Trial | NCT04403685  Report issue

Title

Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers
Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 and Increased Inflammatory Markers: a Phase III Randomized Clinical Trial (COVID-19 Coalition Brazil VI) (TOCIBRAS)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    129
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.
Coalition VI (TOCIBRÁS) is a prospective phase III randomized controlled trial that evaluates the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers. This is a superiority open-label study with two arms. The control arm receives the best supportive care, and the experimental receives it plus tocilizumab. Randomization is done centrally by REDCap 1:1. Patients will be followed until Day 29 after randomization.
Study Started
May 08
2020
Primary Completion
Jul 08
2020
Study Completion
Jul 21
2020
Last Update
Aug 26
2020

Drug Tocilizumab

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

  • Other names: Actemra

Tocilizumab Experimental

Single-dose tocilizumab of 8 mg/kg (maximum dose of 800mg). Best supportive care.

Control arm No Intervention

Best supportive care.

Criteria 

Inclusion Criteria:

Male and females with 18 years and older
Confirmed diagnosis of SARS-CoV 2 infection
More than 3 days of symptoms related to COVID-19
Computed tomography (or Chest X-Ray) with COVID-19 alterations

Both of the criteria

Need for oxygen supplementation to keep SPO2 > 93% OR need for mechanical ventilation for less than 24 hours before the randomization

At least two of the following inflammatory tests above the cutoff :

D-dimer > 1,000 ng/mL
Reactive C protein > 5 mg/dL
Ferritin > 300 mg/dL
Lactate dehydrogenase > upper level limit

Exclusion Criteria:

Need for mechanical ventilation for 24 hours or more before the randomization
Hypersensitivity to tocilizumab
Patients without therapeutic perspective or in palliative care
Active non controlled infections
Other clinical conditions that contraindicate tocilizumab, according to the assistant physician
Low neutrophils count (< 0.5 x 109/L)
Low platelets count (< 50 x 109/L)
Liver disease, cirrhosis or elevated AST or ALT above 5 times the upper level limit
Renal disease with estimate glomerular filtration below 30 mL/min/1.72 m2 (MDRD or CKD-EPI scores)
Active diverticulitis
Breastfeeding women
Pregnancy
No Results Posted