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

NCT04678830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-04-11

Study results available
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Summary

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.

Conditions

  • Coronavirus Disease 2019

Interventions

DRUG

Placebos

Placebos

DRUG

Leronlimab (700mg)

Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Norman Gaylis, MD · Arthritis and Rheumatic Disease Specialties Aventura Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-06-05
Completion
2021-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678830 on ClinicalTrials.gov