Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07123727

A Study to Examine Anktiva for the Treatment of COVID-19.

Led by ImmunityBio, Inc. · Updated on 2026-05-13

40

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 infection that remain after the infection is over.

CONDITIONS

Official Title

A Study to Examine Anktiva for the Treatment of COVID-19.

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to less than 70 years
  • History of at least one confirmed SARS-CoV-2 infection by NAAT or antigen test
  • Clinical evidence of Long COVID confirmed by investigator
  • At least 2 new or worsened symptoms since SARS-CoV-2 infection or at least 1 severe symptom, lasting at least 60 days
  • Symptoms reported as bothersome and impacting quality of life or daily functioning
  • At least 90 days elapsed since most recent suspected or confirmed SARS-CoV-2 infection
  • Not currently hospitalized
  • Body mass index (BMI) between 18 and 50 kg/m2 inclusive
  • Otherwise stable health as assessed by investigator within 28 days prior to screening
  • For males with partners who can become pregnant, agreement to use effective contraception during study and 7 months after last dose
  • For females sexually active with males, not pregnant or breastfeeding and agreement to contraception and pregnancy testing as required
  • Willingness and ability to comply with study protocol and attend all visits
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Received SARS-CoV-2 antiviral or monoclonal antibody within 30 days prior to planned treatment or plan to receive before study exit
  • Plans to receive any SARS-CoV-2 vaccine or booster within 14 days prior to planned treatment or before study exit
  • History of autoimmune diseases including celiac disease, rheumatoid arthritis, psoriasis, inflammatory bowel diseases
  • Active cardiovascular disease such as recent myocardial infarction, recent coronary artery bypass, heart failure with reduced ejection fraction, or pulmonary arterial hypertension
  • Stroke within 3 months prior to planned treatment
  • Active infection other than SARS-CoV-2 requiring treatment within 14 days prior to treatment
  • Major surgery within 3 months prior to treatment or planned major surgery during first 75 days after treatment
  • Unplanned hospitalization over 24 hours within 28 days prior to screening
  • Active or prior Hepatitis B infection
  • Active Hepatitis C infection; cured Hepatitis C allowed
  • Laboratory abnormalities including low ANC, low platelet count, low hemoglobin, elevated liver enzymes, or reduced kidney function
  • Known or suspected HIV infection
  • End stage kidney disease requiring dialysis
  • Diabetes requiring systemic medication or insulin
  • Severe liver impairment (Child-Pugh Class C)
  • Moderate or severe immunocompromise including recent cancer treatment, organ transplant, immunodeficiency syndromes, high-dose corticosteroids
  • Prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome not related to COVID-19
  • Prior diagnosis of dysautonomia not related to COVID-19
  • Allergy to components of study drug or history of severe allergic reactions
  • Participation in clinical trial with investigational product within 28 days prior to treatment except certain imaging studies
  • Current alcohol or illicit drug use interfering with participation
  • Any condition that investigator believes would compromise safety or data quality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chan Soon-Schiong Institute for Medicine (CSSIFM)

El Segundo, California, United States, 90245

Actively Recruiting

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Research Team

K

Kayleigh Russell

CONTACT

J

Jayson Garmizo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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