Hidroxicloroquine and cloroquine safety profile in patients with SARS-COV-2 infection (COVID-19) (SEHISACoV-2)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Observational safety study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  COVID-19 treatment

  SARS-CoV-2 test positive

  Viral infection

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  158

Study design details

• Main study objective:
  To determine the frequency of heart alterations in patients with risk factors and who receive hydroxychloroquine or chloroquine.
• Outcomes:
  QT segment length (difference before-after treatment), other ECG alterations, serious adverse events as defined by ICH and grade 3/4 adverse events as classified by CTCAE v.5.
• Data analysis plan:
  The different types of adverse events related to the study medication will be described in terms of frequency table. For the nomenclature of the adverse events, the Dictionary of adverse events’ terminology MEdRA will be used and the classification by grades will follow the criteria of Common Terminology Criteria for Adverse Events (CTCAE) v5.0, published in November 2017. The relative risk will be calculated for cardiac disorders and for the rest of adverse events. The latency period and period from the start of the medication until the appearance of the first symptoms or signs of the adverse reaction will be analyzed. Each event will be expressed as median days and interquartile range. The rest of the qualitative variables will be analyzed by contingency tables and tests of Pearson's chi square test or Fisher's exact test. An intermediate analysis will be performed upon reaching 50% of the recruited sample

Documents

Study publications

Chatre, C., Roubille, F., Vernhet, H. et al. Cardiac Complications Attributed t…

Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic revie…

White NJ. Cardiotoxicity of antimalarial drugs. The Lancet infectious diseases…

Haeusler, I.L., Chan, X.H.S., Guérin, P.J. et al. The arrhythmogenic cardiotoxi…

Tönnesmann E, Kandolf R, Lewalter T. Chloroquine cardiomyopathy–a review of the…