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NCT05542095: SimCA
Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia
Phase 1 trial testing Simvastatin in Olfactory Disorder. Withdrawn.
1 May 2023
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 May 2023 |
| Primary completion | 1 May 2023 |
| Estimated completion | 1 May 2023 |
Drugs / interventions tested
- Simvastatin (simvastatin) — full drug profile →
Conditions studied
- Olfactory Disorder — all drugs for Olfactory Disorder →
- COVID-19 — all drugs for COVID-19 →
Sponsor
Washington University School of Medicine
Who can join
Adults 18 to 70, any sex, with Olfactory Disorder or COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Olfactory dysfunction (OD) or changes in smell and/or taste is one of the cardinal presenting symptoms of COVID-19. Despite the prevalence of COVID and resultant OD, the pathophysiology of COVID-mediated OD is not fully understood, but recent evidence indicates that local inflammatory and oxidative injury play a major role. This phase 1 safety trial evaluates the use of simvastatin nasal irrigations for the management of COVID-mediated OD. We will determine the maximum tolerable dose and evaluate the safety and tolerability of high-volume simvastatin nasal irrigations in subjects with persistent COVID-mediated OD. Each subject will complete bloodwork at baseline and then at the completion of their participation in the study. During this trial, we will observe olfactory function for each participant at baseline and completion of this study via the University of Pennsylvania Smell Identification Test (UPSIT). Investigational product will be shipped directly to the subject for daily irrigation each day for 4 weeks. Weekly throughout the study for a total of 4 weeks, subjects will complete the Sino-Nasal Outcome Test-22. The current study would provide the support for Phase II and III clinical trials. Additionally, the study has applications for other disease processes affecting the sinonasal cavities.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Metabolic alterations upon SARS-CoV-2 infection and potential therapeutic targets against coronavirus infection.
Chen P, Wu M, He Y, Jiang B, et al · · 2023 · cited 50× · PMID 37286535 · DOI 10.1038/s41392-023-01510-8
Verify or expand the search:
- PubMed search for NCT05542095
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Olfactory Disorder
Currently open trials in the same condition.
- NCT05855369 — Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID) · Phase 2, PHASE3 · recruiting
- NCT06456008 — Prospective Registery of Smell/Taste Clinic Ear/Nose/Throat · recruiting
- NCT04869436 — Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis · Phase 4 · recruiting
- NCT04791436 — Oral and Olfactory Complications of Recovered COVID-19 Patients · recruiting
Other Washington University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05542095 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 12 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05542095.
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