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.
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.
Drug: Placebo
Placebo
Drug: Leronlimab (700mg)
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Other Name: PRO 140
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
- 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
3. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered
not clinically significant by the Principal Investigator.
4. Subject (or legally authorized representative) provides written informed consent prior
to initiation of any study procedures.
5. Understands and agrees to comply with planned study procedures.
6. 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 Criteria:
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.
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
University of California, Los Angeles
Los Angeles, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
Eisenhower Health
Rancho Mirage, California, United States
Yale
New Haven, Connecticut, United States
Center for Advanced Research & Education (CARE)
Gainesville, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Atlantic Health System Hospital
Morristown, New Jersey, United States
Montefiore Medical Center
Bronx, New York, United States
White Plains Hospital
White Plains, New York, United States
Novant Health
Charlotte, North Carolina, United States
Ohio Health
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Angela Ritter, MD, Principal Investigator
Center for Advanced Research and Education