Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19

Conditions

• Coronavirus Disease 2019

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

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

This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.

Key Dates

Start date

Apr 1, 2020

Status verified

Dec 2022

Primary completion

Jul 21, 2020

Completion

Sep 20, 2021

Study Design

Enrollment

86 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.
• Experimental: 700mg Leronlimab
  Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.

Primary Outcome Measure

Mean Change From Baseline in Total Symptom Score [ Time Frame: Clinical Improvement will be assessed at baseline and at EOT (day 14). ]

Locations (12)

Find similar trials in Los Angeles, CA

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