Maraviroc + Atorvastatin for Post-COVID Syndrome

(IMPACT-LC Trial)

Overseen By Brad Fox

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: HealthBio, Inc.

Must not be taking: Statins, Cyclosporine, Gemfibrozil, others

Disqualifiers: Autoimmune, Asthma, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two existing medications, Maraviroc and Atorvastatin, to determine if they can alleviate symptoms of long COVID. The goal is to see if these drugs can improve fatigue, dizziness, breathing difficulties, and brain fog. Participants will take either these medications or a placebo (a pill with no active drug) for 16 weeks. Individuals who have experienced long COVID symptoms, such as severe fatigue or brain fog, for more than six months after recovering from COVID-19 might be suitable candidates. As a Phase 2/Phase 3 trial, this study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use statins within 6 months of joining, and certain other medications like cyclosporine and gemfibrozil are not allowed. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Maraviroc and Atorvastatin, already approved for other uses, indicate a strong safety profile. Studies have found Maraviroc safe at the approved dose for treating HIV.

In past studies, participants have generally tolerated these drugs well. For instance, Maraviroc was tested in people with COVID-19 to assess its safety, and it proved safe and tolerable. Atorvastatin, commonly used to lower cholesterol, has a strong safety record.

Although these drugs are not yet approved specifically for Long COVID, their previous approvals and safety data suggest they are likely safe for this new use. Monitoring for any side effects during the trial remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Maraviroc and Atorvastatin for treating Post-COVID Syndrome because it tackles the condition in a unique way. Unlike typical treatments that focus solely on symptom management, this combo targets inflammation and immune response. Maraviroc is known for blocking certain receptors that HIV uses to enter cells, but it's being repurposed here to reduce inflammation. Atorvastatin, commonly used to manage cholesterol, has anti-inflammatory properties that may help improve blood vessel health affected by COVID-19. Together, they offer a novel approach that could address the root causes of Post-COVID Syndrome, potentially speeding up recovery for patients.

What evidence suggests that this trial's treatments could be effective for Long Covid?

This trial will evaluate the combination of Maraviroc and Atorvastatin for Post-COVID Syndrome. Research has shown that Maraviroc and Atorvastatin might ease Long COVID symptoms by reducing inflammation. Maraviroc blocks a specific part of the immune system involved in inflammation. Atorvastatin, typically used to lower cholesterol, also helps reduce inflammation. Early studies suggest these drugs could improve fatigue, heart rate, blood pressure, and cognitive issues in Long COVID patients. Although not yet approved specifically for Long COVID, their ability to reduce inflammation offers hope for effectiveness in treating this condition. Participants in this trial will receive either the combination of Maraviroc and Atorvastatin or a placebo. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults aged 18-65 with long COVID symptoms persisting for 6+ months post-infection can join this trial. They must meet WHO's post-COVID condition criteria but cannot be hospitalized due to COVID. People are excluded if they fall outside the age range, have conditions not defined by WHO as Long Covid, or have other health issues that could interfere with the study.

Inclusion Criteria

Participant willing and able to participate in the study and comply with all study requirements

Lyme screen two-tier serologic negative

I have had COVID-19, confirmed by a PCR test or medical records.

Exclusion Criteria

I am currently on medication to suppress my immune system.

Pre-COVID history of various medical conditions

My symptoms are not caused by long COVID.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0-4 weeks

1 visit (in-person)

Treatment

Participants receive Maraviroc and Atorvastatin or placebo for 16 weeks

16 weeks

Visits at Day 1, Week 4, Week 8, Week 12, and Week 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Atorvastatin
• Maraviroc

Trial Overview The IMPACT-LC study is testing Maraviroc and Atorvastatin—drugs approved for other uses—to see if they improve cognitive and physical functions in non-hospitalized long COVID patients. The trial involves taking these drugs or a placebo daily for 16 weeks to assess improvements in symptoms like fatigue, heart rate, and cognition.

How Is the Trial Designed?

Group I: Study Drug; Combination of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily Active Control 2 Interventions

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

Group II: Placebo of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

HealthBio, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06974084

NCT06974084 | Investigating Measurable PRO Acuity Trial ... To determine the safety profile of maraviroc and atorvastatin in patients treated for Long COVID-19. Participants report data will be compiled as follows:.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9944830/

Case series: Maraviroc and pravastatin as a therapeutic ... Case series: Maraviroc and pravastatin as a therapeutic option to treat long COVID/Post-acute sequelae of COVID (PASC). Bruce K Patterson ...

3. biospace.com biospace.com/press-releases/healthbio-therapeutics-begins-fda-approved-fast-track-clinical-trial-for-treatment-of-long-covid-with-a-patented-combination-of-maraviroc-and-atorvastatin

HealthBio™ Therapeutics Begins FDA-Approved Fast ... The 32-week randomized, 252 patient, double-blind, placebo-controlled, multicenter study will evaluate the safety and efficacy of the drug combination.

4. withpower.com withpower.com/trial/maraviroc-atorvastatin-for-post-covid-syndrome-ad3f0

Maraviroc + Atorvastatin for Post-COVID Syndrome 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 ...

5. pharmafocusamerica.com pharmafocusamerica.com/news/fda-grants-approval-for-healthbioais-clinical-trial-testing-selzentry-maraviroc-and-lipitor-atorvastatin-combination-in-treating-long-covidpasc

FDA Grants Approval for HealthBioAI's Clinical Trial ... The protocol involving maraviroc and atorvastatin aims to mitigate vascular inflammation through the CCR5 pathway, potentially leading to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04435522

Maraviroc in Patients With Moderate and Severe COVID-19 This study seeks to establish whether one week of treatment with Maraviroc, used at its approved dosage for HIV, is safe and tolerable in patients with SARS- ...