Status:
UNKNOWN
A Trial Using ANAKINRA, TOCILIZUMAB Alone or in Association With RUXOLITINIB in Severe Stage 2b and 3 of COVID19-associated Disease
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Covid19
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
COVID19-associated disease may have different clinical aspects classified in 3 stages. Some patients initially presenting with a non-hypoxemic viral pneumonia (stage 2a) may evolve toward a more sever...
Eligibility Criteria
Inclusion
- Patients older than 18 year up to 75 year-old maximum
- Eligible for resuscitation care in UCI
- with proven infection with COVID-19, using at least one positive pharyngeal polymerase chain reaction (PCR) test
- COVID19 infection pneumonia at
- Stage 2b: Hypoxemic pneumonia (respiratory rate \>30/min, Sat O2\<90 mm Hg in ambient air) associated with a marked biological inflammatory syndrome (CRP\>150mg/l) - or Stage 3: ARDS defined by a mechanically ventilated patient with a PaO2/FiO2 ratio \< 300 for more than 24 hours.
- or Advanced Stage 3: moderate to severe ARDS (PaO2/FiO2 \< 200 to PEEP of at least 8 cmH2O) on invasive mechanical ventilation associated with another organ failure or syndrome among : 1) Shock with norepinephrine dosage \> 3 mg/hour, 2) Acute renal oligo-anuric failure or requiring extra-renal lavage, 3) Hepatocellular failure or coagulopathy with factor V \< 50%, 4) Myocarditis causing acute heart failure and/or shock. , 5) Hemophagocytic syndrome, 6) Hyperferritinemia \> 5000 ng/mL
Exclusion
- Patients younger than 18 or older than 75 year-old,
- Pregnant or breastfeeding woman
- Patient for whom measures of therapeutic limitations have been issued (non-admission to intensive care unit)
- Patients treated with immunosuppressant/immunomodulators (Not only the concomitant administration of the following drugs prohibited in the protocol: other JAK inhibitors, corticosteroids, IL6 inhibitors).
- Patient already included in another interventional therapeutic trial
- Use of chronic oral corticosteroids \> 10 mg prednisone equivalent per day for non-COVID-19 related disease
- Uncontrolled autoimmune disease
- Patients with active, suspected or known active systemic bacterial, viral (excluding COVID-19) or fungal infections that are not controlled (not only HIV, HBV or HCV infection and untreated bacterial or mycotic infection)
- Patients with severe pre-existing uncontrolled organ dysfunction (heart, liver or kidney failure) not related to COVID-19
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04424056
Start Date
September 1 2020
End Date
November 1 2022
Last Update
June 23 2020
Active Locations (1)
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1
Assistance Publique Hôpitaux de Marseille
Marseille, France, 13005