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

STATUS

Recruiting
participants needed

48
sponsor

Revimmune

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Updated on 19 February 2024

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corticosteroids

prednisone

intermittent positive pressure ventilation

covid-19

interleukins

respiratory failure

invasive positive pressure ventilation

absolute lymphocyte count

interleukin-7

Summary

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

Description

Approximately forty-eight (48) participants will be randomized 1:1 to receive (a) Intramuscular (IM) administration of CYT107 at 3 g/kg followed, after 48hrs of observation, by 10 g/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safety review will take place after the first 12 patients. If the CYT107 is well tolerated, the test dose (3 g/kg) will cease and that initial dose will become the same as the rest of the doses (10 g/kg). So, the remaining patients will be randomized to receive 5 administrations of (a) CYT107 at 10 g/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

Details

Condition	Lymphopenia, Covid 19
Age	25-80 years
Treatment	Placebo, Interleukin-7
Clinical Study Identifier	NCT04407689
Sponsor	Revimmune
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 two absolute lymphocyte count (ALC) 1000 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)
	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
	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
	Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours
	Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300 mg/day and/or 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

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