NCT04385849 is a Phase 1 clinical trial of N-803 in COVID-19, sponsored by ImmunityBio, Inc..

Who is sponsoring NCT04385849?

NCT04385849 is sponsored by ImmunityBio, Inc..

What drugs are being tested in NCT04385849?

Interventions in NCT04385849: N-803, Saline.

Is NCT04385849 still recruiting?

NCT04385849 is currently terminated. Last updated 5 September 2024.

Are results published for NCT04385849?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-05 · How we verify

NCT04385849

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Results posted Last updated 5 September 2024

What this trial tests

Phase 1 trial testing N-803 in COVID-19 in 1 participant. Terminated before completion.

Timeline

22 July 2020

Primary endpoint
25 July 2020

25 July 2020

Quick facts

Lead sponsor	ImmunityBio, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1
Start date	22 July 2020
Primary completion	25 July 2020
Estimated completion	25 July 2020
Sites	1 location across United States

Drugs / interventions tested

N-803 — full drug profile →
Saline

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

ImmunityBio, Inc. — full company profile →

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · 3 days

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

Group	Value	95% CI
Experimental Arm	1
Placebo Arm	0

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
Immunobiology and immunotherapy of COVID-19: A clinically updated overview.
Esmaeilzadeh A, Elahi R. · · 2021 · cited 59× · PMID 33022076 · DOI 10.1002/jcp.30076
The application of Interleukin-2 family cytokines in tumor immunotherapy research.
Zhou Y, Quan G, Liu Y, Shi N, et al · · 2023 · cited 32× · PMID 36936961 · DOI 10.3389/fimmu.2023.1090311
COVID-19 associated complications and potential therapeutic targets.
Monpara JD, Sodha SJ, Gupta PK. · · 2020 · cited 21× · PMID 32926918 · DOI 10.1016/j.ejphar.2020.173548
Immunomodulatory Therapeutic Proteins in COVID-19: Current Clinical Development and Clinical Pharmacology Considerations.
Ji P, Chen J, Golding A, Nikolov NP, et al · · 2020 · cited 6× · PMID 32779201 · DOI 10.1002/jcph.1729
Anti-Inflammation, Immunomodulation and Therapeutic Repair in Current Clinical Trials for the Management of COVID-19.
Li C, Zhao H, Cheng L, Wang B. · · 2021 · PMID 33824579 · DOI 10.2147/dddt.s301173

Verify or expand the search:

Other trials of N-803

Trials testing the same drug.

NCT05642195 — Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Ago · Phase 1, PHASE2 · suspended
NCT07574541 — Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 i · Phase 2 · not yet recruiting
NCT06161545 — Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcino · Phase 2 · recruiting
NCT06765902 — Immunotherapy Before and After Surgery · Phase 2 · not yet recruiting
NCT06061809 — N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma · Phase 2 · recruiting

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other ImmunityBio, Inc. trials

Trials by the same sponsor.

NCT07492888 — Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or · Phase 2 · not yet recruiting
NCT07524257 — ResQ1010-NSCLC: NAI + Chemoimmunotherapy vs Chemoimmunotherapy for First-Line Advanced/Metastatic NSCLC · Phase 3 · not yet recruiting
NCT07492875 — Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia · Phase 3 · not yet recruiting
NCT07488884 — Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combinat · Phase 1 · not yet recruiting
NCT07125872 — Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04385849 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ImmunityBio, Inc.
Last refreshed: 5 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04385849.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing