Abstract
Objectives
To evaluate a therapeutic role for omega-3 fatty acid supplementation in the treatment of olfactory dysfunction associated with COVID-19 infection
Trial design
Randomized, double-blinded, placebo-controlled trial
Participants
Eligible patients are adults with self-reported new-onset olfactory dysfunction of any duration associated with laboratory-confirmed or clinically suspected COVID-19 patients. Exclusion criteria include patients with pre-existing olfactory dysfunction, history of chronic rhinosinusitis or history of sinus surgery, current use of nasal steroid sprays or omega-3 supplementation, fish allergy, or inability to provide informed consent for any reason. The trial is conducted at Mount Sinai Hospital
Intervention and comparator
The intervention group will receive 2000 mg daily of omega-3 supplementation in the form of two “Fish Oil, Ultra Omega-3” capsules (product of Pharmavite®) daily. The comparator group will take 2 placebo capsules of identical size, shape, and odor daily for 6 weeks.
Main outcomes
Each subject will take a Brief Smell Identification Test at study enrolment and completion after 6 weeks. The primary outcome will be change in Brief Smell Identification Test over the 6-week period.
Randomisation
Patients will be randomized by the Investigational Drug Pharmacy at the Icahn School of Medicine at Sinai via a computer-generated sequence in a 1:1 allocation to treatment or control arms.
Blinding (masking)
Both participants and researchers will be blinded.
Numbers to be randomised (sample size)
There will be 88 participants randomized to each group. A total of 176 participants will be randomized.
Trial Status
Protocol Version 1, 8/3/2020
Recruitment is ongoing, started 8/5/2020 with estimated completion 11/30/2020.
Trial registration
The trial is registered on ClinicalTrials.gov with Protocol Identifier: NCT04495816.
Trial registration: ClinicalTrials.gov, NCT04495816. Registered 3 August 2020
Full protocol
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
Keywords: COVID-19, Randomised controlled trial, protocol, olfactory dysfunction, omega-3 fatty acid, smell loss
Supplementary Information
Acknowledgements
Not applicable.
Authors’ contributions
DL, AF, PF – study design, subject recruitment. KG, AA, KL, SN – subject recruitment, literature review. MS, PC, AS, SG – study design, subject recruitment. AI – study design, study oversight. The author(s) read and approved the final manuscript.
Funding
No funding was received for this study. Study drug and capsules were provided by Pharmavite®. Pharmavite® had no role in the design of the study and collection, analysis and interpretation of data and in the writing of the manuscript.
Availability of data and materials
The final trial dataset will be accessible from the author on reasonable request. Contact David Lerner (e-mail david.lerner2@mountsinai.org).
Ethics approval and consent to participate
This study protocol was approved by the Institutional Review Board at the Icahn School of Medicine at Mount Sinai on 7/10/2020 (HS#:20-00511, GCO#20-1132 ISMMS).
Informed consent will be obtained from all participants. Only adults are included in the study.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Footnotes
Publisher’s Note
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Supplementary Information
The online version contains supplementary material available at 10.1186/s13063-020-04905-y.
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The final trial dataset will be accessible from the author on reasonable request. Contact David Lerner (e-mail david.lerner2@mountsinai.org).