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A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Trial Profile

A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Jun 2020

At a glance

  • Drugs Leronlimab (Primary)
  • Indications COVID 2019 infections
  • Focus Proof of concept; Therapeutic Use
  • Sponsors CytoDyn
  • Most Recent Events

    • 22 May 2020 According to a CytoDyn media release, the company will hold conference call to provide updates on COVID-19 (Phase 2, 3 & eIND) on Tuesday, May 26, 2020.
    • 21 May 2020 According a Montefiore media release, this trial is conducted under the direction of the departments of cardiothoracic surgery and medicine at Montefiore Health System and Albert Einstein College of Medicine.
    • 19 May 2020 According a CytoDyn media release, the company anticipates results of this trial along with a planned trial in Mexico, could establish a path for quick approval in Mexico for use of leronlimab in COVID-19 patients.

Trial Overview

Purpose

This Phase 2, two-arm, placebo controlled study is designed 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.

Primary Endpoints

Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough)

description: Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
time_frame: Day 14

Other Endpoints

Time to clinical resolution (TTCR)

time_frame: Day 14

Change from baseline in National Early Warning Score 2 (NEWS2)

description: This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.
time_frame: Days 3, 7, and 14

Change from baseline in pulse oxygen saturation (SpO2)

time_frame: Days 3, 7, and 14

Change from baseline in the patient's health status on a 7-category ordinal scale

description: 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.
Lower scores mean a worse outcome.
time_frame: Days 3, 7, and 14

Incidence of hospitalization

time_frame: Day 14

Duration (days) of hospitalization

time_frame: Day 14

Incidence of mechanical ventilation supply

time_frame: Day 14

Duration (days) of mechanical ventilation supply

time_frame: Day 14

Incidence of oxygen use

time_frame: Day 14

Duration (days) of oxygen use

time_frame: Day 14

Mortality rate

time_frame: Day 14

Time to return to normal activity

time_frame: Day 14

Change in size of lesion area by chest radiograph or CT

time_frame: Day 14

Change from baseline in serum cytokine and chemokine levels

time_frame: Days 3, 7, and 14

Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages

time_frame: Days 3, 7, and 14

Change from baseline in CD3+, CD4+ and CD8+ T cell count

time_frame: Days 3, 7, and 14 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 75

  • Sex male & female
  • Age Group 18-99 years; adult; elderly

Patient 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.

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04343651 ClinicalTrials.gov: US National Institutes of Health
CD10COVID19 -

Organisations

  • Sponsors CytoDyn
  • Affiliations CytoDyn

Trial Dates

  • Initiation Dates

    Actual : 01 Apr 2020

  • Primary Completion Dates

    Planned : 04 Dec 2020

  • End Dates

    Planned : 04 Apr 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location USA
  • Focus Proof of concept; Therapeutic Use

Interventions

Drugs Route Formulation
LeronlimabPrimary Drug Subcutaneous Injection

Placebo

Drug: Placebos (Placebo)

700mg Leronlimab

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

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Eric Whitman, MD Atlantic Health System Hospital USA
Harish Seethamraju, MD Montefiore Medical Center USA
Kenneth Lichenstein, MD Eisenhower Health USA
Kiran Devulapally, MD Ohio Health USA
Kush Dhody, MBBS, MS, CCRA
301-956-2536 kushd@amarexcro.com
show details
-
Marcel Curlin, MD Oregon Health and Science University USA
Michael Morgan, MD Novant Health USA
Nancy Lopez
310-794-8043 NancyRLopez@mednet.ucla.edu
show details
University of California, Los Angeles USA
Onyema Ogbuagu, MD Yale USA
Otto Yang, MD University of California, Los Angeles USA
Pam Philippsborn
718-920-5864
show details
Montefiore Medical Center USA
Richard Loftus, MD Palmtree Clinical Research, Inc. USA
Richards Richards
704-996-7627 pcrichards@novanthealth.org
show details
Novant Health USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Atlantic Health System Hospital Morristown, New Jersey USA
CytoDyn
-
-
Eisenhower Health Rancho Mirage, California USA
Montefiore Medical Center Bronx, New York USA
Novant Health Charlotte, North Carolina USA
Ohio Health Columbus, Ohio USA
Oregon Health and Science University Portland, Oregon USA
Palmtree Clinical Research, Inc. Palm Springs, California USA
University of California, Los Angeles Los Angeles, California USA
Yale New Haven, Connecticut USA

Trial History

Event Date Event Type Comment
05 Jun 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 05 Jun 2020
22 May 2020 Other trial event According to a CytoDyn media release, the company will hold conference call to provide updates on COVID-19 (Phase 2, 3 & eIND) on Tuesday, May 26, 2020. Updated 26 May 2020
21 May 2020 Other trial event According a Montefiore media release, this trial is conducted under the direction of the departments of cardiothoracic surgery and medicine at Montefiore Health System and Albert Einstein College of Medicine. Updated 24 May 2020
19 May 2020 Other trial event According a CytoDyn media release, the company anticipates results of this trial along with a planned trial in Mexico, could establish a path for quick approval in Mexico for use of leronlimab in COVID-19 patients. Updated 24 May 2020
05 May 2020 Other trial event According to an Ajinomoto Bio-Pharma Services, the company has entered into a manufacturing services agreement with CytoDyn Inc., for the supply of the investigational new drug, leronlimab (PRO 140), which is currently being used in clinical trial protocols for Mild-to-Moderately Ill (NCT04343651) and Severely Ill (NCT04347239) COVID-19 patients. Updated 06 May 2020
04 May 2020 Other trial event According to a CytoDyn media release, the company expects to complete enrollment of 75 patients by the end of May. Updated 06 May 2020
29 Apr 2020 Other trial event According to a CytoDyn media release, Dr. Nader Pourhassan, will provide a comprehensive update on leronlimab for COVID-19. The Wall Street Reporters event is scheduled for Friday, May 1, 2020 at 12:30 pm ET / 9:30 am PT.Access:https://register.gotowebinar.com/register/8835183266170118926Dr. Pourhassan will provide an update on patient enrollment in eIND, Phase 2 and Phase 2b/3 COVID-19 trials. Updated 04 May 2020
16 Apr 2020 Other trial event According to a CytoDyn media release, Dr.Nader Pourhassan, will discuss about two trials (NCT04347239 and NCT04343651) at Wall Street Reporters NEXT SUPER STOCK Livestream event. Updated 18 May 2020
15 Apr 2020 Other trial event According to an CytoDyn media release, about 15 patients have been enrolled in our current Phase 2b mild-to-moderate COVID-19 patients. Updated 17 Apr 2020
15 Apr 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04343651). Updated 15 Apr 2020
13 Apr 2020 Other trial event According to an CytoDyn media release, the companyexpects to report the results to the FDA as quickly as possible. Updated 14 Apr 2020
13 Apr 2020 Other trial event According to an CytoDyn media release, as of last week, 12 patients have been treated in this study at 2 sites,3 more sites to initiate enrollment this week, for a total of 5 sites. As this is a double-blinded, placebo-controlled trial, results are not yet available. Updated 14 Apr 2020
07 Apr 2020 Other trial event According to a CytoDyn media release, Novant Health has initiated patient enrollment in the southeastern United States for this trial. Updated 09 Apr 2020
06 Apr 2020 Other trial event According to a CytoDyn media release, first two patients have been treated in this studies. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites. Updated 07 Apr 2020
02 Apr 2020 Status change - recruiting Status changed from planning to recruiting according to a CytoDyn media release. Updated 07 Apr 2020
27 Mar 2020 Other trial event According to a CytoDyn media release, the U.S. Food and Drug Administration (FDA) has suggested to file a second randomized protocol for all COVID-19 patients in severe condition next week, so as to preclude each physician from filing an emergency IND for every patient to be treated with leronlimab. Updated 01 Apr 2020
27 Mar 2020 Other trial event According to a CytoDyn media release, the company filed another round of modifications to its IND and protocol for a Phase 2 clinical trial at the suggestion of the U.S. Food and Drug Administration (FDA). Updated 01 Apr 2020
16 Mar 2020 Other trial event According to a CytoDyn media release, company hope to start the treatment study in the very near future. Updated 18 Mar 2020
16 Mar 2020 Other trial event According to a CytoDyn media release, company filed a modified IND and protocol for this trial. The modification came at the behest of the U.S. Food and Drug Administration (FDA) in response to the Companys filing of its IND and protocol for its Phase 2 clinical trial on March 9, 2020. Updated 18 Mar 2020
13 Mar 2020 Other trial event According to a CytoDyn media release, Dr. Jacob P. Lalezari, M.D. is currently leading the preparation o this study. Updated 16 Mar 2020
09 Mar 2020 Other trial event According to an CytoDyn media release, the company has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct this Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus disease 2019 (COVID-19). Updated 11 Mar 2020
03 Mar 2020 New trial record New trial record Updated 03 Mar 2020
28 Feb 2020 Other trial event According to a CytoDyn media release, Nader Pourhassan, Ph.D., president and chief executive officer, and Craig Eastwood, chief financial officer, will host an investment community conference call on March 5, 2020 to provide a comprehensive update on Filing of an IND and Phase 2 clinical trial protocol with the FDA for the treatment of coronavirus with leronlimab in the U.S Updated 03 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. CytoDyn. CytoDyn's Drs. Pourhassan and Patterson to Present Live at Wall Street Reporter's Event to Discuss Paper Recently Submitted for Publication and Positive Results of eIND COVID-19 Patients. Media-Rel 2020;.

