Post COVID-19 ConditionPhase 2NCT05592418
Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions
A Phase 2 study testing Rintatolimod in people with Post COVID-19 Condition and Long COVID, run by AIM ImmunoTech Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of Ampligen® administered twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition of fatigue. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post COVID-19 Condition, Long COVID
- What is being tested?
- Rintatolimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2023to 30 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adult between 18 to 60 (inclusive) years of age at time of enrollment.
- Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing at least 12 weeks prior to baseline.
- Note: For subjects with COVID-19 symptoms who were not tested for the presence of SARS-CoV-2, a positive serum antibody test for SARS-CoV-2 will be sufficient in subjects not vaccinated for COVID-19 or it can be shown that the positive antibody cannot be associated with the COVID-19 vaccination.
- Laboratory confirmed negative SARS-CoV-2 (COVID-19) infection by a government approved test / kit at time of enrollment.
- Subject meets the criteria of fatigue per the 1994 CDC Case Definition for Chronic Fatigue Syndrome (CFS): Unexplained persistent or relapsing chronic fatigue that is of new or definite onset (i.e., not lifelong), is not the result of ongoing exertion, is not substantially alleviated by rest, and results in substantial reduction in previous levels of occupational, educational, social, or personal activities. The fatigue must have persisted or recurred during 3 or more consecutive months of illness and must not have preceded the onset of the COVID-19 symptoms.
- PROMIS® Fatigue- Short Form 7a score of ≥21 at screening and baseline.
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- Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
- Note: Below are the examples of clinically significant ECG abnormalities:
- Previous documented evidence of myocardial infarction or recent significant change in the resting EKG suggesting infarction or other acute cardiac events.
- Current symptoms of coronary insufficiency (i.e. - angina pectoris and/or ST segment depression on EKG).
- Evidence of uncontrolled atrial or frequent or complex ventricular ectopy, or myocardial conduction defect which would increase the risk of syncope (for example, second degree or higher A-V block).
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Men and women of childbearing potential and their partner must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, bilateral tubal occlusion, or vasectomy) or must practice complete sexual abstinence for the duration of the study (excluding women who are not of childbearing potential and men who have been sterilized).
- Females of child-bearing potential must have a negative urine pregnancy test at Screening Visit and prior to receiving the first dose of study drug; and Male participants must agree to use contraception and refrain from donating sperm for at least 90 days after the last dose of study intervention.
- Subject is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions.
Who cannot join
- Inability to provide informed consent or to return to the Investigator's site for scheduled infusions and evaluations.
- Exhibiting signs of moderate or severe pulmonary disease (such as COPD, asthma, or pulmonary fibrosis).
- Ongoing requirement of oxygen therapy.
- Pulse oxygen saturation (SpO2) of <94% on room air at the time of screening.
- Thrombocytopenia (platelets <100×109/L), anemia (hemoglobin <9.0 g/dL), or leukopenia (WBC <3×109/L) on screening labs
- History of splenectomy.
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- Known hypercoagulable state or at increased risk of thrombosis (e.g., due to immobility)
- Liver cirrhosis or patient showing signs of clinical jaundice at the time of screening.
- Transaminase (ALT or AST) >3X ULN or total bilirubin >2X ULN at screening
- Chronic kidney disease stage 4 or requiring dialysis at the time of screening.
- Estimated GFR <60 mL/min/1.73 m2 at the time of screening
- NYHA Class III or IV congestive heart failure (CHF).
- Exhibiting signs of uncontrolled hypo-or hyper-thyroidism at the time of Screening.
- Diagnosis of autoimmune disease (e.g., SLE, rheumatoid arthritis, psoriasis) at the time of screening
- Uncontrolled rheumatologic disorders at the time of screening.
- Diagnosis of sleep apnea (central or obstructive) at the time of screening.
- History of organ transplantation or are candidates for organ transplantation at the time of screening.
- History of Chronic Fatigue Syndrome prior to COVID-19 infection.
- History of fibromyalgia prior to COVID-19 infection.
- History of major psychiatric disorder including psychotic or melancholic features, bipolar disorders, schizophrenia of any subtype, schizoaffective disorder, major depression delusional disorders of any subtype, dementias of any subtype, anorexia nervosa or bulimia nervosa.
- Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
- Any other clinically significant serious systemic diseases, chronic or intercurrent active medical disorder and other reasons which would interfere with study conduct or study results interpretation per the Investigator.
- Chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe per the investigator.
- Therapy with interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. Subjects must give written informed consent prior to discontinuation of investigational drugs.
- Treatment with any of the following therapies within the eight (8) weeks immediately preceding the start of study baseline or during baseline: systemic glucocorticoids (i.e., hydrocortisone, prednisone, etc.) or mineralocorticoids (i.e., fludrocortisone (Florinef), etc.), interferons, interleukin-2, systemic antivirals, gamma globulin or investigational drugs or experimental agents not yet approved for use in the United States.
- Prior participation in an Ampligen® study.
- Medical necessity, as determined by the patient's primary doctor or the principal investigator, to continue aspirin (ASA) or non-steroidal anti-inflammatory (NSAID) drugs for 20 consecutive days or for more than 10% of the study duration.
- History of congestive heart failure, suspected or known dissecting aneurysm, recent systemic or pulmonary embolus or myocardial infarction (≤ 6 months), severe valvular heart disease, ventricular aneurysm, active or suspected myocarditis or pericarditis, thrombophlebitis or intracardiac thrombi, or acute infection.
- Evidence of moderate or severe obstructive pulmonary disease.
- Resting diastolic blood pressure > 115 mm Hg or resting systolic blood pressure > 200 mm Hg.
- Uncontrolled metabolic disease (e.g., diabetes, thyrotoxicosis, or myxedema).
- Concurrent use of any beta blockers and/or bronchodilators which cannot remain at a stable dosage level during baseline and the study.
- History of alcohol or other substance abuse within two (2) years before the onset of acute COVID-19 or at any time afterward.
- History of suicidal ideation, suicide attempt, or suicidal behavior within two (2) years of baseline. A score of 10 or greater on the PHQ-9 at Baseline indicates symptoms of depression and will exclude subject. A score of greater than zero on question nine (9) of the PHQ-9 at Baseline indicates suicidal ideation and will exclude subject.
- Pregnant or breast feeding.
- Participation in another study for an investigational treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Hope Clinical Research
Canoga Park, California, 91303
Zenos Clinical Research
Dallas, Texas, 75230
Alfa Medical Research
Davie, Florida, 33024
310 Clinical Research
Inglewood, California, 90301
Acclaim Clinical Research
San Diego, California, 92120
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ampligen® in Patients With Post-COVID Conditions
The purpose of this study is to assess the efficacy and safety of Ampligen® administered twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition of fatigue.
Read the detailed description
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the efficacy and safety of Ampligen® in patients experiencing the Post-COVID Condition of fatigue. Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen® or placebo.
- Conditions
- Post COVID-19 Condition, Long COVID
- Being tested
- Rintatolimod, Placebo / Normal Saline
- 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.
RintatolimodDrug
Also called Ampligen, poly I : poly C12U, Rintatolimod (poly I : poly C12U)
100 to 400 mg twice weekly
Placebo / Normal SalineOther
40 to 160 mL twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Ampligen / rintatolimod | Experimental | Subjects will receive rintatolimod (intravenous [IV]), up to 400 mg twice weekly for 12 weeks. Receives: Drug: Rintatolimod |
| Placebo / Saline | Placebo comparator | Subjects will receive placebo / normal saline (intravenous [IV]), up to 160 mL twice weekly for 12 weeks. Receives: Other: Placebo / Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score)
Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue.
Measured: Baseline and Week 13
Secondary outcomes (6)
Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score)
Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue.
Measured: Baseline to Week 6
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven
Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. For this endpoint, the last question of "How often did you have enough energy to exercise strenuously" was excluded. Therefore, the lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 33.4; the highest possible T-score is 76.8. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual.
Measured: Baseline to Week 6 and 13
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT)
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance.
Measured: Baseline to week 6 and week 13
Percentage of Subjects With Minimal Clinically Important Difference (MCID)
Percentage of subjects with increase of at least 54 m from baseline in the Six-Minute Walk Test (6MWT) at the end of 12-week treatment phase presented and summarized descriptively by treatment group.
Measured: End of 12 week treatment phase
Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score).
Change in mean cognitive function T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Cognitive Function - Abilities short form 8a that assesses self-perceived cognitive deficits. The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 23.27; the highest possible T-score is 67.09. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the better the cognitive function of the individual. Scores >45 are within normal limits, 40-45 mild, 30-40 moderate, and <30 severe cognitive dysfunction.
Measured: Baseline to Week 6 and 13
Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score)
Change in mean sleep disturbance T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance - short form 4a that assesses self-perceived sleep quality. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 32; the highest possible T-score is 73.3. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the sleep disturbance of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue.
Measured: Baseline to Week 6 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start30 Jun 2023
- Primary completion17 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post COVID-19 ConditionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIM ImmunoTech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- David R Strayer, MD, Study director, AIM ImmunoTech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592418
- Sponsor's protocol ID
- AMP-518
- Status last verified
- Dec 2024
- First submitted
- 20 Oct 2022
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ampligen® in Patients With Post-COVID Conditions
- ClinicalTrials.gov ID
- NCT05592418
- Acronym / sponsor ID
- AMP-518
- Conditions
- Post COVID-19 Condition, Long COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AIM ImmunoTech Inc.Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of Ampligen® administered twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition of fatigue.
Detailed description
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the efficacy and safety of Ampligen® in patients experiencing the Post-COVID Condition of fatigue. Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen® or placebo.
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 |
|---|---|---|
| Ampligen / rintatolimod | Experimental | Drug: RintatolimodSubjects will receive rintatolimod (intravenous [IV]), up to 400 mg twice weekly for 12 weeks. |
| Placebo / Saline | Placebo comparator | Other: Placebo / Normal SalineSubjects will receive placebo / normal saline (intravenous [IV]), up to 160 mL twice weekly for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or female adult between 18 to 60 (inclusive) years of age at time of enrollment.
- Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing at least 12 weeks prior to baseline.
- Note: For subjects with COVID-19 symptoms who were not tested for the presence of SARS-CoV-2, a positive serum antibody test for SARS-CoV-2 will be sufficient in subjects not vaccinated for COVID-19 or it can be shown that the positive antibody cannot be associated with the COVID-19 vaccination.
- Laboratory confirmed negative SARS-CoV-2 (COVID-19) infection by a government approved test / kit at time of enrollment.
- Subject meets the criteria of fatigue per the 1994 CDC Case Definition for Chronic Fatigue Syndrome (CFS): Unexplained persistent or relapsing chronic fatigue that is of new or definite onset (i.e., not lifelong), is not the result of ongoing exertion, is not substantially alleviated by rest, and results in substantial reduction in previous levels of occupational, educational, social, or personal activities. The fatigue must have persisted or recurred during 3 or more consecutive months of illness and must not have preceded the onset of the COVID-19 symptoms.
Key exclusion criteria (36 listed)
- Inability to provide informed consent or to return to the Investigator's site for scheduled infusions and evaluations.
- Exhibiting signs of moderate or severe pulmonary disease (such as COPD, asthma, or pulmonary fibrosis).
- Ongoing requirement of oxygen therapy.
- Pulse oxygen saturation (SpO2) of <94% on room air at the time of screening.
- Thrombocytopenia (platelets <100×109/L), anemia (hemoglobin <9.0 g/dL), or leukopenia (WBC <3×109/L) on screening labs
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 |
|---|---|---|
| RintatolimodAlso: Ampligen, poly I : poly C12U, Rintatolimod (poly I : poly C12U)100 to 400 mg twice weekly | Drug | Ampligen / rintatolimod |
| Placebo / Normal Saline40 to 160 mL twice weekly | Other | Placebo / Saline |
Primary outcome
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score)
Time frame: Baseline and Week 13
Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue.
6 secondary outcomes
Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score)
Time frame: Baseline to Week 6
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven
Time frame: Baseline to Week 6 and 13
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT)
Time frame: Baseline to week 6 and week 13
Percentage of Subjects With Minimal Clinically Important Difference (MCID)
Time frame: End of 12 week treatment phase
Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score).
Time frame: Baseline to Week 6 and 13
Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score)
Time frame: Baseline to Week 6 and 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Post COVID-19 Condition
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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
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
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. This study is not recruiting at the moment.
David R Strayer, MD study director
AIM ImmunoTech Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rintatolimod in people with Post COVID-19 Condition and Long COVID, run by AIM ImmunoTech Inc. at 5 sites 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 15 inclusion and 36 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score) (time frame: Baseline and Week 13). 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 22 Jan 2025.