Long COVIDPhase 2/3IMPACT-LCNCT06974084
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
A Phase 2/3 study testing Maraviroc (MVC) and Atorvastatin, 10mg, 20mg, 40mg in people with Long COVID, run by HealthBio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Maraviroc (MVC) and Atorvastatin, 10mg, 20mg, 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to May 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
- Epstein-Barr Virus (EBV) DNA negative (centrally assessed).
- A long hauler index (LHI) of >0.71
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- A PROMIS Fatigue 10a T-score score > 55
- Participants of childbearing potential should be surgically sterilized or post-menopausal or must agree to take effective contraceptive measures during the study period. Adequate methods of birth control include: condoms, male or female, with or without a spermicide; diaphragm or cervical cap with spermicide; intrauterine device; any of the methods that require a prescription (such as contraceptive pills or path) or a male partner who has previously undergone vasectomy.
- Participant is willing and able to participate in the study and comply with all study requirements.
- Participant provided signed and dated IRB approved informed consent prior to initiation of any study procedures.
- Participant is able to read and understand English.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
- Presence of other conditions or differential diagnosis that better explains the symptoms of the patient than the suspected long COVID, in the opinion of the investigator.
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- Hepatic impairment, defined as Child-Pugh Score 7-9 (Class B) or greater.
- Active/acute infectious diseases like tuberculosis, human immunodeficiency virus infection (HIV), cytomegalovirus (CMV), (vector based) Lyme, EBV, hepatitis B virus (HBV), hepatitis C virus (HCV).
- Ongoing immunosuppressive therapy, such as cyclosporine A (CsA).
- Use of statins within 6 months of randomization.
- Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir, or lipid-modifying doses (>1 gram/day) of niacin.
- AST:ALT ratio>1.5
- Elevations in IL-8 (>21 (pg/ml) and or IL-13 (>6.1 pg/ml) (centrally assessed with IncellKINE panel).
- Pregnant or breastfeeding
- History of substance use disorder (including alcohol use disorder or cannabis use disorder per DSM-5 criteria) within 3 months of enrollment, OR current hazardous alcohol use as defined by:
- Self-reported consumption >14 drinks/week (males) or >7 drinks/week (females), OR
- Binge drinking (≥5 drinks on one occasion for males, ≥4 for females) ≥1 time per week, OR
- Clinical judgment that alcohol use would interfere with study compliance or safety
- Subjects with risk factors for myocardial ischemia/infarction, including but not limited to those with a prior history of MI, stroke, unstable angina,
- Any significant disease or disorder, which, in the opinion of the Investigator, may either put the participants at risk
- Azole antifungals (ketoconazole or itraconazole are not allowed) or macrolide antibiotics (clarithromycin is not allowed)
- History of use of maraviroc and/or atorvastatin for the off-label treatment of Long COVID.
- Prohibited concomitant medications
- Any statins within 6 months of randomization and between randomization and the participant's scheduled final visit
- Other systemically administered drugs with significant immunosuppressive activity, such as azathioprine, tacrolimus, cyclosporine, methotrexate, or cytotoxic chemotherapy between randomization and the participant's scheduled final visit
- Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:
- clarithromycin
- cobicistat
- elvitegravir/ritonavir
- itraconazole
- ketoconazole
- nefazodone
- protease inhibitors (except tipranavir/ritonavir)
- telithromycin
- Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis:
- cyclosporine or gemfibrozil
- tipranavir plus ritonavir or glecaprevir plus pibrentasvir
- niacin (≥1 gram/day niacin)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Arizona
Tucson, Arizona, 85719
Sairam Parthasarathy, MD, 520-626-5287, spartha1@arizona.edu
Sairam Parthasarathy, MD
About this study
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.
- Conditions
- Long COVID
- Being tested
- Maraviroc (MVC), Atorvastatin, 10mg, 20mg, 40mg, Placebo, Maraviroc, Placebo, Atorvastatin
- Keywords
- Long Covid, Post-COVID syndrome (PCS)
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maraviroc (MVC)Drug
Maraviroc, 300mg per tablet. Atorvastatin, 10mg per tablet
Atorvastatin, 10mg, 20mg, 40mgDrug
Atorvastatin, 10mg will be given twice daily oral along with Maraviroc, 300-mg
Placebo, MaravirocDrug
Placebo of Maraviroc, 300mg
Placebo, AtorvastatinDrug
Placebo of Atorvastin, 10mg
| Study group | Role | What they receive |
|---|---|---|
| Study Drug; Combination of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily | Active comparator | Subjects randomized to maraviroc/atorvastatin will receive maraviroc 300 mg and atorvastatin 10 mg twice daily oral for 16 weeks. Receives: Drug: Maraviroc (MVC); Drug: Atorvastatin, 10mg, 20mg, 40mg |
| Placebo of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily | Placebo comparator | Not described Receives: Drug: Placebo, Maraviroc; Drug: Placebo, Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening and EOT (week-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start15 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974084
- Sponsor's protocol ID
- IMPACT Long Covid Treatment
- Acronym
- IMPACT-LC
- Status last verified
- Jun 2026
- First submitted
- 7 May 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06974084
- Acronym / sponsor ID
- IMPACT-LC / IMPACT Long Covid Treatment
- Conditions
- Long COVID
- Keywords
- Long Covid, Post-COVID syndrome (PCS)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- HealthBio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health, Inc.
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug; Combination of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily | Active comparator | Drug: Maraviroc (MVC), Drug: Atorvastatin, 10mg, 20mg, 40mgSubjects randomized to maraviroc/atorvastatin will receive maraviroc 300 mg and atorvastatin 10 mg twice daily oral for 16 weeks. |
| Placebo of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily | Placebo comparator | Drug: Placebo, Maraviroc, Drug: Placebo, Atorvastatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 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.
- Epstein-Barr Virus (EBV) DNA negative (centrally assessed).
Key exclusion criteria (38 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maraviroc (MVC)Maraviroc, 300mg per tablet. Atorvastatin, 10mg per tablet | Drug | Study Drug; Combination of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily |
| Atorvastatin, 10mg, 20mg, 40mgAtorvastatin, 10mg will be given twice daily oral along with Maraviroc, 300-mg | Drug | Study Drug; Combination of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily |
| Placebo, MaravirocPlacebo of Maraviroc, 300mg | Drug | Placebo of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily |
| Placebo, AtorvastatinPlacebo of Atorvastin, 10mg | Drug | Placebo of Maraviroc (300mg) and Atorvastatin (10mg) given twice daily |
Primary outcome
Fatigue
Time frame: PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12.
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).
6 secondary outcomes
Improvement in dysautonomia symptoms as reflected by the Composite Autonomic Symptom Score (COMPASS-31)
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
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.
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.
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
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
Time frame: Screening and EOT (week-12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
Long COVID
Active, not recruitingObservational study
Pain in Long COVID-19: The Role of Sleep
Long COVID
Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Long COVID, Post COVID-19 Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Maraviroc (MVC) and Atorvastatin, 10mg, 20mg, 40mg in people with Long COVID, run by HealthBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brad Fox (623-824-9165, bradfoxaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.