UMIN-CTR Clinical Trial

Basic information
Public title	Post COVID-19 Anosmia
Acronym	Anosmia
Scientific Title	Post COVID-19 Anosmia treatments
Scientific Title:Acronym	Anosmia treatments
Region	Africa

Condition
Condition	Anosmia
Classification by specialty	Medicine in general Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the role of the topical corticosteroid, antihistamines, nasal spray in the treatment of post-COVID-19 anosmia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Anosmia improvement that was measured by Butanol threshold test and discrimination test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination of local corticosteroids and antihistamines nasal spray
Interventions/Control_2	Local corticosteroids nasal spray
Interventions/Control_3	Antihistamines nasal spray
Interventions/Control_4	Normal saline 0.2%
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	All adults with post-COVID-19 smell dysfunction
Key exclusion criteria	We excluded patients who already used nasal or systemic steroids or with previous chronic rhinological pathologies, patients with anosmia improved before COVID-19 recovery, pregnant women, or patients who did not complete the follow-up period
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Asmaa Middle name Salah. Last name Mohamed
Organization	Derya university
Division name	Clinical pharmacy
Zip code	61516
Address	Minia, Egypt
TEL	01066953443
Email	asmaa.elsaddory@yahoo.com

Public contact
Name of contact person	1st name Hosam Middle name Mohammad Last name Ahmad
Organization	Egypt Ministry of Health and population
Division name	Internal Medicine and biomedical chemistry
Zip code	61516
Address	Minia, Egypt
TEL	01000638308
Homepage URL
Email	hosam.refaei@yahoo.com

Sponsor
Institute	Derya university, Minia university
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Deraya university
Address	Plot No 3 Ard El Gameaat, New Minya, Minya, Egypt
Tel	16283
Email	commuincation.center@deraya.edu.eg

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	"Derya University, Minia university hospital"

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 01 Month 01 Day
Date of IRB	2021 Year 01 Month 02 Day
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 05 Day
Last modified on	2021 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049715