Official Title
A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID/Post-Acute Sequalae of Covid (PASC)
Brief Summary

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.

Detailed Description

Not Provided

Not yet recruiting
Long Covid

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
United States
Locations

University of Arizona
Tucson, Arizona, United States

Investigator: Sairam Parthasarathy, MD
Contact: 520-626-5287
spartha1@arizona.edu

Investigator: Sairam Parthasarathy, MD

Contacts

Brad Fox
623-824-9165
bradfoxaz@gmail.com

Dan Casey
609-346-8806
dcasey@incelldx.com

Not Provided

HealthBio, Inc.
NCT Number
Keywords
long COVID
Post-COVID Syndrome (PCS)
MeSH Terms
Post-Acute COVID-19 Syndrome
Maraviroc
Atorvastatin