    Media Release
  3. CytoDyn. CytoDyn to Hold Conference Call to Provide Updates on COVID-19 (Phase 2, 3 & eIND), Cancer (mTNBC, Phase 2 for 22 Solid Tumor Cancers), HIV (BLA, Monotherapy), NASH, GvHD and MS. Media-Rel 2020;.

    Media Release
  4. CytoDyn. Severely Ill COVID-19 Patient at Leading Southern California Medical Center Extubated Three Days After Treatment with CytoDyn's Leronlimab; Two Moderate COVID-19 Patients Removed from External Oxygen Following One Day of Treatment with Leronlimab and Discharged from Hospital. Media-Rel 2020;.

    Media Release
  5. CytoDyn. CytoDyn Files Modified IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140) and Advises Correction to Press Release Issued on March 12, 2020. Media-Rel 2020;.

    Media Release
  6. CytoDyn. CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19 Population. Media-Rel 2020;.

    Media Release
  7. CytoDyn. First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated. Media-Rel 2020;.

    Media Release
  8. CytoDyn. CytoDyn Appoints Jacob Lalezari, M.D. as Interim Chief Medical Officer. Media-Rel 2020;.

    Media Release
  9. CytoDyn. CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140). Media-Rel 2020;.

    Media Release
  10. CytoDyn. FDA Approves 54 Emergency INDs for Leronlimab Treatment of Coronavirus - CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible for Participation in Two Ongoing Clinical Trials in U.S. - CytoDyn Targets Enrollment Completion for its 75 Patient, Phase 2 Trial by End of May. Media-Rel 2020;.

    Media Release
  11. CytoDyn. CytoDyn to Hold Conference Call for Updates on Filing Phase 2 Trial with FDA for Treatment of Coronavirus in U.S., Status of BLA, Breakthrough Therapy Designation, Basket Trial for 22 Solid Tumor Cancers and Licensing Opportunities in Several Countries. Media-Rel 2020;.

    Media Release
  12. CytoDyn. CytoDyn to Present at Wall Street Reporter's ##8220##NEXT SUPER STOCK##8221## Livestream Event on April 17, 2020 at 12:30 pm ET / 9:30 am PT. Media-Rel 2020;.

    Media Release
  13. CytoDyn. Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3 Patients Discharged from Hospital; 1 Patient Scheduled for Discharge Today; 1 Patient with Severe Indications Discharged, for Total of 5 Patients Discharged. Media-Rel 2020;.

    Media Release
  14. Ajinomoto BioPharma Services. Ajinomoto Bio-Pharma Services Announces Manufacturing Partnership with CytoDyn for Drug Product Used in COVID-19 Clinical Trials. Media-Rel 2020;.

    Media Release
  15. Montefiore Health System. A Promising Drug for the Treatment of Severe Lung Inflammation in COVID-19 Patients: Montefiore-Einstein Scientists Lead Two Trials of Leronlimab. Media-Rel 2020;.

    Media Release
  16. CytoDyn. CytoDyn Files FDA-Suggested Modifications to IND and Protocol for Phase 2 Clinical Trial for COVID-19 Patients with Mild to Moderate Indications and a Second Randomized Protocol for All COVID-19 Patients in Severe Condition Will be Filed Next Week per FDA Recommendation. Media-Rel 2020;.

    Media Release
  17. CytoDyn. First Patient Treated with Leronlimab in Phase 2b/3 Trial for COVID-19. Media-Rel 2020;.

    Media Release
  18. CytoDyn. Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients. Media-Rel 2020;.

    Media Release
  19. CytoDyn. Novant Health Initiates Phase 2 COVID-19 Trial with CytoDyn's Leronlimab. Media-Rel 2020;.

    Media Release
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