Official Title
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Brief Summary

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.

Detailed Description

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. Patients will be

randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab

(PRO 140) and placebo will be administered via subcutaneous injection.



The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.



A total of 75 subjects will be randomized 2:1 in this study.

Active, not recruiting
Coronavirus Disease 2019

Drug: Placebos
Placebo
Placebo

Drug: Leronlimab (700mg)
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
700mg Leronlimab
Other Name: PRO 140

Eligibility Criteria

Inclusion Criteria: 1. Male or female adult ≥ 18 years of age at time of enrollment. 2. Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: Mild (uncomplicated) Illness: - Diagnosed with COVID-19 by a standardized RT-PCR assay AND - Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND - No signs of a more serious lower airway disease AND - RR12); 5. Subjects requiring Renal Replacement Therapy (RRT) at the time of screening; 6. History of severe chronic kidney disease or requiring dialysis; 7. Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation. Note: Subjects infected with HIV-1 will be eligible for the study with undetectable viral load and are on a stable ART regimen. Investigators are required to review the subjects' medical records to confirm HIV-1 RNA suppression within the previous 3 months. Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the course of study. 8. Patients with malignant tumor, or other serious systemic diseases; 9. Patients who are participating in other clinical trials;

10. Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible; and

11. Inability to provide informed consent or to comply with test requirements

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 99 Years
Countries
United States
Locations

University of California, Los Angeles
Los Angeles, California, 90095

Palmtree Clinical Research, Inc.
Palm Springs, California, 92262-4871

Eisenhower Health
Rancho Mirage, California, 92270

Yale
New Haven, Connecticut, 06510

Center for Advanced Research & Education (CARE)
Gainesville, Georgia, 30501

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Atlantic Health System Hospital
Morristown, New Jersey, 07962-1905

Montefiore Medical Center
Bronx, New York, 10467

White Plains Hospital
White Plains, New York, 10601

Novant Health
Charlotte, North Carolina, 27103

Ohio Health
Columbus, Ohio, 43215

Oregon Health and Science University
Portland, Oregon, 97239

CytoDyn, Inc.
NCT Number
Keywords
Covid-19
MeSH Terms
Coronavirus Infections
PRO-140 monoclonal antibody