Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia

NCT04830943 | Completed Phase 3

• 1 other identifier: COVID-NGF/AUH_SAH/2020
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19 Related Anosmia and Aguesia

Keywords

COVID-19; ; anosmia; ; ageusia; ; cerebrolysin

Outcome Measures

Primary Outcomes (2)

• 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.

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

  The subject smell and taste sensations at baseline (presentation)

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

  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.

  at presentation (baseline)

Secondary Outcomes (3)

• The Globas Rating for smell (GRS)

  8 weeks, 12 weeks, 16 weeks, 18 weeks and 24 weeks

• The Globas Rating for taste (GRT)

  8 weeks, 12 weeks, 18 weeks and 24 weeks

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

  at 8, 12, 16, 18 and 24 weeks after intial evaluation at baseline

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Cerebrolysin

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.

Interventions

Cerebrolysin DRUG

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

Also known as: Neurotropic factors

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

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Prior neurologic, medical or psychiatric disease.
• Other known infection at onset
• Nasal congestion
• Nasal polyps
• Surgery or head trauma or radiation for head and neck cancers as may result in injury to the nerves that control smell
• Exposure to toxic chemicals (such as pesticides and solvents)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals, Faculty of Medicine

Asyut, 71516, Egypt

Location

Related Publications (5)

• Chachkhiani D, Soliman MY, Barua D, Isakadze M, Villemarette-Pittman NR, Devier DJ, Lovera JF. Neurological complications in a predominantly African American sample of COVID-19 predict worse outcomes during hospitalization. Clin Neurol Neurosurg. 2020 Oct;197:106173. doi: 10.1016/j.clineuro.2020.106173. Epub 2020 Aug 25.

  PMID: 32877769 BACKGROUND

• Shrestha GS, Khanal S, Sharma S, Nepal G. COVID-19: Current Understanding of Pathophysiology. J Nepal Health Res Counc. 2020 Nov 13;18(3):351-359. doi: 10.33314/jnhrc.v18i3.3028.

  PMID: 33210623 BACKGROUND

• Veinbergs I, Mante M, Mallory M, Masliah E. Neurotrophic effects of Cerebrolysin in animal models of excitotoxicity. J Neural Transm Suppl. 2000;59:273-80. doi: 10.1007/978-3-7091-6781-6_29.

  PMID: 10961439 BACKGROUND

• Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.

  PMID: 32253535 RESULT

• Hamed SA, Ahmed MAA. 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. Expert Rev Clin Pharmacol. 2023 Jul-Dec;16(12):1261-1276. doi: 10.1080/17512433.2023.2282715. Epub 2023 Dec 9.

  PMID: 37950370 DERIVED

MeSH Terms

Conditions

COVID-19; Anosmia; Ageusia

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Taste Disorders

Study Officials

• Sherifa A Hamed, M.D.

  Assiut University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: April 5, 2021
• Study Start: August 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)