COVID-19
Conditions
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.
Interventions
BIOLOGICALN-803
Recombinant human super agonist interleukin-15 (IL-15) complex
OTHERSaline
Sterile saline solution
Sponsors
ImmunityBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. 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). 4. Has a confirmed NEW score of 0-5. 5. Has at least one of the following high-risk factors associated with a higher risk of COVID-19 progression: 1. Age ≥ 60 years. 2. Hypertension currently managed by at least 1 antihypertensive medication. 3. Type 1 or 2 diabetes. 4. Chronic obstructive pulmonary disease (COPD) diagnosed per medical history. 6. Adequate respiratory and heart function, evidenced by the following laboratory results: 1. Respiratory rate (RR) \< 20 breaths per minute (bpm). 2. Heart rate (HR) \< 90 beats per minute (bpm). 3. Arterial oxygen saturation (SaO2) \> 93% on room air. 7. Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol. 8. Ability to participate in required study visits and participate in adequate follow-up, as required by this protocol. 9. 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
1. 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. 2. Signs or symptoms of acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS)/shock, or cardiac failure; or need for supplemental oxygen. 3. Inflammatory markers (C-reactive protein \[CRP\], lactate dehydrogenase \[LDH\], d-dimer, ferritin, and IL-6) \> 1.5 × upper limit of normal (ULN). 4. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 3 days | AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Arm N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex | 1 |
| Placebo Arm Sterile saline solution
Saline: Sterile saline solution | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Experimental Arm |
|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 0 | 70 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Number of Participants With Adverse Events
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time frame: 3 days
Population: All randomized subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Arm | Number of Participants With Adverse Events | 1 Participants |
| Placebo Arm | Number of Participants With Adverse Events | 0 Participants |