Interleukin-1 (IL-1) and Interferon gamma (IFNg) inhibition during COVID 19 inflammation: Randomized, controlled study assessing efficacy and safety of Anakinra and Ruxolitinib

Phase 1

• Conditions: Covid-19 disease; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001963-10-FR
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne-sur-mer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Women and men, age = 18 years.
Confirmed respiratory tract SARS-coV-2 infection by at least one nasopharygeal sample or bronchoalveolar lavage PCR.
Patient hospitalized with clinical, biological and radiological features corresponding to following stages :
Stage 2B: corresponds to stage 2A, but with hypoxemia (Sa02 < 90 mmHg on room air,respiratory rate > 30/min) with biological inflammatory syndrome (CRP>150mg/l) .
- Stage 3: ARDS defined as mechanically ventilated patient with PaO2/FiO2 < 300 mmHg for more than 24h., acute respiratory insufficiency and a systemic hyper inflammatory syndrome which is sometimes complicated by hemophagocytic lymphohistiocytosis and multi-organ failure syndrome.
- Severe Stage 3 : ARDS as described above associated with any organ failure or syndrome such as :
•Shock with noradrenaline > 3mg/h
•Severe oligo-anuric renal insufficiency or necessitate renal dialysis
•Hepatocellular insufficiency or coagulopathy with factor V < 50%
•Myocarditis that caused severe heart failure and/or cardiogenic shock
•Hemophagocytic syndrome
High ferritin > 5000 ng/mL
Social Security affiliation or entitled to universal healthcare cover.
Subject or legal representative having expressed written consent after information.

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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

Pregnant or lactating women
Patients transplanted with solid organs or hematopoietic stem cells
HIV, HBV or HCV infection
Non treated bacterial or mycotic infection
Refusal to participate in the study
Patient under administrative or judicial supervision
Patient on exclusion period from another research
Patient receiving psychiatric treatment according to article L3112-1 and L3113-1 which do not apply to article L1121-8
Patient not able to read or understand french language which might prevent him from consenting to participate
Any condition which could compromise safety of the patient or interfere in the conduct of the research according to the investigator.

Study & Design

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