Phase 1b, Randomized, Blinded, Placebo-controlled Study of the Safety of Therapeutic Treatment With an Immunomodulary Agent (N-803 in Adults With COVID-19

ImmunityBio, Inc.1 site in 1 country1 target enrollmentJuly 22, 2020

ConditionsCOVID-19

InterventionsN-803 Saline

DrugsN-803

Overview

Phase: Phase 1
Intervention: N-803
Conditions: COVID-19
Sponsor: ImmunityBio, Inc.
Enrollment: 1
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 22, 2020

End Date

July 11, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ImmunityBio, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.