NCT04422275: Co-STAR

Coronavirus Smell Therapy for Anosmia Recovery

Withdrawn Phase 2 Last updated 2 March 2021

What this trial tests

Phase 2 trial testing Budesonide in Anosmia. Withdrawn.

Timeline

1 June 2021

Primary endpoint
1 June 2023

31 December 2023

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Start date	1 June 2021
Primary completion	1 June 2023
Estimated completion	31 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Budesonide (BUDESONIDE) — full drug profile →
• High-Concentration Essential Oil
• Placebo
• Low-Concentration Essential Oil

Conditions studied

• Anosmia — all drugs for Anosmia →

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 85, any sex, with Anosmia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction.
   Webster KE, O'Byrne L, MacKeith S, Philpott C, et al · · 2021 · cited 22× · PMID 34291812 · DOI 10.1002/14651858.cd013877.pub2
2. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction.
   O'Byrne L, Webster KE, MacKeith S, Philpott C, et al · · 2022 · cited 21× · PMID 36062970 · DOI 10.1002/14651858.cd013876.pub3
3. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction.
   O'Byrne L, Webster KE, MacKeith S, Philpott C, et al · · 2021 · cited 21× · PMID 34291813 · DOI 10.1002/14651858.cd013876.pub2
4. Repurpose but also (nano)-reformulate! The potential role of nanomedicine in the battle against SARS-CoV2.
   Tammam SN, El Safy S, Ramadan S, Arjune S, et al · · 2021 · cited 13× · PMID 34293319 · DOI 10.1016/j.jconrel.2021.07.028
5. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction.
   Webster KE, O'Byrne L, MacKeith S, Philpott C, et al · · 2022 · cited 11× · PMID 36063364 · DOI 10.1002/14651858.cd013877.pub3
6. Post Viral Olfactory Dysfunction After SARS-CoV-2 Infection: Anticipated Post-pandemic Clinical Challenge.
   Kapoor D, Verma N, Gupta N, Goyal A. · · 2022 · cited 7× · PMID 34249668 · DOI 10.1007/s12070-021-02730-6
7. Neurological manifestations of COVID-19: A brief review.
   Sachdev K, Agrawal S, Ish P, Gupta N, et al · · 2020 · cited 7× · PMID 32859864 · DOI 10.4103/ijmr.ijmr_1395_20