Status:
COMPLETED
Low Dose of IL-2 In Acute Respiratory DistrEss Syndrome Related to COVID-19
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Iltoo Pharma
Conditions:
COVID 19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose is to demonstrate the efficacy of low-dose interleukin 2 (Ld-IL2) administration in improving clinical course and oxygenation parameters in patients with SARS-CoV2-related ARDS.
Detailed Description
About 25% of hospitalized patients with SARS-CoV2 infection presented life-threatening respiratory conditions. Of these, 60% met ARDS criteria leading to death in 25% to 63% of the cases. SARS-CoV2-re...
Eligibility Criteria
Inclusion
- Male or female, age ≥ 18 years
- Laboratory (RT-PCR) confirmed infection with SARS-CoV2
- Patient is either under invasive or non-invasive mechanical ventilation (including high flow nasal oxygen therapy).
- Diagnosis of ARDS according to the Berlin definition of ARDS
- Onset of ARDS \<96 hours
- Patient with French Social Security System
- A written informed consent by the designated substitute decision maker, if present. In the event of absence, the patient can be included by investigator's decision alone.
Exclusion
- Previous history of ARDS in the last month
- Chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance
- History of organ allograft.
- Active cancer
- Liver cirrhosis with basal Child and Pugh of C
- Pulmonary fibrosis
- Patient with end-of-life decision
- Patient not expected to survive for 24 hours
- Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
- Patient already enrolled in another interventional pharmacotherapy protocol on COVID-19
- Patient with known hypersensitivity to natural or recombinant Interleukin-2 or to any of the excipients
- Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 1.5x109/L, AST or ALT greater than 5 x ULN, platelets \<50,000 per mm3
- Use of chronic oral corticosteroids \> 10 mg prednisone equivalent a day for a non-COVID-19-related condition
- Current uncontrolled autoimmune disease
- Patients with uncontrolled suspected or known active systemic bacterial or fungal infections
- Patient with severe, uncontrolled pre-existing (chronic) organ failure (myocardial, hepatic or renal)
- Vaccination with live attenuated vaccines in the month preceding the inclusion
- Patient with burns to ≥ 15% of their total body surface area
- Patient receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
- Patient under legal protection (protection of the court, or in curatorship or guardianship).
Key Trial Info
Start Date :
October 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04357444
Start Date
October 23 2020
End Date
April 5 2021
Last Update
October 4 2021
Active Locations (1)
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1
Service Anesthésie Réanimation - Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013