NCT04381052 is a Phase 2 clinical trial of Clazakizumab in COVID-19, sponsored by Columbia University.

Who is sponsoring NCT04381052?

NCT04381052 is sponsored by Columbia University.

What drugs are being tested in NCT04381052?

Interventions in NCT04381052: Clazakizumab, Placebo.

Is NCT04381052 still recruiting?

NCT04381052 is currently terminated. Last updated 8 April 2022.

Are results published for NCT04381052?

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

Last reviewed 2022-04-08 · How we verify

NCT04381052

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

Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

Terminated Phase 2 Results posted Last updated 8 April 2022

What this trial tests

Phase 2 trial testing Clazakizumab in COVID-19 in 1 participant. Terminated before completion.

Timeline

18 May 2020

Primary endpoint
1 April 2021

1 April 2021

Quick facts

Lead sponsor	Columbia University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1
Start date	18 May 2020
Primary completion	1 April 2021
Estimated completion	1 April 2021
Sites	1 location across United States

Drugs / interventions tested

Clazakizumab — full drug profile →
Placebo

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Columbia University

Who can join

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

Sponsor's own description

In this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25 mg or placebo.

Publications & conference data

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

The signal pathways and treatment of cytokine storm in COVID-19.
Yang L, Xie X, Tu Z, Fu J, et al · · 2021 · cited 429× · PMID 34234112 · DOI 10.1038/s41392-021-00679-0
Interleukin-6 blocking agents for treating COVID-19: a living systematic review.
Ghosn L, Chaimani A, Evrenoglou T, Davidson M, et al · · 2021 · cited 119× · PMID 33734435 · DOI 10.1002/14651858.cd013881
Neutrophils in COVID-19: Not Innocent Bystanders.
McKenna E, Wubben R, Isaza-Correa JM, Melo AM, et al · · 2022 · cited 76× · PMID 35720378 · DOI 10.3389/fimmu.2022.864387
Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
A Review of Treatment of Coronavirus Disease 2019 (COVID-19): Therapeutic Repurposing and Unmet Clinical Needs.
Chen PL, Lee NY, Cia CT, Ko WC, et al · · 2020 · cited 42× · PMID 33364959 · DOI 10.3389/fphar.2020.584956
Targeting Macrophages as a Therapeutic Option in Coronavirus Disease 2019.
Gracia-Hernandez M, Sotomayor EM, Villagra A. · · 2020 · cited 41× · PMID 33324210 · DOI 10.3389/fphar.2020.577571
Sulforaphane inhibits the expression of interleukin-6 and interleukin-8 induced in bronchial epithelial IB3-1 cells by exposure to the SARS-CoV-2 Spike protein.
Gasparello J, D'Aversa E, Papi C, Gambari L, et al · · 2021 · cited 40× · PMID 34033999 · DOI 10.1016/j.phymed.2021.153583
Recent updates in the clinical trials of therapeutic monoclonal antibodies targeting cytokine storm for the management of COVID-19.
Patel S, Saxena B, Mehta P. · · 2021 · cited 39× · PMID 33553708 · DOI 10.1016/j.heliyon.2021.e06158

Verify or expand the search:

Other trials of Clazakizumab

Trials testing the same drug.

NCT04494724 — Clazakizumab vs. Placebo - COVID-19 Infection · Phase 2 · unknown
NCT04348500 — Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19) · Phase 2 · completed
NCT04129931 — PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study · Phase 2 · completed
NCT03744910 — Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients · Phase 3 · terminated
NCT03380962 — Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant · Phase 1, PHASE2 · active not 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 Columbia University trials

Trials by the same sponsor.

NCT06558422 — Human Models of Selective Insulin Resistance: Pancreatic Clamp · Phase 1 · not yet recruiting
NCT07264582 — HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking · NA · not yet recruiting
NCT05992415 — Know Your Pressures NYC · NA · not yet recruiting
NCT05645211 — The AgRP and GH/IGF-1 Axis in Children · not yet recruiting
NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · 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 NCT04381052 (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 Columbia University
Last refreshed: 8 April 2022

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/NCT04381052.

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