Infections

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Symptoms and General Pathology

Blood and Lymph Conditions

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COVID-19

Communicable Diseases

Coronavirus Infections

Lymphopenia

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronaviridae Infections

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Respiratory Tract Diseases

Leukopenia

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Leukocyte Disorders

Syndrome

Immunologic Deficiency Syndromes

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

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

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

CYT107

Same number, volume and frequency of IM administration of saline

Placebo

Steve Pastores, MD

Marcel van den Brink, MD, PhD

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

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

randomized controlled of treatment vs placebo

Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo

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

A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Oncology Cohort

Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety

A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or HospitalDischarge

to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by 11 steps WHO clinical improvement score

The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)

Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45

Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)

Number of days in ICU during index hospitalization

Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)

Number of readmissions to the hospital through Day 45

Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA) through Day 30 or HD

Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30

Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30

Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30

Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )	NCT04426201	COVID-19 Lymphocytopenia	CYT107 Placebo	25 Years - 80 Years	Revimmune
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )	NCT04426201	COVID-19 Lymphocytopenia	CYT107 Placebo	25 Years - 80 Years	Revimmune
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )	NCT04426201	COVID-19 Lymphocytopenia	CYT107 Placebo	25 Years - 80 Years	Revimmune

Spots Global Cancer Trial Database for cyt107

Every month we try and update this database with for cyt107 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cyt107

Every month we try and update this database with for cyt107 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cyt107 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.