A Multi-Center, Individually-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Superiority Trial to Evaluate the Efficacy of the Combination of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Participation in another therapeutic clinical trial in the past 2 months.

2. History of allergy or anaphylaxis or allergic reaction to any component of atorvastatin and/or maraviroc.

3. Uncontrolled hypothyroidism as defined as thyroid-stimulating hormone (TSH) and/or free thyroxine (FT4) values outside the local laboratory reference range at screening, or a change in thyroid hormone replacement dose within 6 weeks prior to screening.

4. Pre-COVID history of autoimmune conditions, migraines, neuropathy, inflammatory bowel disease (IBD), obsessive-compulsive disorder (OCD), or fatigue duration for ≥5 years, EBV infection, Lyme disease, fibromyalgia, arthritis, chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD G3a or greater), chronic heart failure (CHF), arrhythmias, bleeding disorders, and anticoagulation therapy.

5. Presence of other conditions or differential diagnosis that better explains the symptoms of the patient than the suspected long COVID, in the opinion of the investigator.

6. Hepatic impairment, defined as Child-Pugh Score 7-9 (Class B) or greater.

7. Active/acute infectious diseases like tuberculosis, human immunodeficiency virus infection (HIV), cytomegalovirus (CMV), (vector based) Lyme, EBV, hepatitis B virus (HBV), hepatitis C virus (HCV).

8. Ongoing immunosuppressive therapy, such as cyclosporine A (CsA).

9. Use of statins within 6 months of randomization.

10. Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir, or lipid-modifying doses (\>1 gram/day) of niacin.

11. AST:ALT ratio\>1.5

12. Elevations in IL-8 (\>21 (pg/ml) and or IL-13 (\>6.1 pg/ml) (centrally assessed with IncellKINE panel).

13. Pregnant or breastfeeding

14. History of substance use disorder (including alcohol use disorder or cannabis use disorder per DSM-5 criteria) within 3 months of enrollment, OR current hazardous alcohol use as defined by:

* Self-reported consumption \>14 drinks/week (males) or \>7 drinks/week (females), OR

* Binge drinking (≥5 drinks on one occasion for males, ≥4 for females) ≥1 time per week, OR

* Clinical judgment that alcohol use would interfere with study compliance or safety

15. Subjects with risk factors for myocardial ischemia/infarction, including but not limited to those with a prior history of MI, stroke, unstable angina,

16. Any significant disease or disorder, which, in the opinion of the Investigator, may either put the participants at risk

17. Azole antifungals (ketoconazole or itraconazole are not allowed) or macrolide antibiotics (clarithromycin is not allowed)

18. History of use of maraviroc and/or atorvastatin for the off-label treatment of Long COVID.

Prohibited concomitant medications

19. Any statins within 6 months of randomization and between randomization and the participant's scheduled final visit

20. Other systemically administered drugs with significant immunosuppressive activity, such as azathioprine, tacrolimus, cyclosporine, methotrexate, or cytotoxic chemotherapy between randomization and the participant's scheduled final visit

21. Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:

1. clarithromycin

2. cobicistat

3. elvitegravir/ritonavir

4. itraconazole

5. ketoconazole

6. nefazodone

7. protease inhibitors (except tipranavir/ritonavir)

8. telithromycin

22. Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis:

1. cyclosporine or gemfibrozil

2. tipranavir plus ritonavir or glecaprevir plus pibrentasvir

3. niacin (≥1 gram/day niacin)

What this study is about