Trial · Interventional
CompletedPhase 4Registry dataEgypt
1 trial · 1 completed
Clinical Characteristics and Treatment of Anosmia and Ageusia Due to SARS-CoV2 Variants
NCT0620854030 Aug 2021 to 30 May 2024
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Active comparator
Patients group (with interventional treatment)
Patients with persistent smell and taste disorders and treated with cerebrolysin
Placebo comparator
Control
Patients with persistent smell and taste disorders but untreated with cerebrolycin (no intervention)
Outcomes the sponsor listed as primary.
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.
The Globas Rating for smell (GRS)
Time frame · after 6, 8, 12, 16, 20 and 24 weeks from baseline
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
The Globas Rating for taste (GRT)
Time frame · after 6, 8, 12, 16, 20 and 24 weeks from baseline
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
Objective re-evaluation
Time frame · After 6, 8, 10, 12, 16, 20 and 24 weeks from baseline
Sniffin' odor, taste and flavor identification tests as described in the previous section.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2023
Hamed et al. 2023Expert review of clinical pharmacologycited by 6
PMID 37950370DOI 10.1080/17512433.2023.2282715PUB-37950370
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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