Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT04901689
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
  • 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 critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation (ECMO).

Key Dates

Start date
Oct 23, 2021
Status verified
May 2021
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023

Study Design

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

Arms

  • Experimental: Leronlimab (700 mg)
    Leronlimab 700 mg intravenously once a week (up to 4 doses) until hospital discharge
  • Placebo Comparator: Placebo
    Placebo intravenously once a week (up to 4 doses) until hospital discharge

Primary Outcome Measure

Cumulative proportion of clinical recovery [ Time Frame: 28 days ]

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