Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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-related ARDS is caused by a massive inflammatory cell infiltration leading to dysregulated cytokine/chemokine responses with lung immunopathological changes. To date, there is no treatment available. Regulatory T cells (Treg) are a subpopulation of CD4+ T cells playing a crucial role in the control of immune responses, in part by preventing excessive inflammation. Depletion of Treg cells in models of lung infection or after berylium exposure exacerbated lung inflammation. In contrast, a beneficial role for Treg during early ARDS and its resolution has been observed. Low-dose interleukin 2 (Ld-IL2) is the first therapy driving Treg-specific expansion and activation. Ld-IL2 was successfully tested in a wide range of preclinical models of inflammatory diseases, including beryllium-induced lung inflammation. Moreover, Ld-IL2 has been shown to be safe and free of serious adverse events when administered in patients with various autoimmune diseases. Importantly, in our previous work, we observed only very low concentrations of IL-2 in the blood (0.1 pg/mL [0.0-2.0]) as well as in the BAL supernatant (0.8 pg/mL [0.4-1.3]) collected from patients during the early phase of ARDS, suggesting that additional IL-2 could be beneficial for Treg expansion/activation. Our objective is therefore to investigate the therapeutic benefit of Ld-IL2 as a Treg inducer for controlling SARS-CoV2-related ARDS. After admission of patients to the intensive care unit at one of the recruiting centers, the eligibility criteria will be checked by the investigating physician and participation in the study will be proposed to the patient or parent/family member/trusted person. If the patient is unable to consent and there is no parent/family member/trusted person, the patient may be included in the emergency procedure. After inclusion (J0), the patient will be randomized to one of the 2 treatment arms (low dose IL-2 or placebo). The experimental treatment will be daily administered to the patient from D1 to D10. The patient will be monitored daily until D28 during hospitalization. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04357444
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 2
Start date October 23, 2020
Completion date April 5, 2021

See also
  Status Clinical Trial Phase
Completed NCT04333732 - CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION Phase 3
Completed NCT04357457 - Efficacy of Intravenous Almitrine in Reducing the Need for Mechanical Ventilation in Patients With Hypoxemic Acute Respiratory Failure Due to Covid-19-related Pneumonia Phase 3
Terminated NCT04435795 - Inhaled Ciclesonide for Outpatients With COVID19 Phase 2/Phase 3
Completed NCT04357834 - WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
Not yet recruiting NCT05052320 - Audiological Assessment of Recovered Covid 19 Subjects.
Withdrawn NCT04426344 - Core Warming of COVID-19 Patients N/A
Recruiting NCT05595031 - Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)
Terminated NCT04371978 - Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19 Phase 3
Terminated NCT04401410 - Anti-SARS Cov-2 T Cell Infusions for COVID 19 Phase 1
Completed NCT04445337 - Stellate Ganglion Blockade in COVID-19 Positive Patients N/A
Active, not recruiting NCT04374487 - Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications Phase 2
Completed NCT04403243 - COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19 Phase 2
Completed NCT04375644 - Impact of the COVID-19 Pandemic on the Quality of Psychological Life (COVID-PRO-IMPACT)
Completed NCT04394078 - Impact of COVID-19 Pandemic on Depression and Quality of Life
Recruiting NCT04407923 - Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context : Impact on Therapeutical Managment
Completed NCT04426305 - Community Health Workers Against COVID19 N/A
Withdrawn NCT04519411 - Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure N/A
Recruiting NCT04492514 - Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflation Phase 2
Completed NCT04403828 - Impact of COVID-19 on Personal Protection Among Dentist in Egypt
Completed NCT04399980 - Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation Phase 2