Investigating Measurable PRO Acuity Trial (IMPACT) is a Multi-Center Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Maraviroc and Atorvastatin to Improve Neurocognitive and Physical Function of Subjects With Long COVID-19/Post-Acute Sequelae of COVID-19 (PASC). (IMPACT-LC)

HealthBio, Inc.

Status and phase: Begins enrollment in 2 months; Phase 3; Phase 2

Conditions: Long COVID

Treatments: Drug: Maraviroc (MVC); Drug: Placebo, Maraviroc; Drug: Atorvastatin, 10mg, 20mg, 40mg; Drug: Placebo, Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06974084

IMPACT Long Covid Treatment

Details and patient eligibility

About

The IMPACT Long Covid Treatment clinical study (IMPACT-LC) is testing two repurposed and previously approved drugs, Maraviroc and Atorvastatin, for the treatment of non-hospitalized subjects with long COVID/Post-Acute Sequelae of COVID (PASC). The main goals of the clinical study are to determine if this combination drug therapy can improve neurocognitive and physical functions in Long Covid patients, such as fatigue severity, heart rate, blood pressure, digestion, breathing, dizziness, and cognitive function. A secondary goal is to determine if biomarker levels, measured by a diagnostic test, can improve 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 more new-onset Long Covid symptom that persist ≥ 6 months after the diagnosis of acute COVID-19 infection. A total of 252 participants will take either two daily doses of two existing medications (Maraviroc and Atorvastatin together as separate tablets) or a placebo (pills with no active ingredient) for 16 weeks. Although these medications are not yet approved for Long Covid, they are FDA-approved for use in treating other health conditions.

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

252 participants in 2 patient groups, including a placebo group

Study Drug; Combination of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily

Active Comparator group

Description:

Subjects randomized to maraviroc/atorvastatin will receive maraviroc 300 mg and atorvastatin 10 mg twice daily oral for 16 weeks.

Treatment:

Drug: Atorvastatin, 10mg, 20mg, 40mg

Drug: Maraviroc (MVC)

Placebo of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily

Placebo Comparator group

Treatment:

Drug: Placebo, Atorvastatin

Drug: Placebo, Maraviroc