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COVID-19 Anosmia Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495816
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Alfred-Marc Iloreta, Icahn School of Medicine at Mount Sinai

Brief 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.

Condition or disease Intervention/treatment Phase
Anosmia Covid19 Drug: Omega-3 Fatty Acid Supplement Drug: Placebo/Control Phase 2

Detailed Description:

Infection with the novel coronavirus (COVID-19) has been linked to new-onset olfactory dysfunction, often as the only presenting symptom. In one multicenter European study, 85.6% of patients with mild to moderate symptoms reported hyposmia or anosmia with early recovery of olfactory function in just under half of patients. However, the pathogenesis and natural history of COVID-19 related olfactory dysfunction is poorly understood.

Anosmia most commonly arises in association with sinonasal disease or post-infectious or post-traumatic disorders. Notably, olfactory loss has been associated with impaired quality of life, higher rates of depression, and even increased mortality risk. Spontaneous recovery has been observed in patients with post- infectious olfactory dysfunction, typically over a period of months to years, with an estimated one-third of patients demonstrating meaningful improvement after one year.

Smell retraining therapy appears to be an effective therapeutic option for patients with post-infectious olfactory dysfunction, particularly for patients who initiate treatment within one year from onset of symptoms, but requires an intervention period of at least three to four months. Various pharmacotherapies have been investigated in the treatment of post-infectious anosmia but none have clearly demonstrated utility with the exception of a possible benefit for nasal steroid irrigations in combination with smell retraining therapy.

More recently, omega-3 polyunsaturated fat supplementation has emerged as a promising pharmacotherapy for olfactory dysfunction in patients without sinonasal disease. Omega-3 fatty acid deficient mice demonstrate evidence of olfactory dysfunction and mice receiving omega-3 fatty acids have improved recovery after peripheral nerve injury, which has been linked to neuroprotective effects mediated through anti-oxidant and anti-inflammatory pathways. In humans, a large cross-sectional study found that older adults with higher dietary fat intake had lower incidence of olfactory impairment. From a clinical perspective, patients without sinonasal disease receiving postoperative omega-3 fatty acid supplementation after endoscopic endonasal skull base surgery in a randomized control trial demonstrated a significantly greater rate of return of normal olfactory dysfunction.

Little is known about either the natural history of olfactory dysfunction associated with COVID-19 infection or about the therapeutic efficacy of omega-3 fatty acid supplementation in patients with post-viral anosmia. The study team hopes to gain a better understanding of each through a randomized double-blind placebo control study that assesses both objective and subjective perception of olfactory dysfunction over a period of 6 weeks after infection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
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.
Primary Purpose: Treatment
Official Title: COVID-19 Anosmia Study
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Omega-3
1,000 mg of omega-3 fatty acid (2 softgels per day for 6 weeks)
Drug: Omega-3 Fatty Acid Supplement
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

Sham Comparator: Placebo/Control
2 softgels per day for 6 weeks
Drug: Placebo/Control
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.




Primary Outcome Measures :
  1. Brief Smell Identification Test (BSIT) [ Time Frame: Week 0 ]
    Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.

  2. Brief Smell Identification Test (BSIT) [ Time Frame: 6 weeks after beginning to take supplements ]
    Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.


Secondary Outcome Measures :
  1. Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS) [ Time Frame: 1 week after softgel initiation ]
    The modified Brief Questionnaire of Olfactory Dysfunction - Negative Statements (QOD-NS) survey is a 17-item instrument, each item graded on a scale from 0 to 3, with total scale range from 0 to 51. Higher score indicates better olfactory-specific quality of life (QOL).

  2. Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS) [ Time Frame: 2 weeks after softgel initiation ]
    The modified Brief Questionnaire of Olfactory Dysfunction - Negative Statements (QOD-NS) survey is a 17-item instrument, each item graded on a scale from 0 to 3, with total scale range from 0 to 51. Higher score indicates better olfactory-specific quality of life (QOL).

  3. Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS) [ Time Frame: 4 weeks after softgel initiation ]
    The modified Brief Questionnaire of Olfactory Dysfunction - Negative Statements (QOD-NS) survey is a 17-item instrument, each item graded on a scale from 0 to 3, with total scale range from 0 to 51. Higher score indicates better olfactory-specific quality of life (QOL).

  4. Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS) [ Time Frame: 6 weeks after softgel initiation ]
    The modified Brief Questionnaire of Olfactory Dysfunction - Negative Statements (QOD-NS) survey is a 17-item instrument, each item graded on a scale from 0 to 3, with total scale range from 0 to 51. Higher score indicates better olfactory-specific quality of life (QOL).

  5. Sinonasal Outcomes Test (SNOT-22) [ Time Frame: 1 week after softgel initiation ]
    Sino-Nasal Outcome Test (SNOT-22) is a 22-item instrument, total scale range from 0 to 110, higher score indicates more severe QOL impact.

  6. Sinonasal Outcomes Test (SNOT-22) [ Time Frame: 2 weeks after softgel initiation ]
    Sino-Nasal Outcome Test (SNOT-22) is a 22-item instrument, total scale range from 0 to 110, higher score indicates more severe QOL impact.

  7. Sinonasal Outcomes Test (SNOT-22) [ Time Frame: 4 weeks after softgel initiation ]
    Sino-Nasal Outcome Test (SNOT-22) is a 22-item instrument, total scale range from 0 to 110, higher score indicates more severe QOL impact.

  8. Sinonasal Outcomes Test (SNOT-22) [ Time Frame: 6 weeks after softgel initiation ]
    Sino-Nasal Outcome Test (SNOT-22) is a 22-item instrument, total scale range from 0 to 110, higher score indicates more severe QOL impact.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495816


Contacts
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Contact: Alfred-Marc Iloreta, MD 212-241-5944 alfred-marc.iloreta@mountsinai.org
Contact: David K Lerner, MD 513-379-2815 David.Lerner2@mountsinai.org

Locations
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United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Alfred-Marc Iloreta, MD    212-241-5944    alfred-marc.iloreta@mountsinai.org   
Contact: David K Lerner, MD    513-379-2815    david.lerner2@mountsinai.org   
Principal Investigator: Alfred-Marc Iloreta, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Alfred-Marc Iloreta, MD Icahn School of Medicine at Mount Sinai
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alfred-Marc Iloreta, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04495816    
Other Study ID Numbers: GCO 20-1132
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alfred-Marc Iloreta, Icahn School of Medicine at Mount Sinai:
Novel Coronavirus
Anosmia
Smell Loss
Parosmia
Fish Oil Supplement
Omega-3 Fatty Acid Supplements
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases