Ampligen for Post-COVID Syndrome

No longer recruiting at 4 trial locations

Overseen By Diane Young

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: AIM ImmunoTech Inc.

Must not be taking: Interferons, Glucocorticoids, NSAIDs, others

Disqualifiers: Pulmonary disease, Autoimmune, Psychiatric, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of a treatment called Ampligen (rintatolimod) for individuals experiencing fatigue after recovering from COVID-19. Participants will receive either Ampligen or a placebo through IV infusions twice a week for 12 weeks. The trial seeks individuals who have experienced persistent fatigue since having COVID-19, which affects daily activities and isn't relieved by rest. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you cannot use certain treatments like systemic glucocorticoids, interferons, or investigational drugs within eight weeks before starting the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rintatolimod, also known as Ampligen, has been safely tested in people before. Studies have found it to be well-tolerated by individuals with conditions like chronic fatigue syndrome. For example, ongoing research under the AMP-511 protocol provides current safety data, indicating that patients continue to use it without major problems.

Additionally, other studies have tested Ampligen in different forms. One study on its use as a nasal spray in healthy people showed positive safety results, suggesting that the treatment is generally safe when administered in various ways.

Although this trial uses intravenous (IV) administration, the positive safety data from other forms of use support its safety profile. While monitoring for side effects remains important, this background information suggests that Ampligen could be a safe option for those seeking treatment for post-COVID fatigue. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for post-COVID conditions, which primarily focus on symptom relief and supportive care, rintatolimod offers a unique approach by targeting the immune system. This drug acts as an immune modulator, potentially enhancing the body's antiviral defenses. Researchers are excited because it could offer a new mechanism of action that directly influences immune response, setting it apart from existing treatments. Additionally, rintatolimod is administered intravenously, which may allow for more controlled dosing and potentially quicker effects compared to oral medications.

What evidence suggests that Ampligen might be an effective treatment for Post-COVID fatigue?

Research shows that rintatolimod, also known as Ampligen, may help reduce fatigue in people with post-COVID conditions. Earlier studies demonstrated that rintatolimod significantly improved symptoms of chronic fatigue, providing noticeable relief to patients. Additionally, published clinical results highlight Ampligen's benefits for post-COVID fatigue. In this trial, participants will receive either rintatolimod or a placebo to further evaluate its effectiveness for those dealing with fatigue after COVID-19. ^{3 6 7 8 9}

Who Is on the Research Team?

David R Strayer, MD

Principal Investigator

AIM ImmunoTech Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Note: Below are the examples of clinically significant ECG abnormalities:

Subject is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions

Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing at least 12 weeks prior to baseline

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive twice weekly IV infusions of Ampligen® or placebo for 12 weeks

12 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo / Normal Saline
• Rintatolimod

How Is the Trial Designed?

Group I: Ampligen / rintatolimod Experimental Treatment 1 Intervention

Subjects will receive rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks.

Group II: Placebo / Saline Placebo Group 1 Intervention

Subjects will receive placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks.

Who Is Running the Clinical Trial?

AIM ImmunoTech Inc.

Lead Sponsor

Trials

15

Recruited

710+

Amarex Clinical Research

Collaborator

Trials

28

Recruited

1,700+

Citations

1.

aimimmuno.com

aimimmuno.com/aim-immunotech-reports-positive-mid-year-safety-and-efficacy-data-from-phase-2-study-evaluating-ampligen-rintatolimod-in-combination-with-astrazenecas-imfinzi-durvalumab-for-the-trea/

Mid-year report of combination therapy ...

AIM ImmunoTech Reports Positive Mid-year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05592418

Study to Evaluate the Efficacy and Safety of Ampligen in ...

This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the efficacy and safety of Ampligen® in patients ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4917909/

Efficacy of rintatolimod in the treatment of chronic fatigue ...

Rintatolimod has achieved statistically significant improvements in primary endpoints in Phase II and Phase III double-blind, randomized, placebo-controlled ...

4.

targetedonc.com

targetedonc.com/view/rintatolimod-plus-durvalumab-shows-encouraging-early-outcomes-in-metastatic-pancreatic-cancer

Rintatolimod Plus Durvalumab Shows Encouraging Early ...

Early data from the DURIPANC study shows promising safety and survival benefits of rintatolimod and durvalumab for metastatic pancreatic ...

5.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/ampligen-clinical-trial-results-published-for-post-covid-conditions/

Ampligen Clinical Trial Results Published for Post-COVID ...

AIM ImmunoTech Inc. announced final clinical study results (AMP-518) for Ampligen in treating post-COVID conditions, specifically fatigue.

6.

aimimmuno.com

aimimmuno.com/aim-immunotech-reports-positive-safety-tolerability-and-biological-activity-data-for-intranasal-ampligen-rintatolimod-in-healthy-subjects/

Intranasal administration of Ampligen ...

The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® ( ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05592418

NCT05592418 | Study to Evaluate the Efficacy and Safety ...

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 ...

8.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0031334

PLOS One - Research journals

The objective of the study was to examine the efficacy and safety of a TLR-3 agonist, rintatolimod (Poly I: C12U), in patients with debilitating CFS/ME. Methods ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00215800

The Study of the Safety and Efficacy of Ampligen in Chronic ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome.