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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
252
Maraviroc, 300mg per tablet. Atorvastatin, 10mg per tablet
Atorvastatin, 10mg will be given twice daily oral along with Maraviroc, 300-mg
Placebo of Maraviroc, 300mg
Placebo of Atorvastin, 10mg
University of Arizona
Tucson, Arizona, United States
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).
Time frame: PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12.
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.
Time frame: Scores will be determined at Visit 1 (Day 1) and EOT (week -12)
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.
Time frame: Difference in T-score measured at Visit 1 (Day 1) and EOT (week-12)
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.
Time frame: LHI will be measured at Screening and EOT (week-12)
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.
Time frame: From baseline Visit 1 (Day-1) and EOT (week-12)
To determine the safety profile of maraviroc and atorvastatin in patients treated for Long COVID-19
Participants report data will be compiled as follows: Percentage of participants reporting AEs from Dose 1 to 28 days after the last dose. Percentage of participants reporting SAEs from Dose 1 to 28 days after the last dose. Percentage of participants reporting AEs leading to discontinuation. Percentage of participants reporting SAEs leading to discontinuation.
Time frame: Adverse event collection will be done during every Visit (Day-1, Week-4, Week-8, Week-12, Week-16 (EOT) and EOS (28-42 Days after last dose)
To evaluate IncellKINE Biomarkers
To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on IncellKINE biomarker levels in individuals with Long COVID 12 weeks after treatment initiation.
Time frame: Screening and EOT (week-12)
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