COV201002: Eine prospektive, randomisierte, interventionelle Studie zur Bewertung der Wirksamkeit der entzündungshemmenden Moleküle Anakinra, Tocilizumab und Siltuximab bei Patienten mit COVID-19 mit Atemnot und Zytokinschock - COV-AID

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

Trial Description
Title Eine prospektive, randomisierte, interventionelle Studie zur Bewertung der Wirksamkeit der entzündungshemmenden Moleküle Anakinra, Tocilizumab und Siltuximab bei Patienten mit COVID-19 mit Atemnot und Zytokinschock - COV-AID

Participants (P)

Hospitalised adult patients with COVID-19 infection and acute hypoxia
Presence of hypoxia defined as ratio PaO2/FiO2 below 350 and signs of systemic cytokine release syndrome characterized by high serum ferritin, or high LDH or deep lymphopenia
Patients who have not been on mechanical ventilation for more than 24h before randomisation.

Intervention (I)

SoC + Anakinra (Group B)
SoC + Siltuximab (Group C)
SoC + Siltuximab + Anakinra (Group D)
SoC + Tocilizumab (Group E)
SoC + Tocilizumab + Anakinra (Group F)

Control (C)

Standard of Care (SOC) – (Group A)

Outcome (O)

Study if blockade of IL-6 +/- IL-1 to block the cytokine storm and acute lung injury in comparison with usual care reduces time to clinical improvement as defined by an increase of more than 2 on the 6 point ordinal scale or discharge from the hospital

Trial Design

2 by 2 factorial design
Prospective, multi-centre randomized, open label study

Sample Size

342 patients randomised

Trial duration

 13 months

Budget

€ 2.43 million

Status

Open to recruitment

 

Trial team

Sponsor

UZ Gent

Chief Investigator

Prof. Dr. Bart Lambrecht

 

Participating sites

16 hospitals in Belgium

External Partners

NAP

Dokumente
Protocol download here
Report

Q2 2021

Publication

 

Referenzen

Clinicaltrials.gov: NCT04330638

Webpage: 

Published on: 
2020/06/19