NCT04357444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 23, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
Last Updated

October 4, 2021

Status Verified

April 1, 2021

Enrollment Period

10 days

First QC Date

April 10, 2020

Last Update Submit

October 1, 2021

Conditions

COVID 19

Keywords

COVID-19SARS-CoV2Acute Respiratory Distress SyndromeLow dose of IL-2Immunotherapy

Outcome Measures

Primary Outcomes (1)

  • The PaO2/FiO2 ratio at D11

    at Day11

Secondary Outcomes (19)

  • Changes in Tregs between Baseline and Day 7 (expressed in %)

    at Day0 and Day7

  • Number of days alive with oxygen therapy within 28 days

    at Day28

  • Maximal oxygen rate within 28 days

    at Day28

  • Number of days alive free of invasive or non-invasive ventilation within 28 days

    At Day28

  • Number of days alive outside ICU within 28 days

    at Day28

  • +14 more secondary outcomes

Study Arms (2)

1: ILT101

EXPERIMENTAL

ILT-101 in Subcutaneous route

Drug: 1: ILT101

2: Placebo Comparator

PLACEBO COMPARATOR

Placebo in subcutaneous injections every day during 10 days

Drug: 2: Placebo Comparator

Interventions

1: ILT101DRUG

Subcutaneous injections, once-daily administration for 10 consecutive days.

1: ILT101
2: Placebo ComparatorDRUG

placebo in Subcutaneous route

2: Placebo Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Anesthésie Réanimation - Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • Kakh M, Doroudchi M, Talepoor A. Induction of Regulatory T Cells After Virus Infection and Vaccination. Immunology. 2025 May 7. doi: 10.1111/imm.13927. Online ahead of print.

    PMID: 40329764DERIVED

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jean-Michel CONSTANTIN

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 22, 2020

Study Start

October 23, 2020

Primary Completion

November 2, 2020

Study Completion

April 5, 2021

Last Updated

October 4, 2021

Record last verified: 2021-04

Locations

FR(1)