Clinical Trial to Evaluate the Effectiveness and Safety of Tocilizumab for Treating Patients With COVID-19 Pneumonia
Status:
Completed
Trial end date:
2020-12-23
Target enrollment:
Participant gender:
Summary
At present, no treatment has been approved for COVID-19. However, in light of the increased
interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected
patients due to its potential benefit, the Spanish Agency for Medicine and Health Products
(Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) have initiated the
controlled distribution of the drug. Tocilizumab is indeed proposed as a potential treatment
for severe COVID-19 in Spain. Based on the positive results of tocilizumab in the treatment
of COVID-19 patients and the experience of tocilizumab in inducing rapid reversal of CSS in
other pathologies several clinical trials and observational studies are being conducted to
assess the effectiveness and safety of tocilizumab in COVID-19 patients. Further studies with
a large sample size are required to confirm the effectiveness of tocilizumab in patients with
COVID-19 pneumonia.
The need for the management of severe COVID-19 disease is imperative, and every effort should
be made to collect relevant clinical outcomes. The aim of the present study is to evaluate
the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia who are
currently hospitalized or admitted to ICU by describing improvement of respiratory function
and mortality rate. This large real-world cohort therefore provides a unique opportunity to
study this potential medicine during the current emergency situation, and support the
findings from other ongoing clinical trials and observational studies, such as the
Roche-sponsored Phase III study that is planned to start early April.