Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia

What Was Tested

In this phase 3 trial, researchers set out to test Cerebrolysin.

The loss of smell and taste is a prominent symptom of COVID-19.

It had two arms (groups): Olfactory and gustatory disorders after covid 19 infection (n = 150) (experimental) and control group (n = 100) (no intervention).

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.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

250 actual participants took part.

It was open to people of any sex aged from 20 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A random sample of at least 250 adults with sudden hyposmia/anosmia and/or hypoageusia/ageusia during COVID-19 pandemics and experienced persistent olfactory and/or gustatory manifestations after recovery from other acute viral manifestations. Compliance for drug intervention (group 1) or olfactory training (group 2) for at least 8 weeks.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: prior neurologic, medical or psychiatric disease; other known infection at onset; nasal congestion.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Cerebrolysin and who got the comparison, which limits bias.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

Being open-label, the Cerebrolysin study did not mask who received what.

It started in 2020-08-01 with completion listed for 2021-09-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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)). objective testings: sniffen's odor, taste and flavor identification testing (time frame: at presentation (baseline)).

It also tracked 3 secondary outcomes, for example The Globas Rating for smell (GRS), The Globas Rating for taste (GRT) and objective testings: sniffen's odor, taste and flavor identification testing.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cerebrolysin in 250 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, all human trials.