Long COVIDPhase 2INTERRUPT_LCNCT07108036
A Study to Assess Anktiva in Patients With Long Covid-19.
A Phase 2 study testing N-803 (IL-15 Superagonist) in people with Long COVID, run by ImmunityBio, Inc. at 1 site in United States.
Trial summary
This study will test the safety and tolerability of Anktiva in patients with Long Covid. Eligible patients will receive up to 2 doses of Anktiva and have follow-up exams and tests. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Long COVID
- What is being tested?
- N-803 (IL-15 Superagonist)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and < 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. Any adult who has been infected with SARS-CoV-2 or has ever received or is eligible to receive a SARS-CoV-2 vaccination, and who is able to provide written informed consent, is eligible to participate in LIINC.
- History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and/or a positive SARS-CoV-2 antigen rapid diagnostic test (RDT). Written proof of the test will be requested but is not required as long as the participant attests to the positive test. Those with only suspected but unconfirmed infections are not eligible for this study.
- Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.
- At least 2 symptoms or at least 1 severe symptom as assessed by the study team (see list) that are new or worsened since the time of a SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the PI. At least 2 symptoms from those listed here must be present: systemic symptoms (eg, fatigue, chills, post-exertional malaise), neurocognitive symptoms (eg, trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia symptoms, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (eg, chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (eg, muscle aches, joint pain), gastrointestinal symptoms (eg, nausea, diarrhea). Although other symptoms (eg, skin rash, hair loss, mental health symptoms, trouble with smell/taste, genitourinary symptoms) will be recorded and tracked, at least 2 core symptoms listed above must be present. Note: the 2 symptoms can be from within the same category (for example, brain fog and headache) AND
- Symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening AND
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- Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and/or everyday functioning AND
- 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 determined based upon assessment by the study Investigators.
- Not currently hospitalized.
- Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening.
- In otherwise stable health, as assessed by the Investigator within 28 days prior to screening, based on medical history, physical assessment, laboratory findings, and vital signs.
- For male participants,
- Participants with partners that are women of childbearing potential (WOCBP) are strongly advised to inform their partners and must agree to use effective contraception from study entry (defined as INT1) through 7 months after the last dose of study intervention. Effective methods of contraception are described in Appendix 2. Participants with pregnant partners must agree to use condoms during vaginal intercourse from study entry (defined as INT1) through 14 days after the last dose of study intervention administration. Participants assigned male sex at birth must agree to refrain from sperm donation from study entry through 14 days after the last dose of study intervention administration.
- For female participants,
- A female participant who engages in sexual intercourse with male partners is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies: i. Is not a WOCBP OR ii. All of the following apply:
- Is a WOCBP and is using a contraceptive method that is effective as described in Appendix 1 from -21 days from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration. She must also agree not to donate her eggs (ova, oocytes) for the purpose of reproduction from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration.
- A WOCBP must have a negative urine pregnancy test within 24 hours prior to all doses of study intervention. If a urine pregnancy test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test must be negative.
- Willingness and ability to comply with the study protocol. This includes reliable transportation and sufficient time to attend all visits.
- Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.
Who cannot join
- Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the study.
- Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to planned INT1 or before FU2.5 following planned INT1.
- History of autoimmune disease including, but not limited to, celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
- Active cardiovascular disease, defined as known prior:
- Myocardial infarction within 90 days of screening; OR
- Coronary artery bypass procedure within 90 days of screening; OR
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- Current heart failure with reduced ejection fraction (<45%); OR
- Current pulmonary arterial hypertension.
- Known stroke within 3 months prior to planned INT1.
- Known active bacterial, fungal, viral, or other infection besides SARS-CoV-2 requiring treatment within the 14 days prior to INT1 and meeting criteria for systemic involvement upon review by the PI. Note: Mild or limited infections such as uncomplicated urinary tract or yeast infections, sexually transmitted infections, and mild dermatophyte infections may be reviewed with the Safety Monitoring Committee chair but are not exclusionary.
