Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19

Purpose

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

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04385849
Status
Terminated
Sponsor
ImmunityBio, Inc.