Study of investigational medicinal product of CYT107 in patients with COVID-19 infection who have low number of lymphocytes in their blood (ILIAD 7 trial)
- Conditions
- ymphopenia and T cell exhaustion in COVID-19 patientsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001786-36-GB
- Lead Sponsor
- RevImmune SAS France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
1. A written, signed informed consent, or emergency oral consent, by the patient or the patient’s legally authorized representative, and the anticipated ability for participant to be re-consented in the future for ongoing Study participation
2. Men and women aged = 25 – 80 (included) years of age
3. Hospitalized patients with two absolute lymphocyte count (ALC) = 700 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION:
The FIRST time point should not be performed earlier than 48 hours after Hospitalization, thus first test dose can’t be administered before 72 hours after hospitalization (From this time point the investigator may choose to further postpone the commencement of IL-7 (CYT107) treatment according to patient’s clinical status)
4. Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at >4L per minute nasal cannula or greater to keep saturations >90%, non-invasive positive pressure ventilation (e.g., BIPAP), or patients intubated/ventilated for respiratory failure
5. Confirmed infection with COVID-19 by any acceptable test available/utilized at each site
6. Patient with medical insurance or government support
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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Pregnancy or breast feeding;
2. Refusal or inability to practice contraception regardless of the gender of the patient;
3. ALT and/or AST > 5 x ULN
4. Known, active auto-immune disease;
5. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing;
6. Patients with past history of Solid Organ transplant.
7. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
8. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours
9. Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300mg/day and/or anti-IL6 treatments like Tocilizumab or Sarilumab which should preferably be minimized
10. Patients with baseline Rockwood Clinical Frailty Scale = 6.
11. Patients under guardianship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method