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).

NCT06974084 | Not Yet Recruiting Phase 2 DMC 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/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.

Conditions

Long COVID

Keywords

Long Covid; Post-COVID syndrome (PCS)

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Two Patient Reported Outcomes for fatigue will be measured: 1)Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each of the nine item about fatigue from the FSS is scored on a Likert scale on which 7 is Strongly Agree and 1 is Strongly Disagree. The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity. A total score of \<36 indicates a subject is not suffering from fatigue. 2)Subjects will be asked to complete the single-item PGI-S (Patient Global Impression of Severity). PGI-S is a single item scale for assessing fatigue severity containing 6 response options from 0 (not present) to 5 (very severe). A one-point change in PGI-S from baseline would represent a minimal individual change that is meaningful.

  FSS scores will be taken during screening (0-28 days before the first baseline)at visit 3 (week 8 +/-3D) and at the EOT visit, week 16. The PGI-S score will be collected at Visit One, Day 1, Visit 3 (week 8) and EOT (week 16)

Secondary Outcomes (7)

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

  Scores will be determined at Visit 1 (Day 1), Visit 3 (week-8) and EOT (week -16)

• Improvement in Dyspnea

  MRC (Medical Research Council) Dyspnea Scale will be measured at Visit 1 (Day-1), Visit 3 (week-8) and EOT (week-16)

• 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), Visit 3 (week-8) and EOT (week-16)

• To assess if maraviroc and atorvastatin decrease the Long Hauler Index (LHI) from baseline to week 8 and from baseline to week 16.

  LHI will be measured at Visit 1 (Day-1), Visit 3 (week-8) and EOT (week-16)

• To assess the effect of maraviroc and atorvastatin on IncellKINE biomarker levels

  IncellKINE test will be run at Visit 1 (Day-1), Visit 3 (week-8) and EOT (week-16)

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 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.
• 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.
• Lyme screen (Borrelia, Bartonella, Babesia) two-tier serologic negative (centrally assessed).
• Epstein-Barr Virus (EBV) DNA negative (centrally assessed).
• A long hauler index (LHI) of \>0.5
• FSS score ≥ 36
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Presence of other conditions or differential diagnosis better explaining the symptoms of the patient than the suspected long COVID/PASC.
• Hepatic impairment defined as Childs-Pugh Score B or greater.
• Active/acute infectious diseases like tuberculosis, human immunodeficiency virus infection (HIV), cytomegalovirus (CMV), Lyme, EBV, hepatitis B virus (HBV), hepatitis C virus (HCV).
• Ongoing immunosuppressive therapy.
• 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.
• Severe renal impairment defined as GFR\<30.
• AST:ALT ratio\>1.5
• Elevations in IL-8 (\>21 (pg/ml) and or IL-13 (\>6.1 pg/ml) (centrally assessed)
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• History of illicit drug abuse (including marijuana or alcohol abuse) within 3 months of enrollment.
• Inability to provide consent.

Sponsors & Collaborators

• HealthBio, Inc.: lead

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

Dan Casey

CONTACT

609-346-8806; dcasey@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: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)