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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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