COVID-19 Anosmia Study
Condition: Anosmia; Covid19
MeSH terms: COVID-19; Anosmia
Intervention: Omega-3 Fatty Acid Supplement; Placebo/Control
Intervention description: Participants randomized to this arm will be instructed to take two of the softgels they received per day for 6 weeks. They will receive softgels containing 1,000 mg of omega-3 fatty acid. 1000 mg of omega-3 fatty acid blend including 683 mg Eicosapentaenoic Acid and 252 mg Docosahexaenoic Acid; Patients randomized to this arm will also be instructed to take two of the softgels they received per day for 6 weeks. They will receive placebo softgels that are indistinguishable from those containing fish oil.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into treatment and control groups. The treatment group will receive omega-3-fatty acid supplementation (1000 mg of omega-3 fatty acid blend including 683 mg Eicosapentaenoic Acid and 252 mg Docosahexaenoic Acid) to be taken twice daily for 6 weeks. The control arm will receive a placebo pill to be taken twice daily.
Masking: Double (Participant, Investigator)
Masking description: The healthcare providers interacting with the patients, as well as the participants themselves, will not know which arm they have been assigned to. Only the research fellows will have access to the randomization scheme.
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Novel Coronavirus; Anosmia; Smell Loss; Parosmia; Fish Oil Supplement; Omega-3 Fatty Acid Supplements

Summary:

      To capture the natural history of COVID-19 associated olfactory dysfunction as measured by
      two patient reported outcome measures (SNOT-22, QOD-NS) and a 6-week BSIT with a comparison
      to an intervention arm receiving daily omega-3 supplements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (18 years of age or older) with self-reported new-onset olfactory dysfunction

          -  Positive COVID-19 diagnosis will be deemed eligible for inclusion.

        Exclusion Criteria:

          -  Patients <18 years of age

          -  Patients who are unable to provide informed consent

          -  Patients without a positive COVID-19 PCR result obtained through nasopharyngeal swab -
             Patients with a COVID-19 diagnosis but without self-reported anosmia

          -  Patients with severe COVID-19 disease as defined by the Mouth Sinai Health System
             Treatment Guidelines for SARS-COV-2 (requiring high flow nasal cannula,
             non-rebreather, CPAP/BIPAP, or mechanical ventilation OR patients requiring pressor
             medication OR patients with evidence of end organ damage)

          -  Patients with pre-existing self-reported olfactory dysfunction

          -  Patients with a history of chronic nasal/sinus infections (rhinosinusitis) or history
             of endoscopic sinus surgery

          -  Patients using nasal steroid sprays or irrigations for any reason

          -  Patients who are prisoners of the state

          -  Patients who have psychiatric or developmental disorder conditions that may impair
             ability to provide informed consent

          -  Patients will also be excluded if they have an allergy to fish or an omega-3
             supplement, or do not eat fish or fish- containing substances for any reason