Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900415
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2021-05-17
Brief Title:
Olfactory and Neurosensory Rehabilitation in COVID-19-related Olfactory Dysfunction
Sponsor:
Ivan FN Hung MD
Organization:
The University of Hong Kong
Study Overview
Official Title:
Olfactory and Neurosensory Rehabilitation in Coronavirus 2019 COVID-19-Related Olfactory Dysfunction OD
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 from prolonged COVID-19-related olfactory dysfunction OD
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 OD
Prior to the initiation of treatment all patients will receive subjective and objective olfactory assessments Comprehensive ear nose and throat ENT examination will be performed to rule out alternative causes of OD All participants will receive resting-state functional magnetic resonance imaging rs-fMRI of the brain before treatment as baseline evaluation
Patients with prolonged COVID-19-related OD will be assigned to the intervention group A or B or control group C arms
Intervention arm A 14-day course of daily oral VitA 7500µg RAE retinol activity equivalents in combination with ST three times per day for 4 weeks or B ST three times per day for 4 weeks alone or
Control arm C Observation
In addition healthy controls who were tested negative for SARS-CoV-2 by reverse transcription polymerase chain reaction RT-PCR will receive rs-fMRI brain scans for radiological comparisons
At the completion of the trial subjective and objective olfactory assessments will be repeated to document clinical changes in olfaction Follow-up rs-fMRI will be performed to document neuroradiological changes in the brain structures and cerebral network functional connectivity FC
Prior to the initiation of treatment all patients will receive subjective and objective olfactory assessments Comprehensive ear nose and throat ENT examination will be performed to rule out alternative causes of OD All participants will receive resting-state functional magnetic resonance imaging rs-fMRI of the brain before treatment as baseline evaluation
Patients with prolonged COVID-19-related OD will be assigned to the intervention group A or B or control group C arms
Intervention arm A 14-day course of daily oral VitA 7500µg RAE retinol activity equivalents in combination with ST three times per day for 4 weeks or B ST three times per day for 4 weeks alone or
Control arm C Observation
In addition healthy controls who were tested negative for SARS-CoV-2 by reverse transcription polymerase chain reaction RT-PCR will receive rs-fMRI brain scans for radiological comparisons
At the completion of the trial subjective and objective olfactory assessments will be repeated to document clinical changes in olfaction Follow-up rs-fMRI will be performed to document neuroradiological changes in the brain structures and cerebral network functional connectivity FC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None