Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19
- Registration Number
- NCT04385849
- Lead Sponsor
- ImmunityBio, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
Not provided
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.
- Signs or symptoms of acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS)/shock, or cardiac failure; or need for supplemental oxygen.
- Inflammatory markers (C-reactive protein [CRP], lactate dehydrogenase [LDH], d-dimer, ferritin, and IL-6) > 1.5 × upper limit of normal (ULN).
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Arm Saline Sterile saline solution Experimental Arm N-803 N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events 3 days AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Francis
🇺🇸Lynwood, California, United States