Long COVIDPhase 2NCT07123727
A Study to Examine Anktiva for the Treatment of COVID-19.
A Phase 2 study testing Anktiva in people with Long COVID and Long COVID Syndrome, run by ImmunityBio, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Long COVID, Long COVID Syndrome, Long Covid 19
- What is being tested?
- Anktiva
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2025to Mar 2027
- 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.
- 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). 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, 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
- Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and/or everyday functioning AND
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- 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 examination, laboratory findings, and vital signs.
- For male participants,
- Participants with partners that are 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. 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.
- 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 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.
- 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 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 plan to receive such treatment before exiting the study.
- History of autoimmune disease including, but not limited, to celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.
- 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.
- 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
- Hemoglobin < 9 d/dL
- Baseline AST or ALT > 1.5 × ULN
- CrCl < 50 (estimated glomerular filtration rate)
- 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, 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, the presence of severe atopic conditions as assessed by the PI represents a significant risk for allergic reaction.
- Participation in a clinical trial with receipt of an investigational product within 28 days prior to planned INT1, except for 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
Chan Soon-Schiong Institute for Medicine (CSSIFM)
El Segundo, California, 90245
Jaya Gill, 310-955-4500, jaya.gill@cssifm.org
Chaitali Nangia, MD
About this study
Official title: Single Arm Study to Evaluate the Safety of Nogapendekin Alfa Inbakicept (NAI) in Participants With Long COVID
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
- Long COVID, Long COVID Syndrome, Long Covid 19
- Being tested
- Anktiva
- 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.
AnktivaDrug
Also called N-803, Nogapendekin Alfa Inbakicept, NAI
600ug of NAI administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| N-803 | Experimental | Not described Receives: Drug: Anktiva |
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 such as temperature in degrees Fahrenheit.
Measured: Through the end of the study treatment period (approximately 75 days).
Clinically important changes in vital signs such as heart rate in beats per minute.
Measured: Through the end of the study treatment period (approximately 75 days).
Clinically important changes in vital signs such as blood pressure in millimeters of mercury (mmHg).
Measured: Through the end of the study treatment period (approximately 75 days).
Clinically important changes in vital signs such as respiratory rate in breaths per minute.
Measured: Through the end of the study treatment period (approximately 75 days).
Clinically important changes in vital signs such as oxygen saturation in percentage.
Measured: Through the end of the study treatment period (approximately 75 days).
Secondary outcomes (1)
Percent increase or decrease change in the Absolute lymphocyte count (as measured on CBC) from Screening to End Of Study with various timepoints.
Measured: Through the end of the study treatment period (approximately 75 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start4 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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.
- 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
- 40 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
- NCT07123727
- Sponsor's protocol ID
- COVID-4.019-LONG
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2025
- Last updated
- 24 Sep 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Study to Evaluate the Safety of Nogapendekin Alfa Inbakicept (NAI) in Participants With Long COVID
- ClinicalTrials.gov ID
- NCT07123727
- Acronym / sponsor ID
- COVID-4.019-LONG
- Conditions
- Long COVID, Long COVID Syndrome, Long Covid 19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 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 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.
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: Anktiva |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 and < 70 years.
- 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). 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.
- Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening.
Key exclusion criteria (32 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 plan to receive such treatment before exiting the study.
- History of autoimmune disease including, but not limited, to celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.
- 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 |
|---|---|---|
| AnktivaAlso: N-803, Nogapendekin Alfa Inbakicept, NAI600ug of NAI 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 such as temperature in degrees Fahrenheit.
Time frame: Through the end of the study treatment period (approximately 75 days).
Clinically important changes in vital signs such as heart rate in beats per minute.
Time frame: Through the end of the study treatment period (approximately 75 days).
Clinically important changes in vital signs such as blood pressure in millimeters of mercury (mmHg).
Time frame: Through the end of the study treatment period (approximately 75 days).
Clinically important changes in vital signs such as respiratory rate in breaths per minute.
Time frame: Through the end of the study treatment period (approximately 75 days).
Clinically important changes in vital signs such as oxygen saturation in percentage.
Time frame: Through the end of the study treatment period (approximately 75 days).
1 secondary outcome
Percent increase or decrease change in the Absolute lymphocyte count (as measured on CBC) from Screening to End Of Study with various timepoints.
Time frame: Through the end of the study treatment period (approximately 75 days).
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 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 Anktiva in people with Long COVID and Long COVID Syndrome, 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 18 inclusion and 32 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 24 Sep 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 9 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 24 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.