Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19

Conditions

• Coronavirus Disease 2019

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebos — DRUG
  Placebos
• 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 is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injections in subjects experiencing prolonged symptoms (\> 12 weeks) of COVID-19.

Key Dates

Start date

Mar 1, 2021

Status verified

Mar 2024

Primary completion

Jun 5, 2021

Completion

Jul 8, 2021

Study Design

Enrollment

56 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

Primary Outcome Measure

Changes From Baseline in Daily COVID-19-related Symptom Severity Score Through Day 56. [ Time Frame: Changes in COVID-19 related symptoms from baseline (start of treatment) and day 56 (end of treatment) ]

Locations (2)

Find similar trials in Aventura, FL

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