Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia

Status

Completed

Phase

Phase 3

Enrollment

250 participants (actual)

Sponsor

Assiut University · Other

Design

Randomized · Open label (no masking)

Countries

1 country

Egypt

Start

1 Aug 2020

Primary completion

30 Sept 2021

Completion

30 Oct 2022

First posted

5 Apr 2021

Last update posted

3 Jan 2023

Conditions

Covid19 Related Anosmia and Aguesia

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.

• Experimental

  Olfactory and gustatory disorders after covid 19 infection (n = 150)

  Cerebrolysin Dose:5 ml ampoule (1ml contains 215.2 mg cerebrolysin) once daily through intramuscular injection five times per week, for a total of 40 treatments (for at least 8 weeks after presentation), after which the cycle was repeated again according to the each patient response to therapy for a maximum of 24 weeks.

• No intervention

  control group (n = 100)

  no drug intervention, just olfactory training using at least 4 strong odors to smell twice daily for at least 15 minutes (every time), for at least 8 weeks after presentation.

1. The smell and taste questionnaire component of the National Health and Nutrition Examination Survey (NHNES). And the modified Arabic translated and validated sniffin' sticks odor identification test was used for objective olfactory evaluations.

   Time frame · The subject smell and taste sensations at baseline (presentation)

   Registry description

   The NHNES questions have been selected to characterize the variation, timing and associated-symptoms of both olfactory and gustatory systems.

2. objective testings: sniffen's odor, taste and flavor identification testing

   Time frame · at presentation (baseline)

   Registry description

   For quantitative assessment of smell, we used 16 odors familiar to Egyptians For quantitative assessment of taste loss, we used sugar (sweet), salt (salty), lemon (sour), old rumi cheese chips (umami) and coffee (bitter), the five basic tastants. For quantitative assessment of flavor, we used 16 recipes familiar for Egyptians.