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Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia

NCT05542095 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-06-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Simvastatin

Compounded simvastatin that is suspended within a nasal saline irrigation will be utilized throughout this study. Participants will suspend the contents of the simvastatin capsules (0.1mg, 0.25 mg, 0.5 mg, and 1 mg) into the sinus rinse bottle containing nasal saline. All participants will receive an 8-ounce sinus rinse bottle and a 4-week supply of USP Grade Sodium Chloride \& Sodium Bicarbonate Mixture (pH balanced, Isotonic \& Preservative \& Iodine Free) commercially prepared packets. Participants will either need to purchase distilled water or boil tap water for five minutes for use with the saline irrigation.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Nyssa F Farrell, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-05-01
Completion
2023-05-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542095 on ClinicalTrials.gov