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Tocilizumab Treatment in Patients With COVID-19

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v8
  2. Primary completion date: Dec 1, 2024 to Dec 1, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v7
  3. Primary completion date: Dec 1, 2023 to Dec 1, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v6
  4. Primary completion date: Jun 1, 2021 to Dec 1, 2023
    • Study completion date: Aug 1, 2021 to Dec 31, 2023
    • Interventions: Tocilizumab (Drug) to Tocilizumab 20 MG/ML (Drug)
    v5
  5. Trial status: Suspended to Active, Not Recruitingv4
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  1. Trial status: Recruiting to Suspended Sponsor's reason: Pending regulatory issues by Mexico´s health agency (CCINSHAE). Agency has requested further evidence for efficacy, therefore it was…
    • Site details revised
    v3
  2. Primary completion date: Jun 1, 2020 to Jun 1, 2021
    • Start date: Apr 1, 2020 to Jun 1, 2020
    • Study completion date: Aug 1, 2020 to Aug 1, 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04363853
Lead Sponsor Instituto Nacional de Cancerologia de Mexico
Collaborators: Roche Pharma AG
Conditions
(from sponsor)		 Sars-CoV2
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov