Anktiva for Post-COVID Syndrome

(INTERRUPT_LC Trial)

Overseen By Kamin Personett

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ImmunityBio, Inc.

Must not be taking: Antivirals, Monoclonal antibodies

Disqualifiers: Autoimmune disease, Cardiovascular disease, Stroke, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of Anktiva (N-803), a treatment for individuals experiencing Long COVID symptoms. Participants will receive up to two doses of Anktiva and undergo follow-up exams and tests. The trial seeks individuals who have previously tested positive for COVID-19 and are experiencing at least two new or worsened symptoms, such as fatigue, brain fog, or shortness of breath, for over 60 days. Those with a confirmed COVID infection whose daily life is affected by ongoing symptoms may be a good fit for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.

Is there any evidence suggesting that Anktiva is likely to be safe for humans?

Research has shown that Anktiva, also known as N-803, is being studied for its safety in people with Long Covid. Although detailed information is limited, Anktiva is currently in a phase 2 trial. This phase typically assesses how well people tolerate the treatment after its initial safety has been evaluated in earlier studies.

Anktiva has also been studied for other health issues, providing insights into its safety profile. Past research found that Anktiva was generally well-tolerated, with mostly mild to moderate side effects. Common side effects include injection site reactions and flu-like symptoms, typical of treatments that interact with the immune system.

While researchers are still learning about Anktiva's safety for Long Covid patients, earlier research suggests it is generally manageable with careful monitoring. Prospective trial participants should discuss any concerns with the study team to make an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for post-COVID syndrome, which mainly focus on managing symptoms, N-803 (Anktiva) is designed to enhance the body's immune response. Researchers are excited about this treatment because it uses a unique mechanism, activating specific immune cells called natural killer (NK) cells and T cells, which might help the body recover more effectively from the lingering effects of COVID-19. This approach could offer a new way to address the underlying issues of post-COVID syndrome, rather than just alleviating the symptoms.

What evidence suggests that Anktiva might be an effective treatment for Long Covid?

Research shows that Anktiva (N-803) might help with Long COVID by strengthening the immune system. It improves immune cell function, potentially aiding the body in combating lingering effects of the virus. Earlier studies have examined its ability to increase lymphocyte counts, a type of white blood cell crucial for defense. Although the exact effects on Long COVID are still under investigation, its mechanism suggests it might help reduce ongoing symptoms. In this trial, all participants will receive Anktiva as the sole treatment, which researchers are carefully studying to assess its effectiveness and safety for patients. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing Long Covid, which refers to ongoing symptoms after recovering from COVID-19. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need to have persistent symptoms for a defined period.

Inclusion Criteria

History of at least one SARS-CoV-2 infection confirmed by a positive nucleic acid amplification test (NAAT) and/or a positive SARS-CoV-2 antigen rapid diagnostic test (RDT)

I am between 18 and 70 years old.

Not currently hospitalized

Exclusion Criteria

I do not have any active infections requiring treatment, except for COVID-19.

Known allergy to components used in the intervention formulation

Current alcohol or illicit drug use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 2 doses of Anktiva

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• N-803 (Anktiva)

Trial Overview The study is examining Anktiva (N-803), an IL-15 superagonist, for its safety and how well patients with Long Covid can tolerate it. Participants will receive up to two doses of Anktiva followed by examinations and tests to monitor effects.

How Is the Trial Designed?

Group I: N-803 Experimental Treatment 1 Intervention

All patients will be in this arm.

Who Is Running the Clinical Trial?

ImmunityBio, Inc.

Lead Sponsor

Trials

75

Recruited

5,000+

Richard Adcock

ImmunityBio, Inc.

Chief Executive Officer since 2024

Information not available

Dr. Patrick Soon-Shiong

ImmunityBio, Inc.

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07108036

A Study to Assess Anktiva in Patients With Long Covid-19. A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

2. ir.immunitybio.com ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-phase-2-study-anktivar-patients-long-covid

ImmunityBio Announces Phase 2 Study of ANKTIVA® in ... The safety and tolerability of ANKTIVA for long COVID is also being assessed in a separate Phase 2 study conducted at the University of ...

3. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/phase-trial-launches-anktiva-long-covid-patients

Phase II Trial Launches of Anktiva in Long COVID Patients ImmunityBio's Phase II study explores Anktiva's safety and efficacy in long COVID, focusing on lymphocyte counts and immune cell function. Long ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07123727

A Study to Examine Anktiva for the Treatment of COVID-19. This study will examine the safety and effectiveness of Anktiva in treating patients with Long ... Post-Acute COVID-19 Syndrome. ALT-803. Plan for Individual ...

5. contagionlive.com contagionlive.com/view/immunitybio-launches-phase-2-trial-of-anktiva-for-long-covid

ImmunityBio Launches Phase 2 Trial of ANKTIVA for Long ... First-in-class IL-15 agonist aims to address persistent post-COVID symptoms by enhancing immune clearance and restoring T cell memory.

6. immunitybio.com immunitybio.com/immunitybio-announces-phase-2-study-of-anktiva-in-patients-with-long-covid/

ImmunityBio Announces Phase 2 Study of ANKTIVA® in ... The safety and tolerability of ANKTIVA for long COVID is also being assessed in a separate Phase 2 study conducted at the University of ...