Post-covid-19 Persistent Smell and Taste DisordersPhase 4NCT06208540
Clinical Characteristics and Treatment of Anosmia and Ageusia Due to SARS-CoV2 Variants
A Phase 4 study testing Cerebrolysin and olfactory and gustatory trainings in people with Post-covid-19 Persistent Smell and Taste Disorders, run by Sherifa Ahmed Hamed at 2 sites in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Post-covid-19 Persistent Smell and Taste Disorders
- What is being tested?
- Cerebrolysin and olfactory and gustatory trainings
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Aug 2021to 30 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to 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.
Who cannot join
- Prior neurological, medical or psychiatric disease which are known as a cause of progressive olfactory or gustatory dysfunction
- 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) Cocaine or other drug abuse
- Lack of compliance to drug treatment or olfactory and gustatory trainings for at least 8 weeks.
- Lack of cooperation to complete the objective testings.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut University Hospitals, Faculty of Medicine, Hospital of Neurology, Neurosurgery and Psychiatry, Assiut University Hospital, Assiut, Egypt
Asyut, 71516
Assiut University, Faculty of Medicine, Hospital of Neurology, Psychiatry and Neurosurgery
Asyut, 71516
About this study
Official title: Persistent Olfactory and Gustatory Dysfunctions Due to Different SARS-CoV-2 Variants: Clinical Characteristics and Treatment
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. Studies from different parts of the world have demonstrated significant variations in the clinical manifestations of viral infection in relation to different SARS-CoV-2 variants. They also indicated that the current high levels of population immunity, due to prior infection and/or vaccination, have been associated with a vastly decreased overall risk of severe disease. Anosmia (with or without ageusia) was identified as a hallmark of COVID-19 early in the pandemic (ancestral Wuhan strain, alpha and delta variants), with a prevalence of ~60%. Prolonged olfactory disorders, lasting ≥6 months to years, has been reported in ~35-40% of infected individuals. However, studies reported that olfactory and gustatory disorders were less frequent with Omicron variants compared to pre-omicron variants. It has been indicated that SARS-CoV-2 can cause destruction, disorganization and molecular changes in the nasal olfactory neuroepithelium resulting in loss and distortion of the sense of smell. There are several trials to treat these persistent disorders but none has shown significant positive results except ours (Hamed et al., Expert Review of Clinical Pharmacology 2023;16(12):1261-1276 DOI: 10.1080/17512433.2023.2282715). Hamed et al. reported that cerebrolycin, a commercially available multimodal neurotropic factor, has the ability to cure at least 60% (100% complete and persistent recovery) of post-covid-19 persistent olfactory and gustatory dysfunctions. This drug is available in the market of at least 75 countries since 1996 and easily dispensed from local pharmacies after doctors prescriptions. It is used for treatment of many disorders of the central and peripheral nervous systems. This could be due to its ability to promote neurogenesis and remodeling of olfactory and gustatory neurons.
Read the detailed description
The diminished senses of smell (or hyposmia/anosmia) and taste (or hypogeusia/ageusia) have been commonly reported after infection by ancestral Wuhan, alpha and delta strains of the SARS-CoV-2 virus in ≥ 60% of patients. Persisted dysfunctions (deficits and distortions), lasting for months to years, were also reported in ~40%.
The SARS-CoV-2 pandemic has different waves of infection because of the dynamic viral mutations. The first wave (ancestral Wuhan strain) has been defined as the period from approximately the last week of February 2020 to the first Week of February 2021; the second wave (Alpha variant) started from approximately week 7 of February 2021 to July 2021; the third wave (Delta variant) was the period from approximately August 2021 to December 2021; and the fourth wave (Omicron and its subvariants) was the period from approximately January 2022 to December 2023 and after. 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).
Experimental studies strongly indicated that post-covid olfactory and gustatory disorders are due to peripheral damage of the sensory neuroepithelia (olfactory and gustatory) and their disorganization by severe viral infection and its immune mediated pathology.
