Treatment of COVID-19 Patients With Anti-interleukin Drugs

NCT04330638 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2023-03-14

Study results available
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Summary

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

Conditions

Interventions

OTHER

Usual Care

Usual Care

DRUG

Anakinra

Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first

DRUG

Siltuximab

Siltuximab will be given via single IV infusion at a dose of 11 mg/kg

DRUG

Tocilizumab

Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection

Sponsors & Collaborators

  • Belgium Health Care Knowledge Centre

    collaborator OTHER_GOV
  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Bart Lambrecht, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2020-12-20
Completion
2021-05-21
FDA Drug
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Entities

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 NCT04330638 on ClinicalTrials.gov