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
United States252 participantsStarted 2026-07-15
Plain-language summary
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. 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 ≥ 3 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 18 and ≤ 65 years of age at the time of consent
. 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).
. One or more new onset symptoms that persisted for 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. The previous COVID-19 infection should be documented in the form of a positive PCR laboratory test and/or medical records from a healthcare provider. The Long-COVID diagnosis should be documented in the medical records by a healthcare provider.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a combination of maraviroc — an HIV antiviral — and atorvastatin — a cholesterol drug — for Long COVID fatigue, which is a pretty unusual pairing; can you explain why these two drugs are being tested together and what the current evidence says about whether they might actually help?
2Since this trial is Phase 2/3 and hasn't started recruiting yet, does that mean there's still limited safety data on using maraviroc and atorvastatin together specifically for Long COVID patients, and what risks should I be aware of before considering it?
3The trial is measuring fatigue as its main outcome — if my most disabling Long COVID symptoms are things like brain fog, shortness of breath, or post-exertional malaise rather than fatigue, is this trial likely to be relevant for my situation, or would something else be a better fit?
4Given that this trial hasn't started recruiting yet, do you think waiting for it to open makes sense for my situation, or are there existing treatments or other trials already enrolling that I should be considering in the meantime?
5Since this is a placebo-controlled trial where I'd have a chance of receiving a placebo rather than the actual drugs, how would that affect my care — would I still have access to whatever standard treatments are currently available for Long COVID while I'm participating?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue
Timeframe: PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12.
. Negative Lyme screen, as measured by the AcuDart test.
. Epstein-Barr Virus (EBV) DNA negative (centrally assessed).
. A long hauler index (LHI) of \>0.71
. A PROMIS Fatigue 10a T-score score \> 55
. Participants of childbearing potential 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.
Exclusion criteria
. Participation in another therapeutic clinical trial in the past 2 months.
. History of allergy or anaphylaxis or allergic reaction to any component of atorvastatin and/or maraviroc.
. 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.
. 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.
. 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.
. Hepatic impairment, defined as Child-Pugh Score 7-9 (Class B) or greater.
. 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).
. Ongoing immunosuppressive therapy, such as cyclosporine A (CsA).