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

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).

Long‐term upper aerodigestive sequelae as a result of infection with COVID‐19

“…Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2, colloquially referred to as COVID‐19) has now been demonstrated to affect all major organ systems 1–6 . The upper respiratory tract, which is considered a unified airway with the lower respiratory tract, serves as the initial nidus for SARS‐CoV‐2 infections and has been well‐demonstrated by the now commonly known symptoms of anosmia, hyposmia, phantosmia, and dysgeusia 7–9 . The term “long COVID” has been devised to refer to the profound, enduring effects of COVID infections on those who survive the acute, and often harrowing, stages of the disease 10 .…”

“…[1][2][3][4][5][6] The upper respiratory tract, which is considered a unified airway with the lower respiratory tract, serves as the initial nidus for SARS-CoV-2 infections and has been welldemonstrated by the now commonly known symptoms of anosmia, hyposmia, phantosmia, and dysgeusia. [7][8][9] The term "long COVID" has been devised to refer to the profound, enduring effects of COVID infections on those who survive the acute, and often harrowing, stages of the disease. 10 Interestingly, in the chronic, long-haul population, evidence is mounting that patients are commonly presenting with laryngological complaints to their health care providers.…”

Investigating Lipid-Modulating Agents for Prevention or Treatment of COVID-19

“…Factors such as number of enrollees, comparator types, blinding, type of primary outcomes (clinical or surrogate outcomes), blinded outcome adjudication, and the existence of published design paper are included. For 7 studies, a design paper or study protocol was available ( 12 , 13 , 14 , 15 , 16 , 17 , 18 ). Of all RCTs, only 1 has reported the results (at the National Lipid Association Virtual Scientific Sessions) ( 19 ).…”

“…Omega-3 fatty acid preparations are being evaluated in 4 ongoing RCTs for the treatment of COVID-19: KONS-COVID19 (Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19), VASCEPA-COVID-19 (An Investigation on the Effects of Icosapent Ethyl [Vascepa] on Inflammatory Biomarkers in Individuals With COVID-1), PREPARE-IT 2 (Prevention of COVID19 With EPA in Healthcare Providers at Risk–Intervention Trial 2), and the COVID-19 Anosmia Study ( NCT04495816 ) ( 16 ).…”

Lipid-Modulating Agents for Prevention or Treatment of COVID-19 in Randomized Trials

“…Omega-3 fatty acid preparations are being evaluated in 4 ongoing RCTs for treatment of COVID-19: KONS-COVID19 (Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19), VASCEPA-COVID-19 (An Investigation on the Effects of Icosapent Ethyl (Vascepa TM ) on Inflammatory Biomarkers in Individuals With COVID-1), PREPARE-IT 2 (Prevention of COVID19 With EPA in Healthcare Providers at Risk - Intervention Trial 2) and COVID-19 Anosmia Study (NCT04495816) (16).…”