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).
Letter to the editor: Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction