Status:
UNKNOWN
Olfactory and Neurosensory Rehabilitation in COVID-19-related Olfactory Dysfunction
Lead Sponsor:
Ivan FN Hung MD
Collaborating Sponsors:
Pamela Youde Nethersole Eastern Hospital
Conditions:
Coronavirus Disease 2019
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A combination of oral vitamin A (VitA) and intense aromatic chemosensory smell training (ST) by pulse aromatic stimulation will expedite the neurosensory recovery of olfaction in patients suffering fr...
Detailed Description
This is an open-labeled randomised-controlled trial (RCT) investigating the safety and therapeutic efficacy of oral VitA in combination with ST for patients suffering from prolonged COVID-19-related O...
Eligibility Criteria
Inclusion
- Adult out-patient (≥18 years of age)
- Previously diagnosed with coronavirus disease 2019 (COVID-19) by laboratory confirmation using reverse transcriptase polymerase chain reaction (RT-PCR) for the detection of severe acute respiratory virus coronavirus 2 (SARS-CoV-2)
- Complaints of persistent olfactory disturbances, subjectively
- Quantitatively documented to have olfactory dysfunction by
- Butanol threshold test (BTT)
- Smell identification test (SIT)
- All subjects give written informed consent
- Subjects must be available to complete the study and comply with study procedures.
Exclusion
- Inability to comprehend and to follow all required study procedures
- Allergy or severe reactions to the study drug or smell training
- Pregnant or breastfeeding women
- Pre-existing factors which may account for persistent olfactory dysfunction besides COVID-19 (e.g. nasal polyps, obstructive lesions within the nasal cavity, severe anatomical malformations…)
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to recruitment in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.
- Have any condition that the investigator believes may interfere with successful completion of the study.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04900415
Start Date
July 22 2020
End Date
June 30 2021
Last Update
May 25 2021
Active Locations (2)
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1
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
2
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong