Olfactory and Neurosensory Rehabilitation in COVID-19-related Olfactory Dysfunction

NCT04900415 | Unknown Phase 2 DMC

• 1 other identifier: UW 20-454
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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).

Conditions

Coronavirus Disease 2019

Keywords

Vitamin A; Smell training; COVID-19; Olfactory dysfunction; Anosmia; Functional MRI

Outcome Measures

Primary Outcomes (3)

• Subjective olfactory assessment

  Subjective olfactory assessment by the Sino-Nasal Outcome Test (SNOT-22).

  4 weeks

• Objective olfactory assessment by the butanol threshold test (BTT)

  Objective measurements of olfactory sensitivity, as determined by the detection of different concentrations of butanol.

  4 weeks

• Objective olfactory assessment by the smell identification test (SIT)

  Objective categorization of olfactory status by the smell identification test (SIT).

  4 weeks

Secondary Outcomes (5)

• Interim neuroradiological changes after 2 weeks of olfactory treatment

  2 weeks

• Neuroradiological changes after olfactory treatment at the end of study

  4 weeks

• Interim neuroradiological changes after oral vitamin A in combination with smell training versus smell training alone

  2 weeks

• Neuroradiological brain changes in the intervention group versus observation group at the end of study

  4 weeks

• Neuroradiological brain changes in the intervention group versus healthy control group at the end of study

  4 weeks

Study Arms (3)

Vitamin A and smell training

EXPERIMENTAL

14-day course of daily oral vitamin A 7500µg RAE in combination with smell training three times per day for 4 weeks

Drug: Vitamin A; Device: Electronic portable aromatic rehabilitation (EPAR) diffuser

Smell training

ACTIVE COMPARATOR

Smell training three times per day for 4 weeks

Device: Electronic portable aromatic rehabilitation (EPAR) diffuser

Control

NO INTERVENTION

Observation

Interventions

Vitamin A DRUG

Metabolic supplement for neurogenesis at the olfactory apparatus

Vitamin A and smell training

Electronic portable aromatic rehabilitation (EPAR) diffuser DEVICE

Handheld essential oil ultrasonication diffuser technology

Smell training; Vitamin A and smell training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ivan FN Hung MD: lead
• Pamela Youde Nethersole Eastern Hospital: collaborator

Study Sites (2)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

RECRUITING

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

COVID-19; Anosmia

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Central Study Contacts

Ivan Fan Ngai Hung, MD

CONTACT

22554049; ivanhung@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study participants will receive baseline and follow up resting-state functional (rs-fMRI) brain scans during the study period. The radiologists assessing and analysing the rs-fMRI images will be blinded to the treatment regimens received by the study subjects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Patients with prolonged COVID-19-related olfactory dysfunction will be assigned to the intervention (group A or B) or control (group C) arms: Intervention arm A. 14-day course of daily oral vitamin A 7500µg RAE (retinol activity equivalents) in combination with smell training three times per day for 4 weeks; or B. Smell training three times per day for 4 weeks alone; or Control arm C. Observation

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 25, 2021
• Study Start: July 22, 2020
• Primary Completion: March 12, 2021
• Study Completion: June 30, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)