In general, the characterization of the prevalence and clinical manifestations and risk variables of olfactory and gustatory complications of different SARS-CoV-2 variants is unclear. furthermore, the treatment of these prolonged complications is still aworldwide challenge. Detailed search in clinical trials' websites, for example: WHO International Clinical Trials Registry Platform (ICTRP Search Portal-WHO; https://trialsearch.who.int/), Cochrane ENT Trials Register (https://ent.cochrane.org), Ovid Embase (https://tools.ovid.com), ClinicalTrials.gov, Medfind (https:// medfind.in), Web of Science, PubMed and Scopus, demonstrated that there is only a completed and published trial which showed promising positive and maintained results (Hamed et al., 2023). In this trial, the authors concluded that cerebrolysin, a commercially available multimodal neurotropic factor, had fast, promising, and constant effect, with cure rate of >/+ 60%. This could be due to its ability to initiate and enhance neuronal regeneration, reorganization and remodeling of sensory neuroepithelia.
- Being tested
- Cerebrolysin, olfactory and gustatory trainings
- Keywords
- COVID-19, SARS-CoV-2, variants of concern, variants of interest, Alpha strain, Delta strain, Omicron strain, Predelta period, Delta period, Omicron and its variants period
- Medical subject headings
- Taste Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Also called Active arm
Cerebrolysin Dose:5 ml ampoule (1ml contains 215.2 mg cerebrolysin) once daily through intramuscular injection five times per week, for a total of 20 treatments (for 4 weeks), after which the cycle was repeated again for at least 6 weeks till a maximum of 24 weeks.
olfactory and gustatory trainingsOther
Also called controls
olfactory and gustatory trainings using oils of strong odors for the same time frame as for the drug intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients group (with interventional treatment) | Active comparator | Patients with persistent smell and taste disorders and treated with cerebrolysin Receives: Drug: Cerebrolysin; Other: olfactory and gustatory trainings |
| Control | Placebo comparator | Patients with persistent smell and taste disorders but untreated with cerebrolycin (no intervention) Receives: Other: olfactory and gustatory trainings |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective evaluation
It included data collection of demographic, general and systemic clinical and treatment characteristics of patients infected by different SARS-CoV-2 variants. it also included the smell and taste questionnaire component of the National Health and Nutrition Examination Survey (NHNES).The dominant viral variant was defined according to the period of the development of viral manifestations including olfactory and gustatory disorders. We defined pre-delta period as February 2020 to end of May 2021; delta period as first of June 2021 till the end of December 2021; Omicron variant and its subvariants period as early in January 2022 till the end of the recruitment period.
Measured: Baseline
Objective evaluation
It included application of modified Arabic translated and validated sniffin' odor, taste and flavor identification tests were used for objective evaluations. We used 16 different odorants which are well-known for our population. According to the results, patients were classified as normosmic (score: 12-16), hyposmic (score: 9-11) or anosmic (score: equal or less than 8). Flavor identification test was done using the same recipes as in olfactory identification test. Taste identification test was done using a five known tastants which represented the five base taste sensations (salty, sweet, bitter, sour and Umami". Answers used for the result of this test was either correct or incorrect.
Measured: Baseline
Secondary outcomes (3)
The Globas Rating for smell (GRS)
It is a single-item, global rating that asks the patient to rate his current sense of smell as follow: excellent, very good, good, fair, poor or absent
Measured: after 6, 8, 12, 16, 20 and 24 weeks from baseline
The Globas Rating for taste (GRT)
it is a single-item, global rating that asks the patient to rate his current sense of taste as follow: excellent, very good, good, fair, poor or absent
Measured: after 6, 8, 12, 16, 20 and 24 weeks from baseline
Objective re-evaluation
Sniffin' odor, taste and flavor identification tests as described in the previous section.
Measured: After 6, 8, 10, 12, 16, 20 and 24 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start30 Aug 2021
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-covid-19 Persistent Smell and Taste DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherifa Ahmed Hamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherifa Ahmed Hamed, Assiut University
- Investigators
- Sherifa A Hamed, Principal investigator, Assiut University, Faculty of Medicine, Hospital of Neurology, Neurosurgery and Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208540
- Sponsor's protocol ID
- AU-FM-covid-00325_2021
- Status last verified
- Aug 2024
- First submitted
- 11 Jan 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://orcid.org/0000-0002-1441-3530
Publications
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.
PubMed 37950370Hamed SA. Post-COVID-19 persistent olfactory, gustatory, and trigeminal chemosensory disorders: definitions, mechanisms, and potential treatments. World J Otorhinolaryngol. 2023;10(2):4-22. doi: 10.5319/wjo.v10.i2.448
Taquet M, Sillett R, Zhu L, Mendel J, Camplisson I, Dercon Q, Harrison PJ. Neurological and psychiatric risk trajectories after SARS-CoV-2 infection: an analysis of 2-year retrospective cohort studies including 1 284 437 patients. Lancet Psychiatry. 2022 Oct;9(10):815-827. doi: 10.1016/S2215-0366(22)00260-7. Epub 2022 Aug 17.
PubMed 35987197Yau JWK, Lee MYK, Lim EQY, Tan JYJ, Tan KBJC, Chua RSB. Genesis, evolution and effectiveness of Singapore's national sorting logic and home recovery policies in handling the COVID-19 Delta and Omicron waves. Lancet Reg Health West Pac. 2023 Jun;35:100719. doi: 10.1016/j.lanwpc.2023.100719. Epub 2023 Mar 2.
PubMed 37360873Micheletti C, Medori MC, Dhuli K, Maltese PE, Cecchin S, Bonetti G, Fioretti F, Assoni L, Calzoni A, Praderio A, De Angelis MG, Donato K, Arabia G, Lorusso L, Manganotti P, Capelli E, Marceddu G, Bertelli M, Nodari S. Linking pathogenic and likely pathogenic gene variants to long-COVID symptoms. Eur Rev Med Pharmacol Sci. 2023 Dec;27(6 Suppl):20-32. doi: 10.26355/eurrev_202312_34686.
PubMed 38112945Velavan TP, Ntoumi F, Kremsner PG, Lee SS, Meyer CG. Emergence and geographic dominance of Omicron subvariants XBB/XBB.1.5 and BF.7 - the public health challenges. Int J Infect Dis. 2023 Mar;128:307-309. doi: 10.1016/j.ijid.2023.01.024. Epub 2023 Jan 19. No abstract available.
PubMed 36681145Hamed SA, Kamal-Eldeen EB, Ahmed MAA. Evaluation of children and adults with post-COVID-19 persistent smell, taste and trigeminal chemosensory disorders: A hospital based study. World J Clin Pediatr. 2023 Jun 9;12(3):133-150. doi: 10.5409/wjcp.v12.i3.133. eCollection 2023 Jun 9.
PubMed 37342446
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Olfactory and Gustatory Dysfunctions Due to Different SARS-CoV-2 Variants: Clinical Characteristics and Treatment
- ClinicalTrials.gov ID
- NCT06208540
- Acronym / sponsor ID
- AU-FM-covid-00325_2021
- Keywords
- COVID-19, SARS-CoV-2, variants of concern, variants of interest, Alpha strain, Delta strain, Omicron strain, Predelta period
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Sherifa Ahmed HamedUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Studies from different parts of the world have demonstrated significant variations in the clinical manifestations of viral infection in relation to different SARS-CoV-2 variants. They also indicated that the current high levels of population immunity, due to prior infection and/or vaccination, have been associated with a vastly decreased overall risk of severe disease. Anosmia (with or without ageusia) was identified as a hallmark of COVID-19 early in the pandemic (ancestral Wuhan strain, alpha and delta variants), with a prevalence of ~60%. Prolonged olfactory disorders, lasting ≥6 months to years, has been reported in ~35-40% of infected individuals. However, studies reported that olfactory and gustatory disorders were less frequent with Omicron variants compared to pre-omicron variants. It has been indicated that SARS-CoV-2 can cause destruction, disorganization and molecular changes in the nasal olfactory neuroepithelium resulting in loss and distortion of the sense of smell. There are several trials to treat these persistent disorders but none has shown significant positive results except ours (Hamed et al., Expert Review of Clinical Pharmacology 2023;16(12):1261-1276 DOI: 10.1080/17512433.2023.2282715). Hamed et al. reported that cerebrolycin, a commercially available multimodal neurotropic factor, has the ability to cure at least 60% (100% complete and persistent recovery) of post-covid-19 persistent olfactory and gustatory dysfunctions. This drug is available in the market of at least 75 countries since 1996 and easily dispensed from local pharmacies after doctors prescriptions. It is used for treatment of many disorders of the central and peripheral nervous systems. This could be due to its ability to promote neurogenesis and remodeling of olfactory and gustatory neurons.
