Actively Recruiting
Single Arm Study to Evaluate the Safety of Nogapendekin Alfa Inbakicept (NAI) in Participants With Long COVID
Led by ImmunityBio, Inc. · Updated on 2026-05-13
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of Anktiva, also known as Nogapendekin Alfa Inbakicept (NAI), in people experiencing Long COVID, which means continuing symptoms after a COVID-19 infection has ended. This Phase 2 study aims to understand how this treatment may help patients with persistent symptoms that affect their quality of life. The study is sponsored by ImmunityBio, Inc. and focuses on adults aged 18 to 70 years with confirmed Long COVID symptoms lasting at least 60 days. Participants will receive 600 micrograms of Anktiva administered by a subcutaneous injection. The study is a single-arm trial, meaning all participants receive this treatment without comparison to a placebo or other drug. Treatment and monitoring will occur over approximately 75 days, including the time after the final dose to track safety and response. There are no placebo groups or blinding in this research. During the study, participants will attend visits for assessments including blood tests, vital signs monitoring (temperature, heart rate, blood pressure, respiratory rate, oxygen saturation), and symptom evaluations. Researchers will monitor for any treatment-related side effects or serious adverse events up to 30 days after the last dose. They will also assess changes in lymphocyte counts and other laboratory values. Participants should expect regular study visits and evaluations for safety and effectiveness over the treatment period.
CONDITIONS
Brief Title
A Study to Examine Anktiva for the Treatment of COVID-19.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and under 70 years
- History of at least one confirmed SARS-CoV-2 infection by positive NAAT or antigen test
- Clinical evidence of Long COVID confirmed by investigator assessment
- At least 2 new or worsened symptoms since COVID-19 infection that impact quality of life
- Symptoms present for at least 60 days before screening
- At least 90 days have passed since most recent COVID-19 infection
- Not currently hospitalized
- Body mass index (BMI) between 18 and 50 kg/m2
- Stable health within 28 days before screening
- For males with partners who can become pregnant, agreement to use contraception and inform partners
- For females who engage in intercourse with males, not pregnant or breastfeeding and agreement to contraceptive conditions
- Willingness and ability to comply with study visits and protocol
- Written informed consent obtained
You will not qualify if you...
- Received SARS-CoV-2 antiviral or monoclonal antibody within 30 days before first dose or plans to receive before study exit
- Plans to receive any SARS-CoV-2 vaccine or booster within 14 days before first dose or before study exit
- History of autoimmune diseases such as celiac disease, rheumatoid arthritis, psoriasis, or inflammatory bowel diseases
- Active cardiovascular disease including recent heart attack, bypass surgery, heart failure with reduced ejection fraction, or pulmonary hypertension
- Known stroke within 3 months prior to first dose
- Active bacterial, fungal, viral, or other infection needing treatment within 14 days before first dose
- Major surgery within 3 months before first dose or planned during first 75 days of study
- Unplanned hospitalization for more than 24 hours within 28 days before screening
- Active or prior Hepatitis B infection
- Active Hepatitis C infection (cured Hep C allowed)
- Laboratory abnormalities such as low white blood cell or platelet counts, low hemoglobin, elevated liver enzymes, or low kidney function
- Known or suspected HIV infection
- End stage kidney disease requiring dialysis
- Diabetes requiring systemic medication or insulin
- Severe liver impairment
- Moderate or severe immunocompromise including recent cancer treatment or organ transplant
- Prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome or dysautonomia unrelated to COVID-19
- Allergy to any study drug components or history of severe allergic reactions
- Participation in another investigational product trial within 28 days before first dose
- Current alcohol or illicit drug use that precludes 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 75 days
Participants receive 600ug of NAI administered subcutaneously as the study treatment.
Regular visits during the treatment period for safety and laboratory assessments
Duration - 30 days post final study drug administration
Participants are monitored for safety and adverse events for 30 days after the final study drug administration.
Visits as needed to assess safety outcomes
Trial Site Locations
Total: 1 location
1
Chan Soon-Schiong Institute for Medicine (CSSIFM)
El Segundo, California, United States, 90245
Actively Recruiting
Research Team
K
Kayleigh Russell
J
Jayson Garmizo
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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