InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O ) (ILIAD-7-US-O)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04426201 |
Recruitment Status :
Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : April 8, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 Lymphocytopenia | Drug: CYT107 Drug: Placebo | Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | randomized controlled of treatment vs placebo |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 20, 2020 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: CYT107 Treatment
Intramuscular (IM) administration of CYT107 twice a week for 3 weeks
|
Drug: CYT107
IM administration at 10µg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
Other Name: Interleukin-7 |
Placebo Comparator: Saline control
Intramuscular (IM) placebo (normal saline) at the same frequency
|
Drug: Placebo
Same number, volume and frequency of IM administration of saline
Other Name: Saline |
- Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first [ Time Frame: one month ]A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or HospitalDischarge
- To obtain "clinical improvement" as defined by an improvement in a 11-points WHO score for Clinical Assessment, through day 30 or HD. [ Time Frame: one month ]to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by 11 steps WHO clinical improvement score
- a significant decline of SARS-CoV-2 viral load through day 30 or HD [ Time Frame: 1 month or HD (whichever occurs first) ]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)
- frequency of secondary infections through day 45 compared to placebo arm [ Time Frame: 45 days ]Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
- length of hospitalization compared to placebo arm [ Time Frame: 45 days ]Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
- length of stay in ICU compared to placebo arm [ Time Frame: 45 days ]Number of days in ICU during index hospitalization
- number of readmissions to ICU compared to placebo arm [ Time Frame: 45 days ]Readmissions to ICU through Day 45
- organ support free days compared to placebo arm [ Time Frame: 45 days ]Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)
- Frequency of re-hospitalization through day 45 compared to placebo arm [ Time Frame: 45 days ]Number of readmissions to the hospital through Day 45
- All-cause mortality through day 45 compared to placebo arm [ Time Frame: 45 days ]All-cause mortality through Day 45
- CD4+ and CD8+ T cell counts compared to placebo arm [ Time Frame: 30 days ]Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA) through Day 30 or HD
- level of other known biomarkers of inflammation: Ferritin compared to placebo arm [ Time Frame: 30 days ]Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
- Level of other known biomarkers of inflammation: CRP compared to placebo arm [ Time Frame: 30 days ]Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
- Level of other known biomarkers of inflammation: D-dimer compared to placebo arm [ Time Frame: 30 days ]Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
- Physiological status through NEWS2 evaluation compared to Placebo arm [ Time Frame: 30 days ]Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
- Safety assessment through incidence and scoring of grade 3-4 adverse events [ Time Frame: 45 days ]Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- Patient receiving active or recent chemotherapy or immunotherapy (within 6 months) for cancer (and/or)
- Patients who have received hematopoietic stem cell transplantation (for a diagnosis other than lymphoma) within the past 1 year (and/or)
- Patients who received CAR-T cell therapy within the past 1 year (but not within last 30 days- see also exclusion criteria number 6 & 7) (and/or)
- Patients receiving hormonal therapy for cancer (and/or)
- Patients who have undergone surgery or radiotherapy for cancer within the past 6 months
- Patients with newly diagnosed (biopsy proven) malignancy who have not yet received cancer treatment but get COVID pneumonia in the interim (Incl. Criteria 11)
- 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 .
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
- Willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure
Exclusion Criteria:
- Pregnancy or breast feeding;
- ALT and/or AST > 5 x ULN
- Known, active auto-immune disease;
- Patients with a history of lymphoid malignancy
- Patients with any malignancy that is present at time of enrollment where treating physician expects life expectancy due to the underlying malignancy to be less than 6 months
- Patients who received CAR-T cell therapy within the past 30 days or with unresolved cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS)
- Patients with unresolved grade > 2 toxicities from prior chemotherapy, immunotherapy, or CAR-T cell therapy
- 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 with a mechanical ventilation support ≥ 7 days
- Patients with chronic kidney dialysis
- Patients with a SOFA score ≥ 9 at baseline
- Patients with a BMI > 40
- 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 hospital admission Rockwood Clinical Frailty Scale ≥ 6. (assessed as patient or proxy 4-week recall of chronic health and frailty status prior to COVID infection)
11. Patients under guardianship

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04426201
United States, New York | |
Memorial sloan kettering | |
New York, New York, United States, 10065 | |
United States, Texas | |
MD Anderson cancer center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Steve Pastores, MD | Memorial Sloan Kettering Cancer Center | |
Principal Investigator: | Marcel van den Brink, MD, PhD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Revimmune |
ClinicalTrials.gov Identifier: | NCT04426201 |
Other Study ID Numbers: |
ILIAD-7 COVID US ONCO |
First Posted: | June 11, 2020 Key Record Dates |
Last Update Posted: | April 8, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Publication |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Lymphopenia Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Leukopenia Leukocyte Disorders Hematologic Diseases Immunologic Deficiency Syndromes Immune System Diseases |