COVID-19 Anosmia Study

NCT04495816 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GCO 20-1132
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Anosmia; Covid19

Keywords

Novel Coronavirus; Anosmia; Smell Loss; Parosmia; Fish Oil Supplement; Omega-3 Fatty Acid Supplements

Outcome Measures

Primary Outcomes (4)

• Change in Brief Smell Identification Test (BSIT)

  Change in BSIT. Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.

  Week 0 and Week 6

• Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory Dysfunction

  Mean change in BSIT in participants with severe olfactory dysfunction defined as BSIT ≤ 7. Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.

  Week 0 and Week 6

• Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory Dysfunction

  Mean change in BSIT in participants with laboratory-confirmed COVID-19. Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.

  Week 0 and Week 6

• Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19

  Mean change in BSIT in participants with severe olfactory dysfunction defined as BSIT ≤ 6. Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.

  Week 0 and Week 6

Secondary Outcomes (2)

• Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS)

  baseline, weeks 1, 2, 4 and 6 after softgel initiation

• Sinonasal Outcomes Test (SNOT-22)

  baseline, weeks 1, 2, 4 and 6 after softgel initiation

Study Arms (2)

Omega-3

ACTIVE COMPARATOR

1,000 mg of omega-3 fatty acid (2 softgels per day for 6 weeks)

Drug: Omega-3 Fatty Acid Supplement

Placebo/Control

SHAM COMPARATOR

2 softgels per day for 6 weeks

Drug: Placebo/Control

Interventions

Omega-3 Fatty Acid Supplement DRUG

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

Omega-3

Placebo/Control DRUG

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.

Placebo/Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years of age or older) with self-reported new-onset olfactory dysfunction

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (16)

• Vaira LA, Salzano G, Deiana G, De Riu G. Anosmia and Ageusia: Common Findings in COVID-19 Patients. Laryngoscope. 2020 Jul;130(7):1787. doi: 10.1002/lary.28692. Epub 2020 Apr 15.

  PMID: 32237238 BACKGROUND

• Fonteyn S, Huart C, Deggouj N, Collet S, Eloy P, Rombaux P. Non-sinonasal-related olfactory dysfunction: A cohort of 496 patients. Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Apr;131(2):87-91. doi: 10.1016/j.anorl.2013.03.006. Epub 2014 Mar 26.

  PMID: 24679542 BACKGROUND

• Hendriks AP. Olfactory dysfunction. Rhinology. 1988 Dec;26(4):229-51.

  PMID: 3070710 BACKGROUND

• Eliezer M, Hautefort C, Hamel AL, Verillaud B, Herman P, Houdart E, Eloit C. Sudden and Complete Olfactory Loss of Function as a Possible Symptom of COVID-19. JAMA Otolaryngol Head Neck Surg. 2020 Jul 1;146(7):674-675. doi: 10.1001/jamaoto.2020.0832. No abstract available.

  PMID: 32267483 BACKGROUND

• Croy I, Nordin S, Hummel T. Olfactory disorders and quality of life--an updated review. Chem Senses. 2014 Mar;39(3):185-94. doi: 10.1093/chemse/bjt072. Epub 2014 Jan 15.

  PMID: 24429163 BACKGROUND

• Reden J, Herting B, Lill K, Kern R, Hummel T. Treatment of postinfectious olfactory disorders with minocycline: a double-blind, placebo-controlled study. Laryngoscope. 2011 Mar;121(3):679-82. doi: 10.1002/lary.21401. Epub 2011 Feb 1.

  PMID: 21287560 BACKGROUND

• Vukkadala N, Qian ZJ, Holsinger FC, Patel ZM, Rosenthal E. COVID-19 and the Otolaryngologist: Preliminary Evidence-Based Review. Laryngoscope. 2020 Nov;130(11):2537-2543. doi: 10.1002/lary.28672. Epub 2020 Apr 24.

  PMID: 32219846 BACKGROUND

• Ekstrom I, Sjolund S, Nordin S, Nordin Adolfsson A, Adolfsson R, Nilsson LG, Larsson M, Olofsson JK. Smell Loss Predicts Mortality Risk Regardless of Dementia Conversion. J Am Geriatr Soc. 2017 Jun;65(6):1238-1243. doi: 10.1111/jgs.14770. Epub 2017 Mar 22.

  PMID: 28326534 BACKGROUND

• Sorokowska A, Drechsler E, Karwowski M, Hummel T. Effects of olfactory training: a meta-analysis. Rhinology. 2017 Mar 1;55(1):17-26. doi: 10.4193/Rhino16.195.

  PMID: 28040824 BACKGROUND

• Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.

  PMID: 32253535 BACKGROUND

• Cavazzana A, Larsson M, Munch M, Hahner A, Hummel T. Postinfectious olfactory loss: A retrospective study on 791 patients. Laryngoscope. 2018 Jan;128(1):10-15. doi: 10.1002/lary.26606. Epub 2017 May 29.

  PMID: 28556265 BACKGROUND

• Pekala K, Chandra RK, Turner JH. Efficacy of olfactory training in patients with olfactory loss: a systematic review and meta-analysis. Int Forum Allergy Rhinol. 2016 Mar;6(3):299-307. doi: 10.1002/alr.21669. Epub 2015 Dec 1.

  PMID: 26624966 BACKGROUND

• Boesveldt S, Postma EM, Boak D, Welge-Luessen A, Schopf V, Mainland JD, Martens J, Ngai J, Duffy VB. Anosmia-A Clinical Review. Chem Senses. 2017 Sep 1;42(7):513-523. doi: 10.1093/chemse/bjx025.

  PMID: 28531300 BACKGROUND

• Reden J, Mueller A, Mueller C, Konstantinidis I, Frasnelli J, Landis BN, Hummel T. Recovery of olfactory function following closed head injury or infections of the upper respiratory tract. Arch Otolaryngol Head Neck Surg. 2006 Mar;132(3):265-9. doi: 10.1001/archotol.132.3.265.

  PMID: 16549746 BACKGROUND

• Damm M, Pikart LK, Reimann H, Burkert S, Goktas O, Haxel B, Frey S, Charalampakis I, Beule A, Renner B, Hummel T, Huttenbrink KB. Olfactory training is helpful in postinfectious olfactory loss: a randomized, controlled, multicenter study. Laryngoscope. 2014 Apr;124(4):826-31. doi: 10.1002/lary.24340. Epub 2013 Sep 19.

  PMID: 23929687 BACKGROUND

• Lerner D, Garvey K, Arrighi-Allisan A, Filimonov A, Filip P, Liu K, Ninan S, Schaberg M, Colley P, Del Signore A, Govindaraj S, Iloreta AM. Letter to the editor: Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction. Trials. 2020 Nov 23;21(1):942. doi: 10.1186/s13063-020-04905-y.

  PMID: 33225989 DERIVED

MeSH Terms

Conditions

Anosmia; COVID-19; Olfaction Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. David Lerner
• Organization: Icahn School of Medicine at Mount Sinai

david.lerner2@mountsinai.org

212-241-9410

Study Officials

• Alfred-Marc Iloreta, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 3, 2020
• Study Start: July 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 23, 2023
• Results First Posted: January 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)