drugset / Trial / NCT06974084

A Multi-Center, Individually-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Superiority Trial to Evaluate the Efficacy of the Combination of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID

NCT06974084

Phase 2/3 Not yet recruiting 252 enrolled HealthBio, Inc. Lindus Health, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

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. 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 ≥ 3 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.

Timeline

Start
2026-07-15
Primary completion
2026-12-01
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 10 mg Oral
Comparator Atorvastatin Small molecule 20 mg Oral
Comparator Atorvastatin Small molecule 40 mg Oral
Comparator Maraviroc Other / unclassified 300 mg Oral

Indications