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 andtests.
Not Provided
Drug: N-803 (IL-15 Superagonist)
N-803 administered subcutaneously.
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.
University of California - San Francisco
San Francisco, California, United States
Investigator: Emily Fehrman
Contact: (650) 761-2163
Emily.Fehrman2@ucsf.edu
Investigator: Michael Peluso, MD
Kamin Personett
12673777737
kamin.personett@immunitybio.com
Not Provided