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

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-03-30

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 7administrations 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 excludes oncology patients on treatment

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 placeb

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

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

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

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

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. Men and women aged ≥ 25 - 80 (included) years of age
3. Hospitalized patients with two absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION:
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. Willingness and ability to practice contraception regardless of the gender of the patient during 5 month after last drug exposure
7. Private insurance or government / institution financial support (through CMS or other)

Exclusion Criteria

1. Pregnancy or breast feeding
2. ALT and/or AST \> 5 x ULN
3. Known, active auto-immune disease;
4. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing
5. Patients with past history of Solid Organ transplant
6. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load
7. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation \>85% with maximal available therapy for \>6 hours
8. Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300 mg/day equivalent hydrocortisone and/or anti-IL-6R treatments like Tocilizumab or Sarilumab or anti-IL-1 treatment like Anakinra which should preferably be minimized
9. Patients with baseline Rockwood Clinical Frailty Scale ≥ 6 at Hospital admission
10. 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)
11. Patients under guardianship

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No