Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830943
Status:
COMPLETED
Last Update Posted:
2023-01-03
First Post:
2020-12-24
Brief Title:
Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
The Effectiveness of Cerebrolycin a Multi-modal Neurotrophic Factor for Treatment of Post-covid-19 Persistent Olfactory Gustatory and Trigeminal Chemosensory Dysfunctions A Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 hyposmiaanosmia and taste or hypogeusiaageusia have been commonly reported in the pandemic Hyposmiaanosmia and hypogeusiaageusia have also been reported with previous coronaviruses In late March the professional society of Ear Nose and Throat ENT in the United Kingdom UK published an advisory on evidence from South Korea China and Italy that significant number of COVID-19 positive patients also lost smell andor taste Based also on several other reports which reported that 66-88 of patients have lost smell andor taste due to COVID-19 infection the American Academy of Otolaryngology-Head and Neck Surgery and World Health Organization WHO have added anosmia and ageusia to the list of symptoms of COVID-19 The prognosis of such deficits seems variable Some reported recovery within few weeks while many reported persistence of deficits for several months or even more than a year after the onset of the condition Furthermore some patients developed respiratory symptoms later after anosmia while others remained asymptomatic The exact mechanisms for these deficits are still under research In animal models the investigators found that coronaviruses could impair the olfactory neuroepithelium through the expression of angiotensin-converting enzyme type 2 ACE2 in the sustentacular cells or damage the receptors Treatment trials of post-COVID anosmia included the application of nasal corticosteroids regular sniffing of different odors and strong scents and treatment with antioxidants and vitamins or interventions as olfactory training However none was therapeutically effective Previous preclinical and clinical studies have shown that treatment with neurotrophic polypeptides can promote neurological recovery for many neurodegenerative and acquired nervous system diseases due to different causes As the olfactory neurons are capable of regeneration the researchers propose that treating patients with prolonged post-COVID anosmia or ageusia using cerebrolysin a drug of neurotrophic and neuroprotective properties may promote recovery of olfactory and gustatory dysfunctions Cerebrolysin is a mixture of peptides purified from brains including and not limited to brain-derived neurotrophic factor BDNF glial cell line-derived neurotrophic factor GDNF nerve growth factor NGF and ciliary neurotrophic factor CNTF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None