Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia
Condition: Covid19 Related Anosmia and Aguesia
MeSH terms: COVID-19; Anosmia
Study type: Interventional
Phase: Phase 3

Summary: 
      The loss of smell and taste is a prominent symptom of COVID-19. Studies found that patterns
      of smell loss due to Covid-19 infection differ from that of other respiratory viruses being
      much more profound in the Covid-19 patents and did not associate with runny, congested, or
      blocked-up nose. The researchers suggest that smell and taste testing can be used for fast
      COVID-19 screening. Studies found that the Covid-19 virus has similarities with severe acute
      respiratory syndrome coronavirus (SARS-CoV), which has been reported to enter the brain, via
      smell receptors in the nose. The sudden onset and relatively fast recovery in some patients
      suggest that COVID-19 anosmia is not caused by damage to the central nervous system but
      rather by the loss of smell information before it gets to the brain (smell receptors). They
      also found that it has different behavior from other respiratory viruses as it causes
      over-reaction of the immune system (or a cytokine storm). Trials to treat post-COVID anosmia
      using local steroid applications, snifﬁng of strong odors or scents or use of different
      vitamins (for several weeks to months) did not provide rapid, satisfactory or even
      significant recovery of olfactory dysfunction. Fortunately, the olfactory neurons can
      regenerate, however, studies reported variable prognoses, some patients recovered within
      weeks which others may have persistent deficits for months or even a year. In this study, the
      researchers hypothesize that cerebrolysin, a drug of neurotrophic and neuroprotective
      properties, can be used to treat patients with persistent post-COVID anosmia or ageusia or
      promote functional recovery of smell and taste deficits.
    

Detailed description: 
      Initial descriptions of the COVID-19 pandemic have focused on its acute severe
      manifestations. After several months, data have emerged about the mild disease and Post-COVID
      syndrome. The diminished senses of smell (or hyposmia/anosmia) and taste (or
      hypogeusia/ageusia) have been commonly reported in the pandemic. Hyposmia/anosmia and
      hypogeusia/ageusia have also been reported with previous coronaviruses. In late March, the
      professional society of Ear, Nose, and Throat (ENT) in the United Kingdom (UK) published an
      advisory on evidence from South Korea, China, and Italy that signiﬁcant number of COVID-19
      positive patients also lost smell and/or taste. Based also on several other reports which
      reported that 66-88% of patients have lost smell and/or taste due to COVID-19 infection, the
      American Academy of Otolaryngology-Head and Neck Surgery and World Health Organization (WHO)
      have added anosmia and ageusia to the list of symptoms of COVID-19. The prognosis of such
      deficits seems variable. Some reported recovery within few weeks; while many reported
      persistence of deficits for several months or even more than a year after the onset of the
      condition. Furthermore, some patients developed respiratory symptoms later after anosmia
      while others remained asymptomatic. The exact mechanisms for these deficits are still under
      research. In animal models, the investigators found that coronaviruses could impair the
      olfactory neuroepithelium through the expression of angiotensin-converting enzyme type 2
      (ACE2) in the sustentacular cells or damage the receptors. Treatment trials of post-COVID
      anosmia included the application of nasal corticosteroids, regular snifﬁng of different odors
      and strong scents, and treatment with antioxidants and vitamins or interventions as olfactory
      training. However, none was therapeutically effective. Previous preclinical and clinical
      studies have shown that treatment with neurotrophic polypeptides can promote neurological
      recovery for many neurodegenerative and acquired nervous system diseases due to different
      causes. As the olfactory neurons are capable of regeneration, the researchers propose that
      treating patients with prolonged post-COVID anosmia or ageusia using cerebrolysin, a drug of
      neurotrophic and neuroprotective properties may promote recovery of olfactory and gustatory
      dysfunctions. Cerebrolysin is a mixture of peptides purified from brains, including (and not
      limited to) brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic
      factor (GDNF), nerve growth factor (NGF), and ciliary neurotrophic factor (CNTF).
    

Intervention name(s): Cerebrolysin
Intervention type(s): Drug
Intervention description(s): Cerebrolysin will be prescribed in a dose of 5 ml ampoule once daily through intramuscular injection (1ml contains 215.2 mg cerebrolysin) for five times per week, for a total of 40 treatments (for 8 weeks), after which the cycle was individually repeated according to the response of the patient to therapy for a maximum of 24 weeks
Other intervention name(s): Neurotropic factors
Intervention MeSH terms: Cerebrolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; ; anosmia; ; ageusia; ; cerebrolysin