NCT04830943

Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia

Completed Phase 3 Last updated 3 January 2023

What this trial tests

Phase 3 trial testing Cerebrolysin in Covid19 Related Anosmia and Aguesia in 250 participants. Completed in 30 October 2022.

Timeline

1 August 2020

Primary endpoint
30 September 2021

30 October 2022

Quick facts

Lead sponsor	Assiut University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	250
Start date	1 August 2020
Primary completion	30 September 2021
Estimated completion	30 October 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Cerebrolysin — full drug profile →

Conditions studied

• Covid19 Related Anosmia and Aguesia — all drugs for Covid19 Related Anosmia and Aguesia →

Sponsor

Assiut University

Who can join

Adults 20 to 50, any sex, with Covid19 Related Anosmia and Aguesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction.
   O'Byrne L, Webster KE, MacKeith S, Philpott C, et al · · 2022 · cited 21× · PMID 36062970 · DOI 10.1002/14651858.cd013876.pub3
2. Review of COVID-19 Therapeutics by Mechanism: From Discovery to Approval.
   Choi HS, Choi AY, Kopp JB, Winkler CA, et al · · 2024 · cited 13× · PMID 38622939 · DOI 10.3346/jkms.2024.39.e134
3. Post-COVID-19 Anosmia and Therapies: Stay Tuned for New Drugs to Sniff Out.
   Riccardi G, Niccolini GF, Bellizzi MG, Fiore M, et al · · 2023 · cited 11× · PMID 37366867 · DOI 10.3390/diseases11020079
4. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction.
   Webster KE, O'Byrne L, MacKeith S, Philpott C, et al · · 2022 · cited 11× · PMID 36063364 · DOI 10.1002/14651858.cd013877.pub3
5. The effectiveness of cerebrolysin, a multi-modal neurotrophic factor, for treatment of post-covid-19 persistent olfactory, gustatory and trigeminal chemosensory dysfunctions: a randomized clinical trial.
   Hamed SA, Ahmed MAA. · · 2023 · cited 6× · PMID 37950370 · DOI 10.1080/17512433.2023.2282715
6. SARS-Cov-2 Damage on the Nervous System and Mental Health.
   Boulkrane MS, Ilina V, Melchakov R, Arisov M, et al · · 2022 · cited 4× · PMID 34191699 · DOI 10.2174/1570159x19666210629151303