Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia (SimCA)
Olfactory Disorder, COVID-19
About this trial
This is an interventional treatment trial for Olfactory Disorder focused on measuring Olfactory Disorder, COVID-19
Eligibility Criteria
Inclusion Criteria:
- Males and females age 18-70 years old
- Diagnosis of COVID-19 at least 3 months prior to study enrollment, but no greater than 12 months prior to study.
- 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)
- 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
- Ability to read, write, and understand English
Exclusion Criteria:
- Olfactory loss prior to COVID-19 infection
History of conditions that impact olfactory function
- Chronic rhinosinusitis
- History of prior sinonasal or skullbase surgery
- Neurodegenerative disorders (Parkinson's disease, Huntington's disease, Amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal dementia)
- Current or recent (within 8 weeks of study enrollment) oral statin use
History of conditions that increase risks of statin intolerance
- Untreated hypothyroidism
- History of chronic kidney disease or abnormal renal function at the time of enrollment
- Personal or family history of myositis or elevated creatine kinase at the time of enrollment
- Alcohol consumption greater than 7 drinks per week (female) or 14 drinks per week (male)
- History of liver disease or elevated liver enzymes at the time of enrollment
- History of statin intolerance
- Human immunodeficiency virus
- Viral hepatitis
History indicating that the subject should receive oral statins
- Angina
- Myocardialinfarction
- Cardiac surgery in the last 2 years
- Elevated total cholesterol at baseline
- History of malignancy
- History of statin intolerance
- Currently pregnant or nursing
Use of any medications contraindicated with statins
- Antiviral protease inhibitors
- Macrolides
- Antifungals
- Cyclosporine
- Calcium channel blockers
- Diltiazem
- Danazole
- Amiodarone
- Gemfibrozil
- Nefazodone
- Ingestion of >1 quart of grapefruit juice per day
- Digoxin
- Niacin
- Coumadin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
topical nasal simvastatin - 0.1 mg dose
topical nasal simvastatin - 0.25 mg dose
topical nasal simvastatin - 0.5 mg dose
topical nasal simvastatin - 1 mg dose
topical nasal simvastatin - 0.1 mg dose Subjects are entered into the study in groups of 3. This first cohort will receive the lowest dose of simvastatin (0.1mg) 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. If >2 of the 3 subjects enrolled in the first group report toxicity then the dose is considered toxic or "MTD is exceeded." If 1 of the first 3 reports toxicity, then the next group of 3 enrolled subjects will receive the same dose as group 1. When 6 subjects receive the same dose, and <1 of them report toxicity, the consecutive group of 3 subjects will receive the successive higher dose. If >2 of the 6 subjects on the same dose report toxicities, then MTD is exceeded. Intra-patient dose escalation will not be performed.
topical nasal simvastatin - 0.25 mg dose Subjects are entered into the study in groups of 3. This 2nd cohort will receive the 0.25mg simvastatin 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. If >2 of the 3 subjects enrolled in the first group report toxicity then the dose is considered toxic or "MTD is exceeded." If 1 of the first 3 reports toxicity, then the next group of 3 enrolled subjects will receive the same dose as group 1. When 6 subjects receive the same dose, and <1 of them report toxicity, the consecutive group of 3 subjects will receive the successive higher dose. If >2 of the 6 subjects on the same dose report toxicities, then MTD is exceeded. Intra-patient dose escalation will not be performed.
topical nasal simvastatin - 0.5 mg dose Subjects are entered into the study in groups of 3. This 3rd cohort will receive the 0.5mg simvastatin 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. If >2 of the 3 subjects enrolled in the first group report toxicity then the dose is considered toxic or "MTD is exceeded." If 1 of the first 3 reports toxicity, then the next group of 3 enrolled subjects will receive the same dose as group 1. When 6 subjects receive the same dose, and <1 of them report toxicity, the consecutive group of 3 subjects will receive the successive higher dose. If >2 of the 6 subjects on the same dose report toxicities, then MTD is exceeded. Intra-patient dose escalation will not be performed.
topical nasal simvastatin - 1 mg dose Subjects are entered into the study in groups of 3. This 4th cohort will receive the 1mg simvastatin via nasal irrigation for 4 weeks. If none of the 3 subjects report toxicity, then the drug will be considered tolerated at the maximum tested dose. If >2 of the 3 subjects enrolled in the first group report toxicity then the dose is considered toxic or "MTD is exceeded." If 1 of the first 3 reports toxicity, then the next group of 3 enrolled subjects will receive the same dose as group 1. When 6 subjects receive the same dose, and <1 of them report toxicity, then this maximum dose is considered tolerable. If >2 of the 6 subjects on the same dose report toxicities, then MTD is exceeded. Intra-patient dose escalation will not be performed.