COVID-19 Clinical Trial
— SimCAOfficial title:
Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia
NCT number | NCT05542095 |
Other study ID # | SimCA Trial |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | May 1, 2023 |
Verified date | May 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Males and females age 18-70 years old 2. Diagnosis of COVID-19 at least 3 months prior to study enrollment, but no greater than 12 months prior to study. 3. Objective olfactory dysfunction, believed to be due to COVID-19, that has persisted despite viral recovery otherwise (initial score on the UPSIT consistent with decreased olfactory function (<= 34 in women, <=33 in men) 4. Not currently using concomitant therapies specifically for the treamtment of OD, or willing to discontinue other therapies for the treatment of OD for the duration of the trial 5. Ability to read, write, and understand English Exclusion Criteria: 1. Olfactory loss prior to COVID-19 infection 2. History of conditions that impact olfactory function 1. Chronic rhinosinusitis 2. History of prior sinonasal or skullbase surgery 3. Neurodegenerative disorders (Parkinson's disease, Huntington's disease, Amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal dementia) 3. Current or recent (within 8 weeks of study enrollment) oral statin use 4. History of conditions that increase risks of statin intolerance 1. Untreated hypothyroidism 2. History of chronic kidney disease or abnormal renal function at the time of enrollment 3. Personal or family history of myositis or elevated creatine kinase at the time of enrollment 4. Alcohol consumption greater than 7 drinks per week (female) or 14 drinks per week (male) 5. History of liver disease or elevated liver enzymes at the time of enrollment 6. History of statin intolerance 7. Human immunodeficiency virus 8. Viral hepatitis 5. History indicating that the subject should receive oral statins 1. Angina 2. Myocardialinfarction 3. Cardiac surgery in the last 2 years 4. Elevated total cholesterol at baseline 6. History of malignancy 7. History of statin intolerance 8. Currently pregnant or nursing 9. Use of any medications contraindicated with statins 1. Antiviral protease inhibitors 2. Macrolides 3. Antifungals 4. Cyclosporine 5. Calcium channel blockers 6. Diltiazem 7. Danazole 8. Amiodarone 9. Gemfibrozil 10. Nefazodone 11. Ingestion of >1 quart of grapefruit juice per day 12. Digoxin 13. Niacin 14. Coumadin |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Duke University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and feasibility of simvastatin nasal wash | Primary objective is to evaluate safety and feasibility of simvastatin nasal wash.
Successive cohorts of 3 subjects will be enrolled until dose-limiting toxicities (DLT; defined as the development of statin intolerance with liver toxivity or muscle toxicity as determined by elevated AST, ALT, or CK or the development of significant systemic or sinonasal symptoms requiring drug discontinuation) are observed in greater than 33% of the enrolled subjects. We will monitor for signs or symptoms of toxicity. Weekly throughout the study, subjects will complete the SNOT-22. The absolute change in SNOT-22 scores from baseline will be utilized to describe any adverse effects of simvastatin rinses on sinonasal function and quality of life. Nasal endoscopy will be performed at the time of enrollment and at study completion to ensure no local tissue effects of topical simvastatin rinses. A Lund-Kennedy score reflecting sinonasal disease severity will be noted at the time of nasal endoscopy. |
4 weeks | |
Secondary | Maximum tolerable dose of simvastatin nasal rinses via a dose escalation trial. | The secondary goal of this study is to determine the maximum tolerable dose of simvastatin nasal rinses via a dose-escalation trial. The first cohort will receive the lowest dose of simvastatin (0.1 mg) via nasal irrigation for 4 weeks. If none of the 3 subjects report toxicity, the next group of 3 subjects enrolled will receive the consecutive higher dose of simvastatin for 1 month to a maximum dose of (1mg). We plan to test the following doses: 0.1 mg, 0.25 mg, 0.5 mg, 1 mg.
Subjects will complete the SNOT-22 weekly. The absolute change in SNOT-22 scores from baseline will be utilized to describe any adverse effects of simvastatin rinses on sinonasal function and quality of life. Nasal endoscopy will be performed within 6 months of enrollment and at study completion to ensure no local tissue effects of topical simvastatin rinses. A Lund-Kennedy score, which reflect sinonasal disease severity, will be noted at the time of nasal endoscopy. |
4 weeks |
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