Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia
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|ClinicalTrials.gov Identifier: NCT04830943|
Recruitment Status : Completed
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Related Anosmia and Aguesia||Drug: Cerebrolysin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of Cerebrolycin for Treatment of Post-covid Olfactory and Gustatory Dysfunctions: A Pilot Study|
|Actual Study Start Date :||August 1, 2020|
|Actual Primary Completion Date :||February 28, 2021|
|Actual Study Completion Date :||March 30, 2021|
Olfactory and gustatory disorders after covid 19 infection
Cerebrolysin Dose:10 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 8 more weeks.
Cerebrolysin will be prescribed in a dose of 10 ml ampoule once daily through intramuscular injection (1ml contains 215.2 mg cerebrolysin) for five times per week, for a total of 20 treatments (for 4 weeks), after which the cycle was repeated again for at least 8 more weeks.
Other Name: Neurotropic factors
- 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. [ Time Frame: The within subject change in sniffin' sticks test between baseline and 12- and -24 assessment time frame ]The NHNES questions have been selected to characterize the variation, timing and associated-symptoms of both olfactory and gustatory systems. sniffin' sticks odor identification test, a total of 16 scents were presented via a pen device to patients for 3 seconds followed by a forced choice from 4 given options with a total possible score of 16 points. According to the results, patients were classified as normosmic (score between 12-16), hyposmic (score between 9-11) or anosmic (score 8 or below). The increase in at least 4 points from baseline indicates a clinically meaningful improvement. sniffin' sticks odor identification test has high internal reliability across a wide range of population.
- The short modified version of the Questionnaire of Olfactory Disorders-Negative Statements (sQOD-NS) [ Time Frame: The within subject chage in QOD-NS between baseline and assessment frame ]sQOD-NS is a seven-item patient-reported outcome questionnaire including social, eating, annoyance, and anxiety questions. Each item is rated on a scale of 0-3, with higher scores reflecting better olfactory-specific QOL. The total score ranges from 0 (severe impact on QoL) to 21 (no impact on QoL).
- The Globas Rating for smell (GRS) [ Time Frame: 6 weeks, 12 weeks, 18 weeks and 24 weeks ]GRS 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: 6 weeks, 12 weeks, 18 weeks and 24 weeks ]GRT 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830943
|Assiut University Hospitals, Faculty of Medicine|
|Assiut, Egypt, 71516|
|Principal Investigator:||Sherifa A Hamed, M.D.||Assiut University, Faculty of Medicine|