NCT05164133 is a Phase 1 clinical trial of Tocilizumab in COVID-19, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT05164133?

NCT05164133 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT05164133?

Interventions in NCT05164133: Tocilizumab.

Is NCT05164133 still recruiting?

NCT05164133 is currently completed. Last updated 29 April 2024.

Last reviewed 2024-04-29 · How we verify

NCT05164133

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

A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19

Completed Phase 1 Last updated 29 April 2024

What this trial tests

Phase 1 trial testing Tocilizumab in COVID-19 in 2 participants. Completed in 27 March 2024.

Timeline

10 June 2022

Primary endpoint
27 March 2024

27 March 2024

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	10 June 2022
Primary completion	27 March 2024
Estimated completion	27 March 2024
Sites	25 locations across France, Italy, South Africa, Greece, United Kingdom, Germany, Poland, Spain

Drugs / interventions tested

Tocilizumab (tocilizumab) — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Under 17, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Repurposing of drugs targeting the cytokine storm induced by SARS-CoV-2.
Ng WH, Tang PCH, Mahalingam S, Liu X. · · 2023 · cited 7× · PMID 36394425 · DOI 10.1111/bph.15987

Verify or expand the search:

Other trials of Tocilizumab

Trials testing the same drug.

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NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis · not yet recruiting
NCT06381661 — Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Tra · Phase 2 · not yet recruiting
NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · 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 Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · 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 NCT05164133 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Hoffmann-La Roche
Last refreshed: 29 April 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/NCT05164133.

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