Detailed description
The diminished senses of smell (or hyposmia/anosmia) and taste (or hypogeusia/ageusia) have been commonly reported after infection by ancestral Wuhan, alpha and delta strains of the SARS-CoV-2 virus in ≥ 60% of patients. Persisted dysfunctions (deficits and distortions), lasting for months to years, were also reported in ~40%.
The SARS-CoV-2 pandemic has different waves of infection because of the dynamic viral mutations. The first wave (ancestral Wuhan strain) has been defined as the period from approximately the last week of February 2020 to the first Week of February 2021; the second wave (Alpha variant) started from approximately week 7 of February 2021 to July 2021; the third wave (Delta variant) was the period from approximately August 2021 to December 2021; and the fourth wave (Omicron and its subvariants) was the period from approximately January 2022 to December 2023 and after. 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).
Experimental studies strongly indicated that post-covid olfactory and gustatory disorders are due to peripheral damage of the sensory neuroepithelia (olfactory and gustatory) and their disorganization by severe viral infection and its immune mediated pathology.
In general, the characterization of the prevalence and clinical manifestations and risk variables of olfactory and gustatory complications of different SARS-CoV-2 variants is unclear. furthermore, the treatment of these prolonged complications is still aworldwide challenge. Detailed search in clinical trials' websites, for example: WHO International Clinical Trials Registry Platform (ICTRP Search Portal-WHO; https://trialsearch.who.int/), Cochrane ENT Trials Register (https://ent.cochrane.org), Ovid Embase (https://tools.ovid.com), ClinicalTrials.gov, Medfind (https:// medfind.in), Web of Science, PubMed and Scopus, demonstrated that there is only a completed and published trial which showed promising positive and maintained results (Hamed et al., 2023). In this trial, the authors concluded that cerebrolysin, a commercially available multimodal neurotropic factor, had fast, promising, and constant effect, with cure rate of >/+ 60%. This could be due to its ability to initiate and enhance neuronal regeneration, reorganization and remodeling of sensory neuroepithelia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients group (with interventional treatment) | Active comparator | Drug: Cerebrolysin, Other: olfactory and gustatory trainingsPatients with persistent smell and taste disorders and treated with cerebrolysin |
| Control | Placebo comparator | Other: olfactory and gustatory trainingsPatients with persistent smell and taste disorders but untreated with cerebrolycin (no intervention) |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Prior neurological, medical or psychiatric disease which are known as a cause of progressive olfactory or gustatory dysfunction
- 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) Cocaine or other drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerebrolysinAlso: Active armCerebrolysin Dose:5 ml ampoule (1ml contains 215.2 mg cerebrolysin) once daily through intramuscular injection five times per week, for a total of 20 treatments (for 4 weeks), after which the cycle was repeated again for at least 6 weeks till a maximum of 24 weeks. | Drug | Patients group (with interventional treatment) |
| olfactory and gustatory trainingsAlso: controlsolfactory and gustatory trainings using oils of strong odors for the same time frame as for the drug intervention | Other | Control, Patients group (with interventional treatment) |
Primary outcome
subjective evaluation
Time frame: Baseline
It included data collection of demographic, general and systemic clinical and treatment characteristics of patients infected by different SARS-CoV-2 variants. it also included the smell and taste questionnaire component of the National Health and Nutrition Examination Survey (NHNES).The dominant viral variant was defined according to the period of the development of viral manifestations including olfactory and gustatory disorders. We defined pre-delta period as February 2020 to end of May 2021; delta period as first of June 2021 till the end of December 2021; Omicron variant and its subvariants period as early in January 2022 till the end of the recruitment period.
