Clinical Characteristics and Treatment of Anosmia and Ageusia Due to SARS-CoV2 Variants

What Was Tested

In this phase 4 trial, researchers set out to test Cerebrolysin.

The SARS-CoV-2 pandemic has consisted of multiple surges of infection because of continuous viral mutations.

The WHO and CDC have defined the main SARS-CoV-2 variants based on international and national data for the circulation of SARS-CoV-2 into at least 4 waves.

It had two arms (groups): Patients group (with interventional treatment) (active comparator) and Control (placebo comparator).

Patients with persistent smell and taste disorders and treated with cerebrolysin.

Patients with persistent smell and taste disorders but untreated with cerebrolycin (no intervention).

The registry classes the interventions as drug and other.

More on the Plan

The SARS-CoV-2 pandemic has different waves of infection because of the dynamic viral mutations.

These Viral strains were also categorized according to the main variants and their subvariants based on the viral pathogenicity and transmissibility, the clinical manifestations, immunity and response to vaccination.

Studies from different parts of the world reported less severe viral manifestations in the periods of omicron strain and its subvariants compared to the pre-omicron years of the pandemic.

They also reported less frequent involvement of olfactory and gustatory systems with omicron and its subvariants compared to previous viral variants (alpha and delta).

Who Took Part

Enrollment: 160 actual participants took part.

It was open to people of any sex aged from 10 years up to 70 years.

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

Examples of who could join: Children and adults with sudden hyposmia/anosmia and/or hypoageusia/ageusia during COVID-19 pandemics (2020-2024). Persisting symptoms were defined as disorders lasting ≥6 months. Cooperation during objective evaluation. Compliance to drug treatment or olfactory and gustatory trainings for at least 8 weeks.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: prior neurological, medical or psychiatric disease which are known as a cause of progressive olfactory or gustatory dysfunction; nasal congestion; nasal polyps.

How the Study Was Run

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

Because people in this Cerebrolysin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Cerebrolysin study: the participants and staff both knew the treatment.

It started in 2021-08-30 with completion listed for 2024-04-30.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: subjective evaluation (time frame: Baseline). Objective evaluation (time frame: Baseline).

It also tracked 3 secondary outcomes, for example The Globas Rating for smell (GRS), The Globas Rating for taste (GRT) and Objective re-evaluation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 160 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.