Actively Recruiting
Interleukin-15 Superagonist Nogapendekin Alfa Inbakicept in Participants With Long Covid
Led by ImmunityBio, Inc. · Updated on 2026-05-11
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of Anktiva, an interleukin-15 superagonist called Nogapendekin Alfa Inbakicept, in patients experiencing Long Covid symptoms. This is a Phase 2 clinical trial sponsored by ImmunityBio, Inc. The study focuses on adults aged 18 to 70 who have confirmed Long Covid characterized by specific symptoms lasting at least 60 days and impacting quality of life. Participants will receive up to two subcutaneous doses of N-803 (IL-15 Superagonist) during the treatment period, which lasts approximately 75 days. All patients are in a single treatment arm. The study includes follow-up visits to monitor safety, collect laboratory tests including blood counts and chemistry, and assess patient-reported outcomes related to health and quality of life. Throughout the study, participants will undergo clinical exams, laboratory assessments such as CBC and CMP, and questionnaires including PROMIS-29 and EuroQoL quality of life measures. Researchers will track adverse events, vital signs, and viral markers in blood and stool over the treatment period and up to 30 days post final dose. The total duration of participation spans around 75 days, with safety and tolerability as the main focus.
CONDITIONS
Brief Title
A Study to Assess Anktiva in Patients With Long Covid-19.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and under 70 years
- Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus study
- History of at least one confirmed SARS-CoV-2 infection by test or participant attestation
- Clinical evidence of Long Covid with at least 2 new or worsened symptoms lasting at least 60 days
- Symptoms must impact quality of life or everyday functioning
- At least 90 days since most recent suspected or confirmed SARS-CoV-2 infection
- Not currently hospitalized
- Body mass index (BMI) between 18 and 50 kg/m2
- Stable health based on medical history, exam, labs, and vital signs within 28 days prior to screening
- For males with female partners of childbearing potential, agreement to use effective contraception and other related precautions
- For females engaging with male partners, not pregnant or breastfeeding and meeting contraception and pregnancy testing requirements
- 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 prior to study or plans to receive before exiting
- Plans to receive SARS-CoV-2 vaccine or booster within 14 days prior to study or before certain follow-up
- History of autoimmune disease such as celiac disease, rheumatoid arthritis, psoriasis, or inflammatory bowel disease
- Active cardiovascular disease including recent heart attack, bypass surgery, heart failure, or pulmonary hypertension
- Stroke within 3 months prior to study
- Active infections requiring treatment within 14 days prior to study except mild infections
- Major surgery within 3 months prior to study or planned during first 75 days
- Unplanned hospitalization over 24 hours within 28 days prior to screening
- Active or prior Hepatitis B or active Hepatitis C infection
- Certain laboratory abnormalities including low neutrophils, platelets, hemoglobin, or 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
- Known prior diagnoses of ME/CFS or dysautonomia unrelated to SARS-CoV-2
- Known allergy to study drug components or history of severe allergic reactions
- Participation in another investigational product trial within 28 days prior to study
- Current alcohol or illicit drug use that prevents participation
- Any condition that may compromise safety or data quality as judged by Investigator
AI-Screening
AI-Powered Screening
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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 the study drug N-803 administered subcutaneously as treatment for Long Covid-19.
Multiple visits during the treatment period
Duration - 30 to 45 days post final study drug administration
Participants are monitored for safety and treatment effects after completing the treatment period.
Follow-up visits through 30 days post final drug administration and additional visits up to 45 days after last administration
Trial Site Locations
Total: 1 location
1
University of California - San Francisco
San Francisco, California, United States, 94110
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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