ILIAD-7 Version 1.2 - Cohort UK [COVID-19] [UPH]
Research type
Research Study
Full title
Recombinant InterLeukin-7 (CYT107) to Improve clinical outcomes in lymphopenic pAtients with COVID-19 infection “ILIAD 7 trial”
IRAS ID
283184
Contact name
Manu Shankar-Hari
Contact email
Sponsor organisation
RevImmune SAS France
Eudract number
2020-001786-36
ISRCTN Number
ISRCTN15913068
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Lymphopenia (where patients have an abnormally low levels of white blood) and T cell exhaustion (which prevents the body from dealing with chronic viral infections) are major factors in deaths from COVID-19. This study will look at the ability of Recombinant InterLeukin-7 (CYT107) to reduce the amount of Intensive Care Unit treatment required and also reduce the death rate in COVID -19 patients with lymphopenia. We believe CYT107 will achieve this by reversing the lymphopenia. CYT107 will also help to avoid or reduce secondary infections. It is planned to include at least 48 patients with COVID-19 infection in a number of hospitals in UK. This study is the UK part of a large international study (ILIAD-7) conducted at the same time in other countries in Europe and North America. At the end of the study, it is planned to merge the data from the UK study with that of the other countries to allow a world-wide analysis of the expected clinical benefit. Patients will receive up to 5 intra-muscular administrations of IL-7 or placebo (one with no active ingredient) over 2 to 3 weeks during hospitalization. Treatment will be with a low dose of IL-7 (3 µg / kg) or placebo at the beginning of the study to make sure patients do not have significant side effects. The dose will then be increased to 10µg / kg. Patients will be monitored over the 2 to 3 week treatment period with a final follow-up check at 45 days. Neither the patient nor the research team nor the doctors will know which treatment is being given (double-blind research study). All patients will also receive standard hospital treatment throughout the study. The Study allows for treatment of patients who previously, or currently, receive drugs to prevent inflammation or anti- viral drugs.
REC name
London - Central Research Ethics Committee
REC reference
20/HRA/2191
Date of REC Opinion
6 May 2020
REC opinion
Further Information Favourable Opinion