- Major surgery within 3 months prior to planned INT1 or planned major surgery during the first 75 days following planned INT1.
- History of unplanned hospitalization for >24 hours within 28 days prior to Screening.
- Active or prior Hepatitis B (Hep B) infection (defined as Hep B core antibody (cAb) and/or Hep B surface antigen (sAg) positive. Note: Prior hepatitis B is exclusionary even in the absence of ongoing infection.
- Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA). Note: Those with cured Hep C (Ab positive or indeterminate but negative Hep C RNA) will remain eligible.
- Laboratory abnormalities including:
- ANC < 1,500 per mm3
- Platelet count <100,000 per mm3
- Baseline AST or ALT > 1.5 × ULN
- Hemoglobin < 9 d/dL
- CrCl < 50 (estimated glomerular filtration rate)
- ALC < 1,000 per mm3
- Known or suspected HIV infection.
- End stage kidney disease requiring dialysis.
- History of Type I or Type 2 Diabetes mellitus requiring systemic medication or insulin.
- Severe hepatic impairment (Child-Pugh Class C).
- Moderate or severe immunocompromise, according to the current National Institutes of Health (NIH) COVID-19 Treatment Guidelines as of March 6, 2023. The detailed list is in Appendix 2, and includes the following: (a) receiving active treatment for solid tumor or hematologic malignancy, including use of systemic chemotherapy for treatment of cancer within the year prior to screening, (b) prior solid-organ transplant with active immunosuppressive therapy, (c) CAR-T cell therapy or hematopoietic cell transplant, on immunosuppressive therapy or transplant within the prior 2 years, (d) primary immunodeficiency syndromes, advanced or untreated HIV infection (see above), (f) on active high-dose corticosteroids (ie, ≥ 20mg prednisone or equivalent daily per day for ≥ 2 weeks).
- Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.
- Known prior diagnosis of dysautonomia, preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.
- Known allergy to any components used in the formulation of the intervention.
- History of anaphylaxis or similar significant allergic reaction to prescription or non-prescription drugs or food products. Similarly, presence of severe atopic conditions as assessed by the PI represents significant risk for allergic reaction.
- Participation in a clinical trial with receipt of an investigational product within 28 days prior to planned INT1, with the exception of exploratory PET imaging studies related to Long COVID.
- Current alcohol or illicit drug use as determined by the Investigator to preclude participation.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California - San Francisco
San Francisco, California, 94110
Emily Fehrman, (650) 761-2163, Emily.Fehrman2@ucsf.edu
Michael Peluso, MD
About this study
Official title: Interleukin-15 Superagonist Nogapendekin Alfa Inbakicept in Participants With Long Covid.
This study will test the safety and tolerability of Anktiva in patients with Long Covid. Eligible patients will receive up to 2 doses of Anktiva and have follow-up exams and tests.
- Conditions
- Long COVID
- Being tested
- N-803 (IL-15 Superagonist)
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-803 (IL-15 Superagonist)Drug
N-803 administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| N-803 | Experimental | All patients will be in this arm. Receives: Drug: N-803 (IL-15 Superagonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.
Measured: Through 30 days post final study drug administration.
Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.
Measured: Through 30 days post final study drug administration.
Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.
Measured: Through 30 days post final study drug administration.
Incidence of abnormal changes in safety laboratory tests (CBC and CMP).
Measured: Through the end of the study treatment period (approximately 75 days)
Clinically important changes in vital signs.
Measured: Through the end of the study treatment period (approximately 75 days)
Secondary outcomes (5)
Change in the ALC from Screening, INT1, FU1.3, INT2, FU2.3, FU2.4, FU2.5, and EOS.
Measured: Through the study treatment period (approximately 75 days).
Change in patient-reported outcomes (PROs) PROMIS-29 score from Baseline to FU2.5 (45 days following last NAI administration).
