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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Collaborators: Dynamic Science S.L.; Roche Pharma AG

Criteria

Inclusion Criteria:

• Provide oral informed consent to participate in this study.

• At least 18 years of age.

• Diagnosed with COVID-19 pneumonia by RT-PCR.

• Have received the first dose of tocilizumab a maximum of two days before the inclusion or is candidate for tocilizumab treatment

• Hospitalized or admitted to ICU

Exclusion Criteria:

• The patient has any other medical condition or is receiving concomitant medication that could, in the opinion of the investigator, compromise the patient's safety or collected data

• Known severe allergic reactions to tocilizumab or other monoclonal antibodies

• Active acute and severe infections, including tuberculosis infection

• Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination