InventoryTM (PedsQL) questionnaire36 months
Pediatric Quality of Life InventoryTM (PedsQL) questionnaire adapted to age: child questionnaire and parent questionnaire. Questionnaire of 23 questions scored on 5 points, from 0 (never) to 4 (almost always). The scores are linearly transformed on a scale between 0 and 100, added together and divided by the number of items completed; high scores are associated with a better quality of life related to health.
SecondaryEchocardiography36 monthsMeasurement of the wall of the ventricles, ejection fraction.
SecondaryAbsence of cardiac arrhythmia36 monthsElectrocardiography

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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