Clinical Trial

Tocilizumab Treatment in Patients With COVID-19

Active, Not Recruiting Phase 2
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Summary
A phase II clinical trial will be carried out with the objective of studying the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection. Due to the high mortality of severe forms of SARS-CoV-2 and for ethical reasons, a control arm will not be included. Patients will be recruited by signing an informed consent and the baseline variables of interest will be recorded. Tocilizumab will be administered in one or two doses, depending on the case, and will be followed up for 30 days. The response to treatment, survival and evolution will be studied. Factors associated with improvement of ARDS and survival will be identified through multivariate analyzes. The results will be compared with those reported internationally.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-04-23; most recent amendment 2026-04-06.
Status change: Suspended → Active, Not Recruiting 2020-11-26
Status change: Recruiting → Suspended 2020-11-19
Trial Details
NCT Number NCT04363853
Lead Sponsor Instituto Nacional de Cancerologia de Mexico
Collaborators: Roche Pharma AG
Conditions Sars-CoV2
Enrollment 200 participants
Start Date 2020-06-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-09