InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-20

Study Completion Date

2022-06-30

Brief Summary

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Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients

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Detailed Description

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Approximately forty-eight (48) participants will be randomized 1:1 to receive

(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7 administrations adjusted to patient's length of stay in the hospital) or (b) Intramuscular (IM) placebo (normal saline) at the same frequency.

The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement.

This cohort is dedicated to oncology patients

Conditions

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COVID-19 Lymphocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled of treatment vs placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo

Study Groups

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CYT107 Treatment

Intramuscular (IM) administration of CYT107 twice a week for 3 weeks

Group Type EXPERIMENTAL

CYT107

Intervention Type DRUG

IM administration at 10µg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay

Saline control

Intramuscular (IM) placebo (normal saline) at the same frequency

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Same number, volume and frequency of IM administration of saline

Interventions

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CYT107

IM administration at 10µg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay

Intervention Type DRUG

Placebo

Same number, volume and frequency of IM administration of saline

Intervention Type DRUG

Other Intervention Names

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Interleukin-7 Saline

Eligibility Criteria

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Inclusion Criteria

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. Patient receiving active or recent chemotherapy or immunotherapy (within 6 months) for cancer (and/or)
3. Patients who have received hematopoietic stem cell transplantation (for a diagnosis other than lymphoma) within the past 1 year (and/or)

Exclusion Criteria

5. Patients receiving hormonal therapy for cancer (and/or)
6. Patients who have undergone surgery or radiotherapy for cancer within the past 6 months
7. Patients with newly diagnosed (biopsy proven) malignancy who have not yet received cancer treatment but get COVID pneumonia in the interim (Incl. Criteria 11)
8. Men and women aged ≥ 25 - 80 (included) years of age
9. Hospitalized patients with one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, collected at baseline or no more than 72h before baseline .

From this time point the investigator may choose to further postpone the commencement of IL-7 (CYT107) treatment according to patient's clinical status.
10. 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
11. Confirmed infection with COVID-19 by any acceptable test available/utilized at each site
12. Willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure

1. Pregnancy or breast feeding;
2. ALT and/or AST \> 5 x ULN
3. Known, active auto-immune disease;
4. Patients with a history of lymphoid malignancy
5. Patients with any malignancy that is present at time of enrollment where treating physician expects life expectancy due to the underlying malignancy to be less than 6 months
6. Patients who received CAR-T cell therapy within the past 30 days or with unresolved cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS)
7. Patients with unresolved grade \> 2 toxicities from prior chemotherapy, immunotherapy, or CAR-T cell therapy
8. Patients with past history of Solid Organ transplant.
9. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
10. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation \>85% with maximal available therapy for \>6 hours
11. Patients with a mechanical ventilation support ≥ 7 days
12. Patients with chronic kidney dialysis
13. Patients with a SOFA score ≥ 9 at baseline
14. Patients with a BMI \> 40
15. Patients showing an increase of the NEWS2 score by more than 6 points during the screening/ baseline period (48 to 72 hrs prior to first administration)
16. Patients with hospital admission Rockwood Clinical Frailty Scale ≥ 6. (assessed as patient or proxy 4-week recall of chronic health and frailty status prior to COVID infection)

11\. Patients under guardianship

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No