Ampligen for Post-COVID Syndrome
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.12345Why 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-19.36789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive twice weekly IV infusions of Ampligen® or placebo for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo / Normal Saline
- Rintatolimod
Find a Clinic Near You
Who Is Running the Clinical Trial?
AIM ImmunoTech Inc.
Lead Sponsor
Amarex Clinical Research
Collaborator