Back to Search
Start Over
TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol.
TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol.
- Source :
-
Contemporary clinical trials [Contemp Clin Trials] 2020 Nov; Vol. 98, pp. 106165. Date of Electronic Publication: 2020 Oct 06. - Publication Year :
- 2020
-
Abstract
- Background: Pneumonia is the most frequent complication of COVID-19, due to an aberrant host immune response that is associated with an acute respiratory distress syndrome, and, in most critical patients, with a "cytokine storm". IL-6 might play a key role in the cytokine storm and might be a potential target to treat severe and critical COVID-19. Tocilizumab is a recombinant humanized monoclonal antibody, directed against IL-6 receptor.<br />Methods: This multicentre study project includes a single-arm phase 2 study and a further parallel cohort, enrolling hospitalized patients with COVID-19 pneumonia and oxygen saturation at rest in ambient air ≤93% or requiring respiratory support. Patients receive tocilizumab 8 mg/kg (up to 800 mg) as one intravenous administration. A second administration (same dose) after 12 h is optional. Two-week and one-month lethality rates are the co-primary endpoints. Sample size planned for the phase 2 study is 330 patients. The parallel cohort will include patients who cannot enter the phase 2 study because being intubated from more than 24 h, or having already received tocilizumab, or the phase 2 study has reached sample size. Primary analysis will include patients enrolled in the phase 2 study. Results of the primary analysis will be validated in the prospective cohort of patients consecutively registered after phase 2 closure from March 20 to March 24, who were potentially eligible for the phase 2 study.<br />Conclusion: This trial aims to verify the safety and efficacy of tocilizumab in the Italian population with COVID-19 pneumonia and respiratory impairment. EudraCT Number: 2020-001110-38; Clinicaltrials.gov ID NCT04317092.<br /> (Copyright © 2020. Published by Elsevier Inc.)
- Subjects :
- Administration, Intravenous
Adult
Clinical Trials, Phase II as Topic
Drug Administration Schedule
Drug Monitoring
Female
Humans
Immunologic Factors administration & dosage
Immunologic Factors adverse effects
Male
Multicenter Studies as Topic
Treatment Outcome
Antibodies, Monoclonal, Humanized administration & dosage
Antibodies, Monoclonal, Humanized adverse effects
COVID-19 complications
COVID-19 immunology
COVID-19 physiopathology
COVID-19 therapy
Cytokine Release Syndrome drug therapy
Cytokine Release Syndrome etiology
Cytokine Release Syndrome immunology
Pneumonia, Viral drug therapy
Pneumonia, Viral etiology
Receptors, Interleukin-6 antagonists & inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 1559-2030
- Volume :
- 98
- Database :
- MEDLINE
- Journal :
- Contemporary clinical trials
- Publication Type :
- Academic Journal
- Accession number :
- 33031955
- Full Text :
- https://doi.org/10.1016/j.cct.2020.106165