An open prospective randomized therapeutic trial using ANAKINRA or TOCILIZUMAB alone or in combination with RUXOLITINIB in severe stage 2b and 3 COVID-19 disease

Phase 1

• Conditions: COVID-19-associated disease; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-001754-21-FR
• Lead Sponsor: Assistance Publique Hôpitaux de Marseille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-17
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

-Patients older than 18 and younger than 75, potentially eligible for admission in ICU
-with proven infection with COVID19, using at least one positive pharyngeal polymerase chain reaction (PCR) test
-COVID19 infection at stage 2b or 3
-Ability to provide informed consent signed by study patient or legally acceptable representative

1/ Stage 2b: hypoxemia necessitating oxygen therapy>5l/min in order to maintain SpO2>94% (in conventional hospitalization unit or ICU) and CRP>150 mg/l
2/ Stage 3: Moderate or severe ARDS necessitating invasive mechanical ventilation with a PaO2/FiO2<200 during more than 24hours
3/Etremely severe stage 3:
a) very severe ARDS defined by invasive mechanical ventilation and requirement for veno-venous extracorporeal membrane oxygenation (ECMO)
b) or ARDS associated with at least on the following:
-Shock with requirement for continuous IV adrenalin infusion>3mg/h
-Myocarditis with cardiogenic shock
-Oligo-anuric acute renal insufficiency or requirement for extrarenal epuration
-Hemophagocytic syndrome associated with blood cytopenia or hyperferritinemia>5000 micrograms/l

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

-Patients younger than 18 or older than 75
-non-eligible for ICU
-Patients without legal rights
-No personal or familial consent
-Ongoing pregnancy
-Patient being treated for Anakinra, tocilizumab, or ruxolitinib for an underlying condition.
- Patient already included in another therapeutic trial to modulate inflammation
-Uncontrolled bacterial or fungal infection
-Hypersensitivity to anakinra
-Hypersensitivity to tocilizumab
- hypersensitivity to ruxolitinib

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified