Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT05542095
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05542095
Study Brief:
Protocol Section:
NCT05542095