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Immunomodulatory Agent

N-803 for COVID-19

Phase 1
Waitlist Available
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial is testing a new drug, N-803, to see if it is safe and can help fight COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Preliminary safety and efficacy evaluation of N-803
Preliminary safety and efficacy evaluation of N-803 by adverse event (AE) incidence
Preliminary safety and efficacy evaluation of N-803 by subject clinical status using a the 7-point ordinal scale.
Secondary outcome measures
Further evaluate efficacy of N-803 using changes to the National Early Warning Score (NEWS)
Further evaluate the safety of N-803 in hemoglobin
Further evaluate the safety of N-803 using platelets
+1 more

Side effects data

From 2022 Phase 2 trial • 20 Patients • NCT02989844
100%
Injection site reaction
100%
Platelet count decreased
100%
White blood cell decreased
100%
Neutrophil count decreased
100%
Anemia
100%
Hypertension
85%
Chills
75%
Hyperglycemia
75%
Dyspnea
60%
Fatigue
50%
Aspartate aminotransferase increased
50%
Rash maculo-papular
45%
Headache
40%
Fever
40%
Edema limbs
40%
Skin and subcutaneous tissue disorders - Other, specify
40%
Creatinine increased
35%
Nausea
35%
Upper respiratory infection
30%
Hypocalcemia
30%
Hypotension
25%
Lymphocyte count decreased
25%
Hyponatremia
25%
Alanine aminotransferase increased
25%
Diarrhea
20%
Hypermagnesemia
20%
Cough
20%
Vomiting
20%
Acute kidney injury
20%
Fall
20%
Hypoalbuminemia
20%
Gait disturbance
15%
Dizziness
15%
Infections and infestations - Other, specify
15%
Paronychia
10%
Abdominal pain
10%
Insomnia
10%
General disorders and administration site conditions - Other, specify
10%
Dry eye
10%
Weight loss
10%
Atrial Fibrillation
10%
Alkaline phosphatase increased
10%
Dry mouth
10%
Hypomagnesemia
5%
Myalgia
5%
Pain
5%
Pleural effusion
5%
Breast pain
5%
Vasovagal reaction
5%
Productive cough
5%
Pneumonitis
5%
Flu like symptoms
5%
Anorexia
5%
Lung infection
5%
Pericardial effusion
5%
Skin infection
5%
Peripheral sensory neuropathy
5%
Rash acneiform
5%
Pain in extremity
5%
Stomach pain
5%
Allergic reaction
5%
Erectile dysfunction
5%
Neck pain
5%
Sepsis
5%
Dysphagia
5%
Blood bilirubin increased
5%
Blurred Vision
5%
Generalized muscle weakness
5%
Back pain
5%
Infections and infestations - Other,
5%
Immune system disorders - Other,
5%
Respiratory failure
5%
Ear pain
5%
Atrial fibrillation
5%
Gastroesophageal reflux disease
5%
Gastrointestinal disorders - Other, specify
5%
Vulval infection
5%
Musculoskeletal and connective tissue disorder - Other, specify
5%
Bronchial obstruction
5%
Wheezing
5%
Nasal congestion
5%
Dry skin
5%
Mucositis oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-803

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment1 Intervention
N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
Group II: Placebo ArmPlacebo Group1 Intervention
Sterile saline solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inbakicept
Not yet FDA approved

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
63 Previous Clinical Trials
5,135 Total Patients Enrolled
8 Trials studying COVID-19
355 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19
2020. "Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04385849.
All > Covid
~0 spots leftby Apr 2025
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