The IMPACT Long Covid Treatment clinical study (IMPACT-LC) is testing two repurposed andpreviously approved drugs, Maraviroc and Atorvastatin, for the treatment ofnon-hospitalized subjects with long COVID/Post-Acute Sequelae of COVID (PASC). The maingoals of the clinical study are to determine if this combination drug therapy can improveneurocognitive and physical functions in Long Covid patients, such as fatigue severity,heart rate, blood pressure, digestion, breathing, dizziness, and cognitive function. Asecondary goal is to determine if biomarker levels, measured by a diagnostic test, canimprove during treatment. To qualify for the trial, a subject must be an adult ≥ 18 and ≤65 years of age and meets the WHO-defined post-COVID-19 condition and has one or morenew-onset Long Covid symptom that persist ≥ 6 months after the diagnosis of acuteCOVID-19 infection. A total of 252 participants will take either two daily doses of twoexisting medications (Maraviroc and Atorvastatin together as separate tablets) or aplacebo (pills with no active ingredient) for 16 weeks. Although these medications arenot yet approved for Long Covid, they are FDA-approved for use in treating other healthconditions.
Not Provided
Drug: Maraviroc (MVC)
Maraviroc, 300mg per tablet. Atorvastatin, 10mg per tablet
Drug: Atorvastatin, 10mg, 20mg, 40mg
Atorvastatin, 10mg will be given twice daily oral along with Maraviroc, 300-mg
Drug: Placebo, Maraviroc
Placebo of Maraviroc, 300mg
Drug: Placebo, Atorvastatin
Placebo of Atorvastin, 10mg
Inclusion Criteria:
1. ≥ 18 and ≤ 65 years of age at the time of consent
  2. Meets WHO-defined post-COVID-19 condition (WHO definition: 'Post COVID-19 condition
     occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection,
     usually 3 months from the onset of COVID-19 with symptoms that last for at least 2
     months. Common symptoms include fatigue, shortness of breath, cognitive dysfunction
     but also others and generally have an impact on everyday functioning. Symptoms may
     be new onset following initial recovery from an acute COVID-19 episode or persist
     from the initial illness. Symptoms may also fluctuate or relapse over time).
  3. One or more new onset symptoms that persisted greater than 6 months after the
     diagnosis of acute COVID-19 infection. These symptoms include: cognitive impairment
     (brain fog), migraines, post exertional malaise (PEM), myalgias, arthralgias, severe
     fatigue, tachyarrhythmias, postural orthostatic tachycardia syndrome (POTS), and
     shortness of breath.
  4. Documented confirmation of previous COVID-19 infection from a positive PCR
     laboratory test and/or medical records from healthcare provider that coincides with
     the diagnosis of Long-COVID/PASC.
  5. Lyme screen (Borrelia, Bartonella, Babesia) two-tier serologic negative (centrally
     assessed).
6. Epstein-Barr Virus (EBV) DNA negative (centrally assessed).
7. A long hauler index (LHI) of >0.5
8. FSS score ≥ 36
  9. Female participants should be surgically sterilized or post-menopausal or must agree
     to take effective contraceptive measures during the study period. Adequate methods
     of birth control include: condoms, male or female, with or without a spermicide;
     diaphragm or cervical cap with spermicide; intrauterine device; any of the methods
     that require a prescription (such as contraceptive pills or path) or a male partner
     who has previously undergone vasectomy.
 10. Participant is willing and able to participate in the study and comply with all
     study requirements.
 11. Participant provided signed and dated IRB approved informed consent prior to
     initiation of any study procedures.
Exclusion Criteria:
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. Pre-COVID history of autoimmune conditions, migraines, neuropathy, inflammatory
     bowel disease (IBD), obsessive-compulsive disorder (OCD), chronic fatigue syndrome,
     or fatigue duration for ≥5 year, EBV infection, Lyme disease, fibromyalgia,
     arthritis, chronic obstructive pulmonary disease (COPD), asthma, chronic kidney
     disease, chronic heart failure (CHF), arrhythmias, bleeding disorders, and
     anticoagulation therapy.
  4. Presence of other conditions or differential diagnosis better explaining the
     symptoms of the patient than the suspected long COVID/PASC.
5. Hepatic impairment defined as Childs-Pugh Score B or greater.
  6. Active/acute infectious diseases like tuberculosis, human immunodeficiency virus
     infection (HIV), cytomegalovirus (CMV), Lyme, EBV, hepatitis B virus (HBV),
     hepatitis C virus (HCV).
7. Ongoing immunosuppressive therapy.
8. Use of statins within 6 months of randomization.
  9. Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or
     glecaprevir plus pibrentasvir, or lipid modifying doses (>1 gram/day) of niacin.
10. Severe renal impairment defined as GFR<30.
11. AST:ALT ratio>1.5
12. Elevations in IL-8 (>21 (pg/ml) and or IL-13 (>6.1 pg/ml) (centrally assessed)
 13. Pregnant, breastfeeding, or unwilling to practice birth control during participation
     in the study.
 14. History of illicit drug abuse (including marijuana or alcohol abuse) within 3 months
     of enrollment.
15. Inability to provide consent.
University of Arizona
Tucson	5318313, Arizona	5551752, United States
Investigator: Sairam Parthasarathy, MD
Contact: 520-626-5287
 spartha1@arizona.edu
Investigator: Sairam Parthasarathy, MD
Brad Fox
623-824-9165
bradfoxaz@gmail.com
Dan Casey
609-346-8806
dcasey@incelldx.com
Not Provided