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History of Changes for Study: NCT04347239
Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
Latest version (submitted July 30, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 14, 2020 None (earliest Version on record)
2 April 29, 2020 Study Status
3 May 4, 2020 Eligibility and Study Status
4 May 7, 2020 Contacts/Locations and Study Status
5 May 8, 2020 Contacts/Locations and Study Status
6 June 1, 2020 Contacts/Locations and Study Status
7 June 10, 2020 Contacts/Locations, Eligibility and Study Status
8 August 10, 2020 Study Status and Contacts/Locations
9 August 19, 2020 Contacts/Locations and Study Status
10 August 28, 2020 Contacts/Locations and Study Status
11 October 14, 2020 Contacts/Locations and Study Status
12 November 13, 2020 Contacts/Locations and Study Status
13 March 18, 2021 Study Status, Contacts/Locations, Study Design and Study Description
14 April 13, 2021 Contacts/Locations and Study Status
15 July 30, 2021 Recruitment Status, Study Status and Contacts/Locations
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Study NCT04347239
Submitted Date:  August 19, 2020 (v9)

Open or close this module Study Identification
Unique Protocol ID: CD12_COVID-19
Brief Title: Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
Official Title: A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2020
Overall Status: Recruiting
Study Start: April 15, 2020
Primary Completion: December 31, 2020 [Anticipated]
Study Completion: April 1, 2021 [Anticipated]
First Submitted: April 13, 2020
First Submitted that
Met QC Criteria:
April 14, 2020
First Posted: April 15, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
August 19, 2020
Last Update Posted: August 20, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: CytoDyn, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.
Detailed Description:

This is a Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical 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.

Open or close this module Conditions
Conditions: Coronavirus Disease 2019
Keywords: COVID-19
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 390 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebos
Placebos
Experimental: 700mg Leronlimab Drug: Leronlimab (700mg)
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. All-cause mortality at Day 28
[ Time Frame: Day 28 ]

Day 0 refers to the data of randomization/first treatment.
Secondary Outcome Measures:
1. All-cause mortality at Day 14
[ Time Frame: Day 14 ]

Day 0 refers to the data of randomization/first treatment.
2. Change in clinical status of subject at Day 14 (on a 7 point ordinal scale)
[ Time Frame: Day 14 ]

A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
3. Change in clinical status of subject at Day 28 (on a 7 point ordinal scale)
[ Time Frame: Day 28 ]

A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
4. Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
[ Time Frame: Day 14 ]

The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Male or female adult ≥ 18 years of age at time of screening.
  2. Subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below:

    A. Severe Illness:

    - Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing within 5 days of screening

    AND

    Symptoms of severe systemic illness/infection with COVID-19:

    - At least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress

    AND

    Clinical signs indicative of severe systemic illness/infection with COVID-19, with at least 1 of the following:

    - RR ≥ 30, HR ≥ 125, SaO2 <93% on room air or requires > 2L oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2 <300

    AND

    - None of the following: Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations), Septic shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg), Multiple organ dysfunction/failure

    B. Critical Illness:

    - Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing within 5 days of screening

    AND

    Evidence of critical illness, defined by at least 1 of the following:

    - Respiratory failure defined based on resource utilization requiring at least 1 of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (in setting of resource limitation)

    OR

    - Shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg or requiring vasopressors)

    OR

    -Multiple organ dysfunction/failure

  3. Subject, if intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg.
  4. Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator
  5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  6. Understands and agrees to comply with planned study procedures.
  7. Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.

Exclusion Criteria:

  1. Subjects with do-not-resuscitate (DNR) and/or do-not-intubate (DNI) orders or expected to be made DNR/DNI in setting of resource limitations or family wishes.
  2. Not a candidate for dialysis or continuation of care (or full medical support) in setting of resource limitations.
  3. Subject on continuous vasopressors (at the dose of norepinephrine >20μg/min and/or vasopressin >0.04 units/kg/min) for >48 hours at time of screening.
  4. Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.
  5. Inability to provide informed consent or to comply with test requirements
  6. Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment
  7. Pregnancy or breast feeding
  8. Subject participating in another study with for an investigational treatment for COVID-19.

Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care.

Open or close this module Contacts/Locations
Central Contact Person: Kush Dhody, MBBS, MS, CCRA
Telephone: 301-956-2536
Email: kushd@amarexcro.com
Locations: United States, California
UCLA
[Recruiting]
Los Angeles, California, United States, 90095
Contact:Contact: Nancy Lopez 310-794-8043 NancyRLopez@mednet.ucla.edu
Contact:Principal Investigator: Otto Yang, MD
Eisenhower Health
[Not yet recruiting]
Rancho Mirage, California, United States, 92270
Contact:Principal Investigator: Shahriyar Tavakoli, MD
United States, Connecticut
Yale
[Not yet recruiting]
New Haven, Connecticut, United States, 06510
Contact:Principal Investigator: Onyema Ogbuagu, MD
United States, Massachusetts
Beth Israel Deaconess Medical Center
[Recruiting]
Boston, Massachusetts, United States, 02215
Contact:Contact: Caitlin Davis 617-735-4466 Cdavis6@bidmc.harvard.edu
Contact:Principal Investigator: Sabrina Tan, MD
United States, New Jersey
St. Barnabas
[Recruiting]
Livingston, New Jersey, United States, 07052
Contact:Principal Investigator: Subroto Paul, MD
Atlantic Health System Hospital
[Recruiting]
Morristown, New Jersey, United States, 07962-1905
Contact:Principal Investigator: Eric Whitman, MD
United States, New York
Montefiore Medical Center
[Recruiting]
Bronx, New York, United States, 10467
Contact:Contact: Jane Wilson 718-920-7916
Contact:Principal Investigator: Harish Seethamraju, MD
United States, North Carolina
Novant Health
[Recruiting]
Winston-Salem, North Carolina, United States, 27103
Contact:Contact: Kathleen O'Brien kathleen.obrien@novanthealth.org
Contact:Contact: Pailing Richards 704-996-7627 pcrichards@novanthealth.org
Contact:Principal Investigator: Michael Morgan, MD
United States, Ohio
Ohio Health
[Recruiting]
Columbus, Ohio, United States, 43215
Contact:Principal Investigator: Kiran Devulapally, MD
United States, Oregon
Oregon Health and Sciences University
[Not yet recruiting]
Portland, Oregon, United States, 97239
Contact:Principal Investigator: Marcel Curlin, MD
United States, Texas
Baylor Scott & White research Institute
[Recruiting]
Dallas, Texas, United States, 75204
Contact:Contact: Samantha Wang 214-818-2526 Samantha.wang@bswhealth.org
Contact:Principal Investigator: Uriel Uriel Sandkovsky
University of Texas
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Jordan Lake 713-500-6767 Jordan.e.lake@uth.tmc.edu
Contact:Principal Investigator: Jordan Lake, MD
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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