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

Study summary

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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCYT107 and Placebo

The study team can explain what participation involves.

Who it may be forCOVID-19 · Lymphocytopenia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 11, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

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What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Revimmune

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Revimmune
Interventions being studied: Drug: CYT107; Drug: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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) 4. Patients who received CAR-T cell therapy within the past 1 year (but not within last 30 days- see also

Reasons someone may not be able to joinExclusion criteria

number 6 \& 7) (and/or) 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Memorial sloan ketteringNew York, New York
MD Anderson cancer centerHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 11, 2024. Always confirm current availability with the study team.

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