A Study to Assess Anktiva in Patients With Long Covid-19. (INTERRUPT_LC)

ImmunityBio

Status and phase

Not yet enrolling

Phase 2

Conditions

Long COVID

Treatments

Drug: N-803 (IL-15 Superagonist)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07108036

COVID-4.018-LONG

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
1. 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
2. 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
3. Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and/or everyday functioning AND
4. 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,

a. 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. 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:
1. 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.
2. 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.

Exclusion criteria

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:
1. Myocardial infarction within 90 days of screening; OR
2. Coronary artery bypass procedure within 90 days of screening; OR
3. Current heart failure with reduced ejection fraction (<45%); OR
4. 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:
1. ANC < 1,500 per mm3
2. Platelet count <100,000 per mm3
3. Baseline AST or ALT > 1.5 × ULN
4. Hemoglobin < 9 d/dL
5. CrCl < 50 (estimated glomerular filtration rate)
6. 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.