As the COVID-19 pandemic spread around the world, anosmia and dysgeusia were quickly
recognized as two of the key presenting symptoms. The probability of return of smell is
related to severity of smell loss at presentation, but it appears that the loss of sense of
smell and taste seems to persist in approximately 10% of the affected patients after 6
months. As a result of COVID-19, it is estimated that within the next 12 months > 150,000
Americans will suffer permanent loss of smell. The magnitude of this impairment on the
health, safety, and quality of life is truly unprecedented and makes post-COVID olfactory
disorder a major public health problem. Thus, there is a pressing need to identify effective
treatments.
The research questions are to determine the effects of steroid nasal saline lavage and
olfactory training among adults with post-COVID olfactory dysfunction and identify
confounders and modifiers of any observed effects. To answer the research question, the
investigators propose a 2 x 2 factorial design blinded randomized clinical trial whereby 220
subjects with documented COVID-19 with anosmia/hyposmia of 12 weeks duration or longer from
Missouri, Illinois, and Indiana will be recruited electronically from COVID patient advocacy
sites, social media sites, and other internet sources. Enrolled subjects will be randomized
to nasal saline lavage with topical budesonide or placebo to address the presumed role of
inflammation in the olfactory cleft and each subject will also be randomized to olfactory
training with patient-specific, high- or low-concentration essential oil scent to assess the
role of olfactory training. Data will be analyzed in a blinded fashion to allow estimation of
observed effect size for both anti-inflammatory and olfactory training.
This innovative study will exploit the unique opportunities presented by COVID-19. The study
will use a high-tech virtual "contactless" research strategy, including eConsent and digital
mHealth techniques to obtain rapid answers to the research questions. The interventions are
low-cost, readily available, and results of this study can be directly disseminated to the
care of COVID-19 patients with anosmia.