Measured: 45 days following last NAI administration.
Change in other assessments (eg, EuroQoL Quality of Life) from baseline, intervention 2, FU2.3 (2 weeks after last NAI administration), FU2.5, and EOS.
Measured: Through the study treatment period (approximately 75 days).
Proportion of participants with no detection of SARS-CoV-2 plasma remnants (ie viral detection by reverse transcriptase-polymerase chain reaction [RTPCR]) compared to baseline at FU2.5 and EOS.
Measured: Through the study treatment period (approximately 75 days).
Proportion of participants with reduced SARS-CoV-2 RNA in stool approximately 30 days post NAI administration.
Measured: 30 days post NAI administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start14 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108036
- Sponsor's protocol ID
- COVID-4.018-LONG
- Acronym
- INTERRUPT_LC
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-15 Superagonist Nogapendekin Alfa Inbakicept in Participants With Long Covid.
- ClinicalTrials.gov ID
- NCT07108036
- Acronym / sponsor ID
- INTERRUPT_LC / COVID-4.018-LONG
- Conditions
- Long COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the safety and tolerability of Anktiva in patients with Long Covid. Eligible patients will receive up to 2 doses of Anktiva and have follow-up exams and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-803 | Experimental | Drug: N-803 (IL-15 Superagonist)All patients will be in this arm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 and < 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. Any adult who has been infected with SARS-CoV-2 or has ever received or is eligible to receive a SARS-CoV-2 vaccination, and who is able to provide written informed consent, is eligible to participate in LIINC.
- History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and/or a positive SARS-CoV-2 antigen rapid diagnostic test (RDT). Written proof of the test will be requested but is not required as long as the participant attests to the positive test. Those with only suspected but unconfirmed infections are not eligible for this study.
- Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.
- Not currently hospitalized.
Key exclusion criteria (33 listed)
- Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the study.
- Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to planned INT1 or before FU2.5 following planned INT1.
- History of autoimmune disease including, but not limited to, celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
- Active cardiovascular disease, defined as known prior:
- Known stroke within 3 months prior to planned INT1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-803 (IL-15 Superagonist)N-803 administered subcutaneously. | Drug | N-803 |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.
Time frame: Through 30 days post final study drug administration.
Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.
Time frame: Through 30 days post final study drug administration.
Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.
Time frame: Through 30 days post final study drug administration.
Incidence of abnormal changes in safety laboratory tests (CBC and CMP).
Time frame: Through the end of the study treatment period (approximately 75 days)
Clinically important changes in vital signs.
Time frame: Through the end of the study treatment period (approximately 75 days)
5 secondary outcomes
Change in the ALC from Screening, INT1, FU1.3, INT2, FU2.3, FU2.4, FU2.5, and EOS.
Time frame: Through the study treatment period (approximately 75 days).
Change in patient-reported outcomes (PROs) PROMIS-29 score from Baseline to FU2.5 (45 days following last NAI administration).
Time frame: 45 days following last NAI administration.
Change in other assessments (eg, EuroQoL Quality of Life) from baseline, intervention 2, FU2.3 (2 weeks after last NAI administration), FU2.5, and EOS.
Time frame: Through the study treatment period (approximately 75 days).
Proportion of participants with no detection of SARS-CoV-2 plasma remnants (ie viral detection by reverse transcriptase-polymerase chain reaction [RTPCR]) compared to baseline at FU2.5 and EOS.
Time frame: Through the study treatment period (approximately 75 days).
Proportion of participants with reduced SARS-CoV-2 RNA in stool approximately 30 days post NAI administration.
Time frame: 30 days post NAI administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-803 (IL-15 Superagonist) in people with Long COVID, run by ImmunityBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayleigh Russell (424.539.2412, Kayleigh.Russell@ImmunityBio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration. (time frame: Through 30 days post final study drug administration.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.