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

252 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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