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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)

Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 18 May 2021

At a glance

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

    • 18 May 2021 According to a CytoDyn media release, the company intends to submit results of its newly completed topline report to various regulatory agencies including but not limited to agencies in India and the Philippines.
    • 18 May 2021 Topline results published in the CytoDyn Media Release.
    • 05 Apr 2021 According to a CytoDyn media release, anecdotal data and more than 90 approved eINDs (emergency IND) in U.S. along with the results of this study, is a compelling reason to move forward with the EUA request in the Philippines.

Trial Overview

Outcome

Primary endpoint met - positive

Purpose

The purpose of this adaptive design 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. The study has three phases lasting 28 days: Screening Period, Treatment Period, and Follow-Up Period.

Comments

According to a CytoDyn media release, the company intends to submit results of its newly completed topline report to various regulatory agencies including but not limited to agencies in India and the Philippines.
According to a CytoDyn media release, anecdotal data and more than 90 approved eINDs (emergency IND) in U.S. along with the results of this study, is a compelling reason to move forward with the Emergency Use Authorization (EUA) request in the Philippines (as of 5th Apr 2021).
The Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled. These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada (as of 8th Mar 2021).
MHRA had questions about this Phase 3 trial of severe-to-critical population interim analysis (as of 27th Oct 2020).
The Medicines and Healthcare product Regulatory Agency (MHRA) of the U.K. government requested a meeting with company to discuss the Company's request for Fast Track approval of leronlimab to treat COVID-19 patients with mil-to-moderate symptoms based upon the trial's Top-line Report and additional eIND data. On the suggestion of the MHRA, CytoDyn will submit this study to the Urgent Public Health (UPH) Research scheme to receive possible financial support from the trial sites and the government, if the UPH deems the Company's CD12 trial an urgent health issue (as of 2nd Sep 2020).
A treating physician has received authorization from the U.S. Food and Drug Administration (FDA) to administer leronlimab for a COVID-19 patient under emergency IND (eIND) (as of 22nd Dec 2020).

Primary Endpoints

Met on 08 Mar 2021

All-cause mortality at Day 28

description: Day 0 refers to the data of randomization/first treatment.
time_frame: Day 28 [1]

Met on 08 Mar 2021

All-cause mortality at Day 28 among participants who received dexamethasone as the prior or concomitant SoC for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population [1]

Other Endpoints

All-cause mortality at Day 14

description: Day 0 refers to the data of randomization/first treatment.
time_frame: Day 14

Change in clinical status of subject at Day 14 (on a 7 point 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.
time_frame: Day 14

Change in clinical status of subject at Day 28 (on a 7 point 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.
time_frame: Day 28

Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

description: 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
time_frame: Day 14 [2]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 394

    Actual: 394

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04347239 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001996-33 European Clinical Trials Database
CD12COVID19 -
CD12 -

Organisations

  • Sponsors CytoDyn
  • Affiliations CytoDyn

Trial Dates

  • Initiation Dates

    Actual : 15 Apr 2020

  • Primary Completion Dates

    Planned : 15 Jun 2021

  • End Dates

    Planned : 15 Oct 2021

Substudies/Extensions

This study has an open label portion.

Other Details

  • Design double-blind; multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II/III
  • Location United Kingdom; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
LeronlimabPrimary Drug Subcutaneous Injection

Placebo

Drug: Placebos (Placebos)

700mg Leronlimab

Drug: Leronlimab (700mg) weekly (Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5))

Results

Therapeutic efficacy

COVID-2019 infections
Phase III:

