CompletedPhase 2

COVID-19 Anosmia Study

United States139 participantsStarted 2020-07-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Brief Smell Identification Test (BSIT)

Timeframe: Week 0 and Week 6

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

Timeframe: Week 0 and Week 6

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

Timeframe: Week 0 and Week 6

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

Timeframe: Week 0 and Week 6

Trial details

NCT IDNCT04495816

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Results submitted2022-09-15

View on ClinicalTrials.gov More Anosmia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Brief Smell Identification Test (BSIT)

Timeframe: Week 0 and Week 6

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

Timeframe: Week 0 and Week 6

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

Timeframe: Week 0 and Week 6

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

Timeframe: Week 0 and Week 6