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)

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.

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

No

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

Location