Low Dose of IL-2 In Acute Respiratory DistrEss Syndrome Related to COVID-19

• Status: Completed
• Trial end date: 2021-04-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Iltoo Pharma

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).