Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT04901676
Phase
PHASE3
Status
Suspended

Conditions

  • COVID-19 Pneumonia

Eligibility Criteria

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

Interventions

  • Leronlimab — DRUG
    Leronlimab 700 mg (first dose) followed by weekly 350 mg
  • Placebo — DRUG
    Placebo

Study Details

Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5). Disruption of the C-C chemokine ligand 5 (CCL5)-CCR5 axis via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory leukocytes and dampen pathogenic immune activation in coronavirus disease 2019 (COVID-19). The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in patients hospitalized with COVID-19 pneumonia who are not requiring mechanical ventilation or extracorporeal oxygenation (ECMO).

Key Dates

Start date
Sep 9, 2021
Status verified
May 2021
Primary completion
Jan 31, 2023
Completion
Feb 28, 2023

Study Design

Enrollment
612 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Leronlimab
    Leronlimab subcutaneously once a week (up to 4 doses) until hospital discharge. The first dose will be of 700 mg, followed by weekly doses of 350 mg.
  • Placebo Comparator: Placebo
    Placebo subcutaneously once a week (up to 4 doses) until hospital discharge

Primary Outcome Measure

Cumulative incidence of death or respiratory failure until day 28 [ Time Frame: 28 days ]

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