Official Title
Single Arm Study to Evaluate the Safety of Nogapendekin Alfa Inbakicept (NAI) in Participants With Long COVID
Brief Summary

This study will examine the safety and effectiveness of Anktiva in treating patients withLong COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remainafter the infection is over.

Detailed Description

Not Provided

Recruiting
Long Covid
Long COVID Syndrome
Long Covid 19

Drug: Anktiva

600ug of NAI administered subcutaneously
Other Name: N-803,Nogapendekin Alfa Inbakicept,NAI

Eligibility Criteria

Inclusion Criteria:

- 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.

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, 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 examination, laboratory findings, and
vital signs.

- For male participants,

a. 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. 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 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.

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 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 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:

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.

- 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. Hemoglobin < 9 d/dL

4. Baseline AST or ALT > 1.5 × ULN

5. 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 70 Years
Countries
United States
Locations

Chan Soon-Schiong Institute for Medicine (CSSIFM)
El Segundo 5345860, California 5332921, United States

Investigator: Jaya Gill
Contact: 818-421-9775
jaya.gill@cssifm.org

Investigator: Chaitali Nangia, MD

Contacts

Kamin Personett
12673777737
kamin.personett@immunitybio.com

Not Provided

ImmunityBio, Inc.
NCT Number
MeSH Terms
Post-Acute COVID-19 Syndrome
ALT-803