Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19

Conditions

• Coronavirus Disease 2019

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo
• Leronlimab (700mg) — DRUG
  Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Study Details

The purpose of this study was assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.

Key Dates

Start date

Apr 16, 2020

Status verified

Sep 2025

Primary completion

Oct 24, 2021

Completion

Jun 15, 2022

Study Design

Enrollment

484 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Syringes containing normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
• Experimental: 700mg Leronlimab
  Each vial of active contains 350mg of leronlimab at a concentration of 175mg/ml (nominal 2mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.
• Experimental: 700mg Leronlimab Open Label
  Each vial of active contains 350mg of leronlimab at a concentration of 175mg/ml (nominal 2mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.

Primary Outcome Measure

All-cause Mortality at Day 28 [ Time Frame: Mortality at day 28 (Visit 2, start of treatment = day 0) ]

Locations (18)

Find similar trials in Alexander City, AL

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