NCT04983446

In-patient COVID-19 Study of Intranasal Foralumab

A Phase 2 Proof-of-concept Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Foralumab in Hospitalized Subjects With Severe COVID-19 and Pulmonary Inflammation

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tiziana Life Sciences LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 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.

Detailed description

Approximately 80 hospitalized subjects with severe COVID-19 and evidence of pulmonary involvement on a computed tomography (CT) scan at screening will be enrolled in this study over 4 months, depending on enrollment. Up to 7 centers in Brazil will conduct this study. The main study objective is to evaluate the effect of intranasal foralumab on evolution of pulmonary infiltrates in hospitalized subjects with severe COVID-19 pneumonia. Subjects will be randomized 1:1 to receive intranasal foralumab 100 µg (50 µg in 0.1 ml solution into each nostril) or placebo (0.1 ml vehicle solution into each nostril). All subjects will receive continued Standard of Care (SoC) therapy (per hospital/study site policies and guidelines) together with intranasal foralumab or placebo for the entire 14-day treatment period. Subjects will participate in the study approximately 35 days (from screening to completion).

Conditions

• Covid19
• COVID-19 Lower Respiratory Infection
• COVID-19 Respiratory Infection

Interventions

Type	Name	Description
DRUG	Foralumab	Foralumab is a second generation fully human anti-CD3 antibody
OTHER	Placebo	Placebo will be the vehicle for the foralumab nasal solution without active drug (25 mM sodium acetate/125 mM sodium chloride/0.02% polysorbate 80, pH 5.5 buffer).

Timeline

• Start date: 2022-04-30
• Primary completion: 2022-10-30
• Completion: 2022-12-30
• First posted: 2021-07-30
• Last updated: 2022-10-19