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).

NCT ID: NCT06974084

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Maraviroc (MVC)

Intervention Type: DRUG

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

Atorvastatin, 10mg, 20mg, 40mg

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo, Maraviroc

Intervention Type: DRUG

Placebo of Maraviroc, 300mg

Placebo, Atorvastatin

Intervention Type: DRUG

Placebo of Atorvastin, 10mg

Interventions

Maraviroc (MVC)

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

Intervention Type: DRUG

Atorvastatin, 10mg, 20mg, 40mg

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

Intervention Type: DRUG

Placebo, Maraviroc

Placebo of Maraviroc, 300mg

Intervention Type: DRUG

Placebo, Atorvastatin

Placebo of Atorvastin, 10mg

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthBio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Central Contacts

Brad Fox

Role: CONTACT

bradfoxaz@gmail.com

623-824-9165

Dan Casey

Role: CONTACT

dcasey@incelldx.com

609-346-8806

Facility Contacts

Sairam Parthasarathy, MD

Role: primary

spartha1@arizona.edu

520-626-5287

Other Identifiers

IMPACT Long Covid Treatment

Identifier Type: -

Identifier Source: org_study_id