Anktiva for Long COVID Treatment
This study is looking into Anktiva, a drug given by injection (600ug of NAI administered subcutaneously), to see if it can help people with Long COVID. Long COVID means you still have symptoms from a COVID-19 infection even after the infection is gone. We want to see how safe Anktiva is and if it causes any side effects. The study plans to enroll 40 adults between 18 and 70 years old who have a confirmed history of COVID-19. We will be tracking any side effects for 30 days after the last dose of Anktiva. The current status of the study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 40 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 30 days after their last study drug administration to monitor for side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07123727
A Study to Examine Anktiva for the Treatment of COVID-19.
Recruiting
PHASE2Ages 18–70InterventionalTreatmentImmunityBio, Inc.
~40 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Anktiva
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.
Measured over Through 30 days post final study drug administration.
+8 more outcomes measured
Conditions
NCT07123727
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Chan Soon-Schiong Institute for Medicine (CSSIFM)
El Segundo, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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,
For female participants,
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.
Exclusion
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.
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:
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.
What this trial measures
- Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.Through 30 days post final study drug administration.
- Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.Through 30 days post final study drug administration.
- Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.Through 30 days post final study drug administration.
- Incidence of abnormal changes in safety laboratory tests (CBC and CMP).Through the end of the study treatment period (approximately 75 days).
- Clinically important changes in vital signs such as temperature in degrees Fahrenheit.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.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).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.Through the end of the study treatment period (approximately 75 days).
- Clinically important changes in vital signs such as oxygen saturation in percentage.Through the end of the study treatment period (approximately 75 days).