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Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers

NCT04403685 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2020-08-26

No results posted yet for this study

Summary

The trial evaluates the efficacy and safety of Tocilizumab, which rapidly reduces the inflammation process through inhibition of IL-6 in patients with moderate to severe COVID-19 with increased inflammatory markers. There will be two arms in the trial, one receiving the best supportive care, and the other receiving it plus tocilizumab. Patients will be followed until Day 29 after randomization.

Conditions

Interventions

DRUG

Tocilizumab

Single-dose infusion of 8 mg/kg. Maximum dose of 800 mg.

Sponsors & Collaborators

  • Hospital do Coracao

    collaborator OTHER

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • Hospital Sirio-Libanes

    collaborator OTHER

  • Hospital Alemão Oswaldo Cruz

    collaborator OTHER

  • Brazilian Research In Intensive Care Network

    collaborator NETWORK

  • Hospital Moinhos de Vento

    collaborator OTHER

  • Brazilian Clinical Research Institute

    collaborator OTHER

  • Federal University of São Paulo

    collaborator OTHER

  • Beneficência Portuguesa de São Paulo

    lead OTHER

Principal Investigators

  • Viviane C Veiga, MD · Beneficência Portuguesa de Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2020-07-08
Completion
2020-07-21

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403685 on ClinicalTrials.gov