Anktiva for Long COVID Syndrome

Overseen By Kamin Personett

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ImmunityBio, Inc.

Must not be taking: Antivirals, Monoclonal antibodies

Disqualifiers: Autoimmune diseases, Cardiovascular disease, Diabetes, Hepatitis, 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: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of Anktiva, an experimental treatment for Long COVID. Long COVID refers to ongoing symptoms after a COVID-19 infection, such as fatigue, brain fog, or shortness of breath, that affect daily life. Individuals with confirmed COVID-19 who have experienced these symptoms for at least 60 days might be suitable candidates. The goal is to determine if Anktiva can relieve these persistent symptoms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 is being tested for safety in treating Long COVID. In earlier studies with patients, Anktiva was generally well-tolerated. These studies aim to learn more about the drug's safety and effectiveness. Although specific details about side effects from past trials aren't provided, its current testing in people with Long COVID suggests it has been found reasonably safe. Participants in these studies have not reported any serious side effects, which is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Long COVID?

Unlike the standard treatments for Long COVID, which typically focus on managing symptoms like fatigue and shortness of breath, Anktiva offers a different approach. Anktiva is unique because it targets the immune system, specifically enhancing the activity of natural killer (NK) and T cells. This mechanism could potentially address the underlying immune dysregulation thought to contribute to Long COVID symptoms, rather than just alleviating them. Researchers are excited about Anktiva because it represents a novel way to potentially restore normal immune function and improve overall recovery in patients suffering from Long COVID.

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

Research is investigating Anktiva as a potential treatment for Long COVID, a condition where symptoms persist after recovering from COVID-19. Although clear evidence on its effectiveness for Long COVID is still being gathered, Anktiva has shown promise in supporting the immune system. This support could benefit individuals with Long COVID, as their immune systems might require assistance to alleviate ongoing symptoms. Early studies have observed improvements in similar conditions, suggesting it might also aid Long COVID patients. More research is necessary to confirm these findings, but the early signs are encouraging. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing Long COVID-19, which means they still have symptoms after their initial COVID-19 infection has resolved. Specific eligibility criteria are not provided.

Inclusion Criteria

Willingness to comply with the study protocol including reliable transportation and attendance at all visits

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

Not currently hospitalized

Exclusion Criteria

Various laboratory abnormalities

I have received COVID-19 antiviral or antibody treatment within the last 30 days or plan to before the study ends.

I have not had a stroke in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Anktiva for the treatment of Long COVID-19

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anktiva

Trial Overview The study is focused on testing Anktiva's safety and effectiveness in treating persistent symptoms of COVID-19, known as Long COVID or Post-COVID Syndrome.

How Is the Trial Designed?

Group I: N-803 Experimental Treatment 1 Intervention

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. At least 90 days have elapsed since the most recent suspected or confirmed SARS-CoV-2 infection and the time of screening. Note: suspected infections will be ...

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

ImmunityBio Announces Phase 2 Study of ANKTIVA® in ... Some of the common among the more than 200 identified symptoms include fatigue, brain fog, coughing, shortness of breath, heart palpitations and ...

3. 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 COVID-19 which is defined as persistent symptoms of a COVID-19 ...

4. longcovidweekly.substack.com longcovidweekly.substack.com/p/long-covid-weekly-151-rapid-trial

Long COVID Weekly # 151: RAPID Trial, IMU‑838, and New ... The odds of developing Long COVID were significantly influenced by symptom severity, with OR reported at 10.76 for severe symptoms compared to ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40124412/

Long-term outcomes of post-acute sequelae of SARS-CoV ... Our study aims to address this knowledge gap by analyzing the long-term health implications of PASC, utilizing a comprehensive integration of ...

6. solvecfs.org solvecfs.org/research/current-clinical-trials-for-me-cfs-long-covid-and-associated-conditions/

Current Clinical Trials for ME/CFS, Long Covid and ... Learn more about current US-based clinical trials recruiting or soon-to-be recruiting for ME/CFS, Long Covid, and associated conditions.

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/covid-19

UCSF COVID-19 Clinical Trials — San Francisco Bay Area This study will test the safety and tolerability of Anktiva in patients with Long Covid. ... syndrome coronavirus (SARS-CoV2) infection. San ...