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COVID-19Phase 2ILIAD-7-FRNCT04407689

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

A Phase 2 study testing Interleukin-7 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 6 sites in France.

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 two 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?
Interleukin-7
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
6 sitesFrance
Study dates
8 Jun 2020to 30 Mar 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
  • 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
  • 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) for respiratory failure
  • Confirmed infection with COVID-19 by any acceptable test available/ utilized at each site
  • Patient with medical insurance or government support

Who cannot join

  • 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.
Show all 22Show fewer
  • Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
  • Patients whose respiratory condition is showing significant deterioration as indicated by:
  • 8a requirement for an increase in inspired oxygen concentrations of 20% or more over the past 24 hours to maintain SpO2 at greater than or equal to 88%
  • 8b or need for invasive mechanical ventilation
  • 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 chronic kidney dialysis
  • Patients with a SOFA score ≥ 9 at baseline
  • Patients with a BMI > 40
  • Patients receiving any agent with immune suppressive effects,such as 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • University Hospital of Limoges

    Limoges, 87042

  • Hôpital Edouard Herriot

    Lyon, 69003

  • hopital Edouard Herriot

    Lyon, 69437

  • Chr Orleans La Source

    Orléans, 45067

  • hopital COCHIN

    Paris, 75014

  • Chru Tours

    Tours, 37000

Other trials in France

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 in France and Belgium

Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/ kg twice a week for two 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 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safety review took place after the first 12 patients. Since the CYT107 was well tolerated, the test dose (3 μg/kg) ceased and the initial dose became the same as the rest of the doses (10 μg/kg). So, the remaining patients will be randomized to receive 5 administrations of (a) CYT107 at 10 μg/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

Being tested
Interleukin-7, 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.

  • Interleukin-7Drug

    Also called CYT107

    Intramuscular (IM) administration of CYT107 at 3 μg/ kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or

  • PlaceboDrug

    Also called Saline

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

Study groups in NCT04407689
Study groupRoleWhat they receive
CYT107ExperimentalIntra-muscular administration of CYT107 twice a week for a total of 5 administrations
Receives: Drug: Interleukin-7
SalinePlacebo comparatorIntramuscular (IM) administration of saline at the same volume and same time for a total of 5 administrations
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 Hospital Discharge

    Measured: 1 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: 1 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 tp 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 timepoints 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 posted29 May 2020
  2. Study start8 Jun 2020
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407689
Sponsor's protocol ID
CLI107 COVID FR (ILIAD-7-FR)
Acronym
ILIAD-7-FR
Status last verified
Mar 2022
First submitted
27 May 2020
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: publication

Publications

  • 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

  • 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

  • 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 Interleukin-7 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 6 sites in France.

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 6 inclusion and 22 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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: 1 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 NCT04407689, 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 8 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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