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COVID-19Phase 2ILIAD-7-US-ONCT04426201

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

A Phase 2 study testing CYT107 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 25 to 80 years
Conditions the study is for
COVID-19, Lymphocytopenia
What is being tested?
CYT107
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
2 sitesUnited States
Study dates
20 Dec 2020to 30 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • MD Anderson cancer center

    Houston, Texas, 77030

  • Memorial sloan kettering

    New York, New York, 10065

Other trials in United States

About this study

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

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

Read the detailed description

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

Being tested
CYT107, Placebo
Medical subject headings
COVID-19, Lymphopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CYT107Drug

    Also called Interleukin-7

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

  • PlaceboDrug

    Also called Saline

    Same number, volume and frequency of IM administration of saline

Study groups in NCT04426201
Study groupRoleWhat they receive
CYT107 TreatmentExperimentalIntramuscular (IM) administration of CYT107 twice a week for 3 weeks
Receives: Drug: CYT107
Saline controlPlacebo comparatorIntramuscular (IM) placebo (normal saline) at the same frequency
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

    Measured: one month

Secondary outcomes (14)

  1. To obtain "clinical improvement" as defined by an improvement in a 11-points WHO score for Clinical Assessment, through day 30 or HD.

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

    Measured: one month

  2. a significant decline of SARS-CoV-2 viral load through day 30 or HD

    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)

    Measured: 1 month or HD (whichever occurs first)

  3. frequency of secondary infections through day 45 compared to placebo arm

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

    Measured: 45 days

  4. length of hospitalization compared to placebo arm

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

    Measured: 45 days

  5. length of stay in ICU compared to placebo arm

    Number of days in ICU during index hospitalization

    Measured: 45 days

  6. number of readmissions to ICU compared to placebo arm

    Readmissions to ICU through Day 45

    Measured: 45 days

  7. organ support free days compared to placebo arm

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

    Measured: 45 days

  8. Frequency of re-hospitalization through day 45 compared to placebo arm

    Number of readmissions to the hospital through Day 45

    Measured: 45 days

  9. All-cause mortality through day 45 compared to placebo arm

    All-cause mortality through Day 45

    Measured: 45 days

  10. CD4+ and CD8+ T cell counts compared to placebo arm

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

    Measured: 30 days

  11. level of other known biomarkers of inflammation: Ferritin compared to placebo arm

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

    Measured: 30 days

  12. Level of other known biomarkers of inflammation: CRP compared to placebo arm

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

    Measured: 30 days

  13. Level of other known biomarkers of inflammation: D-dimer compared to placebo arm

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

    Measured: 30 days

  14. Physiological status through NEWS2 evaluation compared to Placebo arm

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start20 Dec 2020
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Why it stopped: POOR ACCRUAL

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled of treatment vs placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04426201
Sponsor's protocol ID
ILIAD-7 COVID US ONCO
Acronym
ILIAD-7-US-O
Status last verified
Apr 2024
First submitted
9 Jun 2020
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Publication

Publications

  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

    PubMed 32171076

  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PubMed 32031570

  • Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmele T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5):e98960. doi: 10.1172/jci.insight.98960.

    PubMed 29515037

  • Venet F, Foray AP, Villars-Mechin A, Malcus C, Poitevin-Later F, Lepape A, Monneret G. IL-7 restores lymphocyte functions in septic patients. J Immunol. 2012 Nov 15;189(10):5073-81. doi: 10.4049/jimmunol.1202062. Epub 2012 Oct 10.

    PubMed 23053510

  • Shankar-Hari M, Francois B, Remy KE, Gutierrez C, Pastores S, Daix T, Jeannet R, Blood J, Walton AH, Salomao R, Auzinger G, Striker D, Martin RS, Anand NJ, Bosanquet J, Blood T, Brakenridge S, Moldawer LL, Vachharajani V, Yee C, Dal-Pizzol F, Morre M, Berbille F, van den Brink M, Hotchkiss R. A randomized, double-blind, placebo-controlled trial of IL-7 in critically ill patients with COVID-19. JCI Insight. 2025 Feb 4;10(6):e189150. doi: 10.1172/jci.insight.189150.

    PubMed 39903535

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CYT107 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: POOR ACCRUAL). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04426201, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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