InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection FR BL Cohort

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

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 two 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 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safety review took place after the first 12 patients. Since the CYT107 was well tolerated, the test dose (3 μg/kg) ceased and the initial dose became the same as the rest of the doses (10 μg/kg). So, the remaining patients will be randomized to receive 5 administrations of (a) CYT107 at 10 μg/kg every 3 to 4 days for 2 weeks 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

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

Double blind

Study Groups

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CYT107

Intra-muscular administration of CYT107 twice a week for a total of 5 administrations

Group Type EXPERIMENTAL

Interleukin-7

Intervention Type DRUG

Intramuscular (IM) administration of CYT107 at 3 μg/ kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or

Saline

Intramuscular (IM) administration of saline at the same volume and same time for a total of 5 administrations

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Interleukin-7

Intramuscular (IM) administration of CYT107 at 3 μg/ kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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CYT107 Saline

Eligibility Criteria

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Inclusion Criteria

* 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
* Men and women aged ≥ 25 - 80 (included) years of age
* Hospitalized patients with one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, collected at baseline or no more than 72h before baseline
* 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) for respiratory failure
* Confirmed infection with COVID-19 by any acceptable test available/ utilized at each site
* Patient with medical insurance or government support

Exclusion Criteria

* Pregnancy or breast feeding;
* Refusal or inability to practice contraception regardless of the gender of the patient;
* ALT and/or AST \> 5 x ULN
* Known, active auto-immune disease;
* Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing;
* Patients with past history of Solid Organ transplant.
* Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
* Patients whose respiratory condition is showing significant deterioration as indicated by:

* 8a requirement for an increase in inspired oxygen concentrations of 20% or more over the past 24 hours to maintain SpO2 at greater than or equal to 88%
* 8b or need for invasive mechanical ventilation
* 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)
* Patients with chronic kidney dialysis
* Patients with a SOFA score ≥ 9 at baseline
* Patients with a BMI \> 40
* Patients receiving any agent with immune suppressive effects,such as anti-IL6 treatments like Tocilizumab or Sarilumab which should preferably be minimized
* Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) \< 1.5x109/L, Platelets \< 50,000 per mm3
* Patients with uncontrolled pre-existing severe major organ dysfunction (cardiac, liver or renal failure)
* Vaccination with live attenuated vaccines in the month preceding the inclusion
* Use of chronic oral corticosteroids ≥ 10mg prednisone equivalent a day for a non-COVID-19 related condition
* Patients with baseline Rockwood Clinical Frailty Scale ≥ 6.
* Patients with known hypersensitivity to natural or recombinant Interleukin-7 or to any of the excipients
* Patients under guardianship

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No