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Foralumab

In-patient COVID-19 Study of Intranasal Foralumab

Ensayo de Tiziana Life Sciences Ltd en Covid19 · COVID-19 Lower Respiratory Infection · COVID-19 Respiratory Infection (del registro, en inglés).

Más ensayos de: COVID-19.

Fase

Fase 2

Estado

Retirado antes de empezar

Fin del objetivo primario

oct 2022

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en abr 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Withdrawn due to business reasons».

Qué mide

To evaluate the effect of intranasal foralumab on evolution of pulmonary infiltrates in hospitalized subjects with severe COVID-19 pneumonia (Day 14 and Day 28) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 2, randomized, placebo-controlled, double-blind, proof-of-concept study of intranasal foralumab in hospitalized subjects with severe COVID-19 and pulmonary inflammation. Foralumab is a fully human second generation anti-CD3 mAb with a modified Fc unit (two amino acid substitutions) composed of 2 heavy chains with an immunoglobulin (Ig) G1constant region and 2 light chains with a kappa constant region. In a separate Phase 2 randomized, controlled, pilot trial conducted to assess safety, tolerability, and efficacy in 39 patients with mild to moderate COVID-19 in Brazil, showed that intranasal foralumab may be of benefit in modulating immune reactivity and in reducing pulmonary inflammation. Importantly, intranasal administration of foralumab was well tolerated with no clinically significant changes in blood cell counts (including blood lymphocytes), no evidence of hypersensitivity, and no serious adverse events (SAEs) were reported in the study.

Más ensayos de TLSA

Todos los de TLSA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04983446), actualizada en oct 2022.