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.
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
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.
Time frame: 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)
Improvement in dysautonomia symptoms as reflected by the Composite Autonomic Symptom Score (COMPASS-31)
Difference in the mean Composite Autonomic Symptom Score (COMPASS-31) score at week 8 and week 16 between maraviroc/atorvastatin and placebo.
Time frame: Scores will be determined at Visit 1 (Day 1), Visit 3 (week-8) and EOT (week -16)
Improvement in Dyspnea
Difference in mean Medical Research Council (MRC) Dyspnea grade at week 8 and week 16 between maraviroc/atorvastatin and placebo.
Time frame: MRC (Medical Research Council) Dyspnea Scale will be measured at Visit 1 (Day-1), Visit 3 (week-8) and EOT (week-16)
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), Visit 3 (week-8) and EOT (week-16)
To assess if maraviroc and atorvastatin decrease the Long Hauler Index (LHI) from baseline to week 8 and from baseline to week 16.
The LHI was developed using machine learning, and built on a tailored panel of cytokines and chemokines specific for abnormalities in cytokine storm conditions and in chronic COVID-19 patients. It generates a severity score spanning the spectrum of disease severity from mild to critical.
Time frame: LHI will be measured at Visit 1 (Day-1), Visit 3 (week-8) and EOT (week-16)
To assess the effect of maraviroc and atorvastatin on IncellKINE biomarker levels
Change in mean biomarker levels as measured by the IncellKINE assay from baseline to week 8 and from baseline to week 16.
Time frame: IncellKINE test will be run at Visit 1 (Day-1), Visit 3 (week-8) and EOT (week-16)
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 the PK (pharmacokinetic) profiles of atorvastatin and maraviroc in participants treated for Long COVID-19
Blood samples will be collected from participants receiving 4 weeks of study intervention - samples collected at Visit 1 and 2 - with PK profiles run. The PK profiles of atorvastatin and maraviroc will also be measured for all reporting SAE's.
Time frame: PK reports will be generated from patient samples at Visit 1(Day-1) and Visit 2 (week-4). At any reported SAE, PK profile will also be run.
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