NCT04426201

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Revimmune · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• COVID-19
• Lymphocytopenia

Interventions

Type	Name	Description
DRUG	CYT107	IM administration at 10µg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
DRUG	Placebo	Same number, volume and frequency of IM administration of saline

Timeline

• Start date: 2020-12-20
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-06-11
• Last updated: 2024-04-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study