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Status:

COMPLETED

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

Lead Sponsor:

CytoDyn, Inc.

Conditions:

Coronavirus Disease 2019

Eligibility:

All Genders

18-99 years

Phase:

PHASE2

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 res...

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 res...

Eligibility Criteria

Inclusion

  • Male or female adult ≥ 18 years of age at time of enrollment.
  • 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.

Exclusion

  • Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening;
  • History of severe chronic respiratory disease and requirement for long-term oxygen therapy;
  • Subjects showing signs of clinical jaundice at the time of screening;
  • History of moderate and severe liver disease (Child-Pugh score \>12);
  • Subjects requiring Renal Replacement Therapy (RRT) at the time of screening;
  • History of severe chronic kidney disease or requiring dialysis;
  • 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.
  • Patients with malignant tumor, or other serious systemic diseases;
  • Patients who are participating in other clinical trials;
  • 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
  • Inability to provide informed consent or to comply with test requirements

Key Trial Info

Start Date :

April 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 20 2021

Estimated Enrollment :

86 Patients enrolled

Trial Details

Trial ID

NCT04343651

Start Date

April 1 2020

End Date

September 20 2021

Last Update

January 4 2023

Active Locations (12)

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Page 1 of 3 (12 locations)

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

2

Palmtree Clinical Research, Inc.

Palm Springs, California, United States, 92262-4871

3

Eisenhower Health

Rancho Mirage, California, United States, 92270

4

Yale

New Haven, Connecticut, United States, 06510