NCT04435717

Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)

Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.

Detailed description

National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved. The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia. 78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1	Tocilizumab 20 MG/ML Intravenous (one dose)
DRUG	Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)	Tocilizumab 20 MG/ML Intravenous ( two doses)

Timeline

• Start date: 2020-05-04
• Primary completion: 2020-11-04
• Completion: 2021-02-10
• First posted: 2020-06-17
• Last updated: 2021-08-30

Locations

1 site across 1 country: Spain