In-patient COVID-19 Study of Intranasal Foralumab

Sponsor
Tiziana Life Sciences LTD
Study ID
NCT04983446
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Foralumab — DRUG
    Foralumab is a second generation fully human anti-CD3 antibody
  • Placebo — OTHER
    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).

Study Details

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.

Key Dates

Start date
Apr 30, 2022
Status verified
Oct 2022
Primary completion
Oct 30, 2022
Completion
Dec 30, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Foralumab Arm + Standard of Care
    Subjects in this arm would receive, intranasal foralumab 100 µg (50 µg in 0.1 ml solution into each nostril).
  • Active Comparator: Placebo Arm + Standard of Care
    Subjects in this arm would receive, placebo (0.1 ml vehicle solution into each nostril).

Primary Outcome Measure

To evaluate the effect of intranasal foralumab on evolution of pulmonary infiltrates in hospitalized subjects with severe COVID-19 pneumonia [ Time Frame: Day 14 and Day 28 ]

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