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NOT YET RECRUITING
NCT06974084
PHASE2/PHASE3

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).

Sponsor: HealthBio, Inc.

View on ClinicalTrials.gov

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.

Official title: A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID/Post-Acute Sequalae of Covid (PASC)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2025-09-01

Completion Date

2026-04

Last Updated

2025-05-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

Maraviroc (MVC)

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

DRUG

Atorvastatin, 10mg, 20mg, 40mg

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

DRUG

Placebo, Maraviroc

Placebo of Maraviroc, 300mg

DRUG

Placebo, Atorvastatin

Placebo of Atorvastin, 10mg

Locations (1)

University of Arizona

Tucson, Arizona, United States