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).

Part of paid clinical trials in Tucson, Arizona.

Sponsor
HealthBio, Inc.
Study ID
NCT06974084
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Maraviroc (MVC) — DRUG
    Maraviroc, 300mg per tablet. Atorvastatin, 10mg per tablet
  • Atorvastatin, 10mg, 20mg, 40mg — DRUG
    Atorvastatin, 10mg will be given twice daily oral along with Maraviroc, 300-mg
  • Placebo, Maraviroc — DRUG
    Placebo of Maraviroc, 300mg
  • Placebo, Atorvastatin — DRUG
    Placebo of Atorvastin, 10mg

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
May 2025
Primary completion
Feb 1, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Placebo Comparator: Placebo of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily

Primary Outcome Measure

Fatigue [ Time Frame: FSS scores will be taken during screening (0-28 days before the first baseline)at visit 3 (week 8 +/-3D) and at the EOT visit, week 16. The PGI-S score will be collected at Visit One, Day 1, Visit 3 (week 8) and EOT (week 16) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85719
Sairam Parthasarathy, MD
[email protected]
520-626-5287
Sairam Parthasarathy, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of Arizona· Tucson, AZ

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