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

NCT04426201 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: ILIAD-7 COVID US ONCO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

COVID-19; Lymphocytopenia

Outcome Measures

Primary Outcomes (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

  one month

Secondary Outcomes (14)

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

  one month

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

  1 month or HD (whichever occurs first)

• frequency of secondary infections through day 45 compared to placebo arm

  45 days

• length of hospitalization compared to placebo arm

  45 days

• length of stay in ICU compared to placebo arm

  45 days

Other Outcomes (1)

• Safety assessment through incidence and scoring of grade 3-4 adverse events

  45 days

Study Arms (2)

CYT107 Treatment

EXPERIMENTAL

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

Drug: CYT107

Saline control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CYT107 DRUG

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

Also known as: Interleukin-7

CYT107 Treatment

Placebo DRUG

Same number, volume and frequency of IM administration of saline

Also known as: Saline

Saline control

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Revimmune: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• Amarex Clinical Research: collaborator
• M.D. Anderson Cancer Center: collaborator
• Cancer Research Institute, New York City: collaborator

Study Sites (2)

Memorial sloan kettering

New York, New York, 10065, United States

Location

MD Anderson cancer center

Houston, Texas, 77030, United States

Location

Related Publications (5)

• 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.

  PMID: 32171076 RESULT

• 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.

  PMID: 32031570 RESULT

• 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.

  PMID: 29515037 RESULT

• 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.

  PMID: 23053510 RESULT

• 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.

  PMID: 39903535 DERIVED

MeSH Terms

Conditions

COVID-19; Lymphopenia

Interventions

Interleukin-7; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Steve Pastores, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Marcel van den Brink, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized controlled of treatment vs placebo

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: December 20, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)