Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
Condition: Coronavirus Disease 2019
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Placebo; Leronlimab (700mg)
Intervention description: Placebo; Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Intervention MeSH terms: Leronlimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: COVID-19

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.
    

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

               -  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