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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-05-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • HealthBio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-02-01
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06974084 on ClinicalTrials.gov