Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
Otto Yang, MD (ucla)

Description

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.

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)

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. 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.

Keywords

Coronavirus Disease 2019 COVID-19 Coronavirus Infections PRO-140 monoclonal antibody Leronlimab (700mg)

Eligibility

You can join if…

Open to people ages 18-99

  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
  • RR<20, HR <90, oxygen saturation (pulse oximetry) > 93% on room air

Moderate Illness:

  • Diagnosed with COVID-19 by a standardized RT-PCR assay AND
  • In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
  • Signs of moderate pneumonia, including RR ≥ 20 but <30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) > 93% on room air AND
  • If available, lung infiltrates based on X-ray or CT scan < 50% present
  • Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
  • Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  • Understands and agrees to comply with planned study procedures.
  • Women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices) for the duration of the study.

You CAN'T join if...

  1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening;
  2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy;
  3. Subjects showing signs of clinical jaundice at the time of screening;
  4. History of moderate and severe liver disease (Child-Pugh score >12);
  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.

  1. Patients with malignant tumor, or other serious systemic diseases;
  2. Patients who are participating in other clinical trials;
  3. . 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
  4. . Inability to provide informed consent or to comply with test requirements

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Palmtree Clinical Research, Inc. accepting new patients
    Palm Springs California 92262-4871 United States
  • Eisenhower Health accepting new patients
    Rancho Mirage California 92270 United States

Lead Scientist at UC Health

  • Otto Yang, MD (ucla)
    Professor, Medicine. Authored (or co-authored) 153 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CytoDyn, Inc.
ID
NCT04343651
Phase
Phase 2
Study Type
Interventional
Last Updated