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.
≥ 18 and ≤ 65 years of age at the time of consent
Meets WHO-defined post-COVID-19 condition (WHO definition: 'Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months. Common symptoms include fatigue, shortness of breath, cognitive dysfunction but also others and generally have an impact on everyday functioning. Symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms may also fluctuate or relapse over time).
One or more new onset symptoms that persisted for greater than 6 months after the diagnosis of acute COVID-19 infection. These symptoms include: cognitive impairment (brain fog), migraines, post-exertional malaise (PEM), myalgias, arthralgias, severe fatigue, tachyarrhythmias, postural orthostatic tachycardia syndrome (POTS), and shortness of breath. The previous COVID-19 infection should be documented in the form of a positive PCR laboratory test and/or medical records from a healthcare provider. The Long-COVID diagnosis should be documented in the medical records by a healthcare provider.
Negative Lyme screen, as measured by the AcuDart test.
Participation in another therapeutic clinical trial in the past 2 months.
History of allergy or anaphylaxis or allergic reaction to any component of atorvastatin and/or maraviroc.
Uncontrolled hypothyroidism as defined as thyroid-stimulating hormone (TSH) and/or free thyroxine (FT4) values outside the local laboratory reference range at screening, or a change in thyroid hormone replacement dose within 6 weeks prior to screening.
Pre-COVID history of autoimmune conditions, migraines, neuropathy, inflammatory bowel disease (IBD), obsessive-compulsive disorder (OCD), or fatigue duration for ≥5 years, EBV infection, Lyme disease, fibromyalgia, arthritis, chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD G3a or greater), chronic heart failure (CHF), arrhythmias, bleeding disorders, and anticoagulation therapy.
Parallel
Maraviroc (MVC)
DrugMaraviroc, 300mg per tablet. Atorvastatin, 10mg per tablet
Atorvastatin, 10mg, 20mg, 40mg
DrugAtorvastatin, 10mg will be given twice daily oral along with Maraviroc, 300-mg
Placebo, Maraviroc
DrugPlacebo of Maraviroc, 300mg
Placebo, Atorvastatin
DrugPlacebo of Atorvastin, 10mg
Fatigue
Fatigue will be measured via PROMIS Fatigue v1.0. The PROMIS Fatigue 10a assesses fatigue severity in the previous week. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The instrument translates the total raw score into a T-score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population (SD=10).
Improvement in dysautonomia symptoms as reflected by the Composite Autonomic Symptom Score (COMPASS-31)
To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on dysautonomia symptoms 12 weeks after treatment initiation in individuals with Long COVID.
Improved Cognitive Function, measured by the PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a
The PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a is a 6-item sub-set scale of the PROMIS Cognitive Function item bank that assesses patient-perceived cognitive deficits. Each item has five response options ranging in value from one to five. The total raw score for a short form with all questions answered, is the sum of the values of the response to each question and ranges between 6 and 30. The raw score is translated in a T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10.
To assess if maraviroc and atorvastatin decrease the Long Hauler Index (LHI) from baseline to week 12.
To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on the LHI 12 weeks after treatment initiation in individuals with Long COVID.
To assess the proportion of participants with a PROMIS Fatigue T-score improvement from baseline ≥5 points 12 weeks after treatment initiation.
In subjects with Long COVID complying with the key protocol criteria (evaluable participants) who received 12 weeks of study treatment: ● Change in the proportion of subjects who improve their PROMIS T-score from baseline to week 12 in maraviroc/atorvastatin and placebo groups.
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HealthBio, Inc.
Lead sponsor
Lindus Health, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
