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TERMINATEDPHASE2

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

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 UK

NCT04379076•Revimmune

View on ClinicalTrials.gov

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

Eligibility

Age

25 - 80 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (13)

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

Key Dates

Start Date

May 14, 2020

Primary Completion Date

February 28, 2022

Completion Date

March 30, 2022

Last Updated

April 7, 2022

Enrollment

ACTUAL participants

Conditions

COVID-19Lymphocytopenia

Interventions

Interleukin-7

DRUG

Placebos

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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