Treatment of COVID-19 Patients With Anti-interleukin Drugs

Sponsor
University Hospital, Ghent
Study ID
NCT04330638
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usual Care — OTHER
    Usual Care
  • Anakinra — DRUG
    Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
  • Siltuximab — DRUG
    Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
  • Tocilizumab — DRUG
    Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection

Study Details

The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome

Key Dates

Start date
Apr 3, 2020
Status verified
Feb 2023
Primary completion
Dec 20, 2020
Completion
May 21, 2021

Study Design

Enrollment
342 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Usual Care
  • Active Comparator: Anakinra
  • Active Comparator: Siltuximab
  • Active Comparator: Anakinra + Siltuximab
  • Active Comparator: Tocilizumab
  • Active Comparator: Anakinra + Tocilizumab

Primary Outcome Measure

Time to Clinical Improvement [ Time Frame: at day 15 ]

Related Studies