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

NCT06974084 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IMPACT Long Covid Treatment
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID

Keywords

Long Covid; Post-COVID syndrome (PCS)

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Fatigue will be measured via PROMIS Fatigue v1.0. The PROMIS Fatigue 10a assesses fatigue severity in the previous week. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The instrument translates the total raw score into a T-score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population (SD=10).

  PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12.

Secondary Outcomes (6)

• Improvement in dysautonomia symptoms as reflected by the Composite Autonomic Symptom Score (COMPASS-31)

  Scores will be determined at Visit 1 (Day 1) and EOT (week -12)

• Improved Cognitive Function, measured by the PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a

  Difference in T-score measured at Visit 1 (Day 1) and EOT (week-12)

• To assess if maraviroc and atorvastatin decrease the Long Hauler Index (LHI) from baseline to week 12.

  LHI will be measured at Screening and EOT (week-12)

• To assess the proportion of participants with a PROMIS Fatigue T-score improvement from baseline ≥5 points 12 weeks after treatment initiation.

  From baseline Visit 1 (Day-1) and EOT (week-12)

• To determine the safety profile of maraviroc and atorvastatin in patients treated for Long COVID-19

  Adverse event collection will be done during every Visit (Day-1, Week-4, Week-8, Week-12, Week-16 (EOT) and EOS (28-42 Days after last dose)

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

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

PLACEBO COMPARATOR

Drug: Placebo, Maraviroc; Drug: Placebo, Atorvastatin

Interventions

Maraviroc (MVC) DRUG

Maraviroc, 300mg per tablet. Atorvastatin, 10mg per tablet

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

Atorvastatin, 10mg, 20mg, 40mg DRUG

Atorvastatin, 10mg will be given twice daily oral along with Maraviroc, 300-mg

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

Placebo, Maraviroc DRUG

Placebo of Maraviroc, 300mg

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

Placebo, Atorvastatin DRUG

Placebo of Atorvastin, 10mg

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.
• 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.
• Participant is willing and able to participate in the study and comply with all study requirements.
• Participant provided signed and dated IRB approved informed consent prior to initiation of any study procedures.
• Participant is able to read and understand English.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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).
• Use of statins within 6 months of randomization.
• Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir, or lipid-modifying doses (\>1 gram/day) of niacin.
• AST:ALT ratio\>1.5
• Elevations in IL-8 (\>21 (pg/ml) and or IL-13 (\>6.1 pg/ml) (centrally assessed with IncellKINE panel).
• Pregnant or breastfeeding
• 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:

Sponsors & Collaborators

• HealthBio, Inc.: lead
• Lindus Health, Inc.: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Maraviroc; Atorvastatin

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Brad Fox

CONTACT

623-824-9165; bradfoxaz@gmail.com

Brian Brothen

CONTACT

407-415-5891; brianb@incelldx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

US (1)