InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK Cohort

NCT ID: NCT04379076

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-14
• Study Completion Date: 2022-03-30

Brief 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.

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 will take place after the first 12 patients. If the CYT107 is well tolerated, the test dose (3 μg/kg) will cease and that initial dose will become 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

Conditions

COVID-19; Lymphocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CYT107

Intra-muscular administration of CYT107 twice a week for a total of 5 administrations

Group Type: EXPERIMENTAL

Interleukin-7

Intervention Type: DRUG

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

Saline

Intramuscular (IM) administration of saline at the same volume and same time for a total of 5 administrations

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

Interleukin-7

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

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Other Intervention Names

CYT107; Saline

Eligibility Criteria

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
• 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 >2L 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
• Private insurance or government support (through NHS or other)

Exclusion Criteria

• 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.
• Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
• Patients whose respiratory condition is showing significant deterioration as indicated by:
• requirement for a persistent and sustained increase in inspired oxygen concentrations of 20% or more over the past 24 hours to maintain SpO2 at greater than or equal to 88% (this 20 % limit does not apply to O2 delivered by nasal canula)
• or need for invasive mechanical ventilation
• Patients with chronic kidney dialysis
• 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 a SOFA score ≥ 9 at baseline
• Patients with a BMI > 40
• Patients with baseline Rockwood Clinical Frailty Scale ≥ 6.(assessed as patient or proxy 4-week recall of chronic health and frailty status prior to COVID infection)
• Patients under guardianship

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amarex Clinical Research

OTHER

Sponsor Role: collaborator

Revimmune

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manu Shankar-Hari, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

Sandwell Birmingham Hospital

Birmingham, , United Kingdom

Sandwell Birmingham Hospital

Birmingham, , United Kingdom

Bradford Institute for Health Research

Bradford, , United Kingdom

ST JAMES's UNIVERSITY HOSPITAL

Leeds, , United Kingdom

Medway Maritime Hospital

London, , United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

King'S College Hospital

London, , United Kingdom

Wythenshawe Hospital/ Manchester Royal Infirmary

Manchester, , United Kingdom

North Manchester General Hospital

Manchester, , United Kingdom

Royal Victoria Infirmary and Freeman Hospital

Newcastle, , United Kingdom

Royal Preston Hospital

Preston, , United Kingdom

Sunderland Royal Hospital

Sunderland, , United Kingdom

Watford General Hospital

Watford, , United Kingdom

Countries

United Kingdom

References

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Other Identifiers

CLI107 COVID UK (ILIAD-7-UK)

Identifier Type: -

Identifier Source: org_study_id