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New treatment option for Long COVID
Official title A Study to Assess Anktiva in Patients With Long Covid-19.
ClinicalTrials.gov ID: NCT07108036
What this study is testing
What is N-803 (IL-15 Superagonist)?
N-803 (IL-15 Superagonist) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for long covid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- 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:
- Myocardial infarction within 90 days of screening; OR
- Coronary artery bypass procedure within 90 days of screening; OR
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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:
- Myocardial infarction within 90 days of screening; OR
- Coronary artery bypass procedure within 90 days of screening; OR
- 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. Note: Mild or...
- 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
- Baseline AST or ALT \> 1.5 × ULN
- Hemoglobin \< 9 d/dL
- CrCl \< 50 (estimated glomerular filtration rate)
- 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)...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.