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

NCT04385849 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: QUILT-COVID-19
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

  3 days

Study Arms (2)

Experimental Arm

EXPERIMENTAL

N-803 Recombinant human super agonist interleukin-15 (IL-15) complex

Biological: N-803

Placebo Arm

PLACEBO COMPARATOR

Sterile saline solution

Other: Saline

Interventions

N-803 BIOLOGICAL

Recombinant human super agonist interleukin-15 (IL-15) complex

Experimental Arm

Saline OTHER

Sterile saline solution

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Has a confirmed NEW score of 0-5.
• Has at least one of the following high-risk factors associated with a higher risk of COVID-19 progression:
• Age ≥ 60 years.
• Hypertension currently managed by at least 1 antihypertensive medication.
• Type 1 or 2 diabetes.
• Chronic obstructive pulmonary disease (COPD) diagnosed per medical history.
• Adequate respiratory and heart function, evidenced by the following laboratory results:
• Respiratory rate (RR) \< 20 breaths per minute (bpm).
• Heart rate (HR) \< 90 beats per minute (bpm).
• Arterial oxygen saturation (SaO2) \> 93% on room air.
• Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
• Ability to participate in required study visits and participate in adequate follow-up, as required by this protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

St. Francis

Lynwood, California, 90262, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

ALT-803; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The study is terminated early due to low enrollment. Effect of the study drug on efficacy was not analyzed.

Results Point of Contact

• Title: Lennie Sender, Chief Operating Officer
• Organization: ImmunityBio

lennie.sender@immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 13, 2020
• Study Start: July 22, 2020
• Primary Completion: July 25, 2020
• Study Completion: July 25, 2020
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)