ow dose of IL-2 In Acute respiratory DistrEss syndrome related to COVID-19

Phase 1

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

• Registration Number: EUCTR2020-001571-32-FR
• Lead Sponsor: Assistance Publique Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-Male or female, age = 18 years
-Laboratory (RT-PCR) confirmed infection with SARS-CoV2
-Patient is intubated and mechanically ventilated
-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.

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Previous history of ARDS in the last month
2.Chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance
3.Allogeneic bone marrow transplantation
4.Active cancer
5.Liver cirrhosis with basal Child and Pugh of C
6.Pulmonary fibrosis
7.Patient with end-of-life decision
8.Patient not expected to survive for 24 hours
9.Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
10.Patient already enrolled in another interventional pharmacotherapy protocol
on COVID-19
11.Patient with known hypersensitivity to natural or recombinant Interleukin-2 or to any of the excipients
12.Patient with burns to = 15% of their total body surface area
13.Patient receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
14. Patient under legal protection (protection of the court, or in curatorship or guardianship).

Study & Design

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