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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) (IMPACT-LC)
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.
Details
| Lead sponsor | HealthBio, Inc. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 252 |
| Start date | 2025-09-01 |
| Completion | 2026-04 |
Conditions
- Long COVID
Interventions
- Maraviroc (MVC)
- Atorvastatin, 10mg, 20mg, 40mg
- Placebo, Maraviroc
- Placebo, Atorvastatin
Primary outcomes
- Fatigue — 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)
Two Patient Reported Outcomes for fatigue will be measured: 1)Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each of the nine item about fatigue from the FSS is scored on a Likert scale on which 7 is Strongly Agree and 1 is Strongly Disagree. The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity. A total score of \<36 indicates a subject is not suffering from fatigue. 2)Subjects will be asked to complete the single-item PGI-S (Patient Global Impression of Severity). PGI-S is a single item scale for assessing fatigue severity containing 6 response options from 0 (not present) to 5 (very severe). A one-point change in PGI-S from baseline would represent a minimal individual change that is meaningful.
Countries
United States