Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19
Study Details
Study Description
Brief Summary
This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Arm N-803 Recombinant human super agonist interleukin-15 (IL-15) complex |
Biological: N-803
Recombinant human super agonist interleukin-15 (IL-15) complex
|
| Placebo Comparator: Placebo Arm Sterile saline solution |
Other: Saline
Sterile saline solution
|
Outcome Measures
Primary Outcome Measures
- Preliminary safety and efficacy evaluation of N-803 by adverse event (AE) incidence [2 weeks]
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
- Preliminary safety and efficacy evaluation of N-803 by subject clinical status using a the 7-point ordinal scale. [2 weeks]
The 7-point ordinal scale is an assessment of the clinical status and is performed as the first assessment on each study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
- Preliminary safety and efficacy evaluation of N-803 [2 weeks]
Preliminary safety and efficacy evaluation of N-803 by changes in lymphocyte counts. Incidence of lymphopenia (ie, absolute lymphocyte count [ALC] < 1000/mm3) during COVID-19 infection.
Secondary Outcome Measures
- Further evaluate efficacy of N-803 using changes to the National Early Warning Score (NEWS) [2 weeks]
National Early Warning Score (NEWS) is based on 7 clinical parameters: respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness.
- Further evaluate the safety of N-803 in hemoglobin [2 weeks]
Further evaluate the safety of N-803 using change from baseline in hemoglobin
- Further evaluate the safety of N-803 using platelets [2 weeks]
Further evaluate the safety of N-803 using change from baseline in platelets
- Further evaluate the safety of N-803 using white blood cell count [2 weeks]
Further evaluate the safety of N-803 using change from baseline in white blood cell count
Eligibility Criteria
Criteria
Inclusion Criteria
-
Age ≥ 18 years old.
-
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
-
Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp).
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Has a confirmed NEW score of 0-5.
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Has at least one of the following high-risk factors associated with a higher risk of
COVID-19 progression:
-
Age ≥ 60 years.
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Hypertension currently managed by at least 1 antihypertensive medication.
-
Type 1 or 2 diabetes.
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Chronic obstructive pulmonary disease (COPD) diagnosed per medical history.
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Adequate respiratory and heart function, evidenced by the following laboratory results:
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Respiratory rate (RR) < 20 breaths per minute (bpm).
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Heart rate (HR) < 90 beats per minute (bpm).
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Arterial oxygen saturation (SaO2) > 93% on room air.
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Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
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Ability to participate in required study visits and participate in adequate follow-up, as required by this protocol.
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Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of N-803. Non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the last dose of N-803. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.
Exclusion Criteria:
-
Shortness of breath or hypoxia defined by a ratio of partial pressure of arterial oxygen to the percentage of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg or signs of serious lower airway disease.
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Signs or symptoms of acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS)/shock, or cardiac failure; or need for supplemental oxygen.
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Inflammatory markers (C-reactive protein [CRP], lactate dehydrogenase [LDH], d-dimer, ferritin, and IL-6) > 1.5 × upper limit of normal (ULN).
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Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
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Pregnant and nursing women. A negative serum or urine pregnancy test during screening prior to the first dose must be documented before N-803 is administered to a female subject of child-bearing potential.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Francis | Lynwood | California | United States | 90262 |
Sponsors and Collaborators
- ImmunityBio, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QUILT-COVID-19