Objective evaluation
Time frame: Baseline
It included application of modified Arabic translated and validated sniffin' odor, taste and flavor identification tests were used for objective evaluations. We used 16 different odorants which are well-known for our population. According to the results, patients were classified as normosmic (score: 12-16), hyposmic (score: 9-11) or anosmic (score: equal or less than 8). Flavor identification test was done using the same recipes as in olfactory identification test. Taste identification test was done using a five known tastants which represented the five base taste sensations (salty, sweet, bitter, sour and Umami". Answers used for the result of this test was either correct or incorrect.
3 secondary outcomes
The Globas Rating for smell (GRS)
Time frame: after 6, 8, 12, 16, 20 and 24 weeks from baseline
The Globas Rating for taste (GRT)
Time frame: after 6, 8, 12, 16, 20 and 24 weeks from baseline
Objective re-evaluation
Time frame: After 6, 8, 10, 12, 16, 20 and 24 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Results publication: PubMed 37950370Hamed 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.
- Results publicationHamed SA. Post-COVID-19 persistent olfactory, gustatory, and trigeminal chemosensory disorders: definitions, mechanisms, and potential treatments. World J Otorhinolaryngol. 2023;10(2):4-22. doi: 10.5319/wjo.v10.i2.448
- Results publication: PubMed 35987197Taquet M, Sillett R, Zhu L, Mendel J, Camplisson I, Dercon Q, Harrison PJ. Neurological and psychiatric risk trajectories after SARS-CoV-2 infection: an analysis of 2-year retrospective cohort studies including 1 284 437 patients. Lancet Psychiatry. 2022 Oct;9(10):815-827. doi: 10.1016/S2215-0366(22)00260-7. Epub 2022 Aug 17.
- Results publication: PubMed 37360873Yau JWK, Lee MYK, Lim EQY, Tan JYJ, Tan KBJC, Chua RSB. Genesis, evolution and effectiveness of Singapore's national sorting logic and home recovery policies in handling the COVID-19 Delta and Omicron waves. Lancet Reg Health West Pac. 2023 Jun;35:100719. doi: 10.1016/j.lanwpc.2023.100719. Epub 2023 Mar 2.
- Results publication: PubMed 38112945Micheletti C, Medori MC, Dhuli K, Maltese PE, Cecchin S, Bonetti G, Fioretti F, Assoni L, Calzoni A, Praderio A, De Angelis MG, Donato K, Arabia G, Lorusso L, Manganotti P, Capelli E, Marceddu G, Bertelli M, Nodari S. Linking pathogenic and likely pathogenic gene variants to long-COVID symptoms. Eur Rev Med Pharmacol Sci. 2023 Dec;27(6 Suppl):20-32. doi: 10.26355/eurrev_202312_34686.
- Results publication: PubMed 36681145Velavan TP, Ntoumi F, Kremsner PG, Lee SS, Meyer CG. Emergence and geographic dominance of Omicron subvariants XBB/XBB.1.5 and BF.7 - the public health challenges. Int J Infect Dis. 2023 Mar;128:307-309. doi: 10.1016/j.ijid.2023.01.024. Epub 2023 Jan 19. No abstract available.
- Results publication: PubMed 37342446Hamed SA, Kamal-Eldeen EB, Ahmed MAA. Evaluation of children and adults with post-COVID-19 persistent smell, taste and trigeminal chemosensory disorders: A hospital based study. World J Clin Pediatr. 2023 Jun 9;12(3):133-150. doi: 10.5409/wjcp.v12.i3.133. eCollection 2023 Jun 9.
- Individual participant dataSharing planned: Yes. http://orcid.org/0000-0002-1441-3530
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherifa A Hamed principal investigator
Assiut University, Faculty of Medicine, Hospital of Neurology, Neurosurgery and Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerebrolysin and olfactory and gustatory trainings in people with Post-covid-19 Persistent Smell and Taste Disorders, run by Sherifa Ahmed Hamed at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective evaluation (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06208540, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.