The trial of InterLeukin-7 in lymphopenic patients With COVID-19

Revimmune is recruiting patients for the clinical trial of InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection (Brazil Cohort) (ILIAD-7 BRA).

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.

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 7administrations 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 excludes oncology patients on treatment

Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo.

The researchers plan that March 1, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in June 30, 2022.

Among primary outcome measures are the 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 and A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge.

The study will take place at the Hospital de Clinicas de Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil; Hospital Sao Jose, São José, Santa Catarina, Brazil; Upeclin-Unesp, Botucatu, SAO Paolo, Brazil; Hospital Das Clinicas de Ribeirao Preto, Monte Alegre, SAO Paolo, Brazil; Universidade Federal de Sao Paolo, São Paulo, SAO Paolo, Brazil; Hospital Edmundo Vasconcelos, Vila Clementino, SAO Paolo, Brazil.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04927169.

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