Top line results from a phase III study showed that following treatment with leronlimab, mortality is better than placebo. Day zero to day seven, critically ill patients receiving leronlimab (on day zero) experienced a mortality rate 78% lower than patients receiving placebo. Further, patients receiving the second dose of leronlimab achieved maximum benefit of 82% less mortality. However, the effects diminished from day 14 to day 21 and from day 21 to day 28, as the mortality rate decreased to 50% and 31%, respectively. The trial met all its secondary endpoints with statistically significant p-values for the critically ill subpopulation (62 patients). Previous result from a phase III study showed that following treatment with leronlimab five out of six patients on ECMO recovered. Earlier data showed that leronlimab demonstrated substantial improvement in the survival rate, and faster hospital discharge in critically ill patients with COVID-2019 infections. Leronlimaba was reported with a 24% reduction in all-cause mortality (primary endpoint of the study) versus the placebo. The average length of hospital stay was reduced by 6 days for patients who received leronlimab with Standard of Care (SoC) compared to placebo patients who received SoC only (p-value 0.005), using the Rank-ANCOVA model. In addition, patients received leronlimab demonstrated an improved probability of "discharged alive" at day 28 (28% versus 11%), a 166% better rate than in the placebo group. As a consequence of an imbalance among enrolled patients over 65 years of age and under 65, an age adjustment analysis was performed, which gave statistically significant results (p-value = 0.0319) for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab plus SoC compared to participants who received SoC alone in the placebo group in the overall modified intent-to-treat (mITT) population. Statistically significant results (p-value = 0.0552) reported for the primary endpoint among participants who received dexamethasone as the prior or concomitant SoC for COVID-2019 infections, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population. Amongst all patients in mITT, the primary endpoint was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. The population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65. With the age adjustment analysis in all other major secondary endpoints, there was consistent numerical superiority over the placebo group, and statistical significance towards secondary endpoints were also reported [3] [1] [4] .

Adverse events

Covid-2019 infections
Phase III:

In a phase III trial, leronlimab demonstrated continued safety for the treatment of severe-to-critical patients with COVID-2019 infections [4] .

Publications

  1. CytoDyn. CytoDyn to Release CD12 Trial Detailed Results via Form 8-K After Investment Community Webcast, Monday, March 8. Media-Rel 2021;.

    Media Release
  2. CytoDyn. CytoDyn to Submit Newly Completed Topline Report of CD12 Trial Results to Regulatory Agencies in Multiple Countries including India and Philippines. Media-Rel 2021;.

    Media Release
  3. CytoDyn. CytoDyn's Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab. Media-Rel 2021;.

    Media Release
  4. CytoDyn. First Compassionate Special Permit (CSP) Patient in Philippines Improved Significantly 35 hours After First Injection of Leronlimab and Released 3 Days Later. Media-Rel 2021;.

    Media Release
  5. CytoDyn. Blood Samples at Day 0, 3 and 7 for Severely Ill COVID-19 Patients Clearly Indicate Leronlimab Has Significantly Reduced the Cytokine Storm in All (7) Patients and All Patients Demonstrated Immunological Benefit at Both Day 3 and Day 7. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
CytoDyn 5 5 5

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Angela Ritter, MD Center for Advanced Research & Education (CARE)
-
Benjamin De La Rosa, MD Holy Name Medical Center USA
Blanca Sanchez
714-446-5620 Blanca.Sanchez@stjoe.org
show details
St. Jude Medical Center USA
Brian Delmonaco, MD Good Samaritan Hospital Corvallis USA
Caitlin Davis
617-735-4466 Cdavis6@bidmc.harvard.edu
show details
Beth Israel Deaconess Medical Center USA
David J Park, MD St. Jude Medical Center USA
Eric Whitman, MD Atlantic Health System Hospital USA
Harish Seethamraju, MD Montefiore Medical Center USA
Hinali Zaveri, MD
713-873-2353 hzaveri@bcm.edu
show details
Baylor College of Medicine USA
Jane Wilson
718-920-7916
show details
Montefiore Medical Center USA
Jordan Lake
713-500-6767 Jordan.e.lake@uth.tmc.edu
show details
University of Texas USA
Jordan Lake, MD University of Texas USA
Julie Recknor
770-534-5154 jrecknor@carega.net
show details
Center for Advanced Research & Education (CARE)
-
Kalpalatha Guntupalli, MD Baylor College of Medicine 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 Sciences University USA
Michael Morgan, MD Novant Health USA
Nancy Lopez
310-794-8043 NancyRLopez@mednet.ucla.edu
show details
UCLA USA
Otto Yang, MD UCLA USA
Pailing Richards
704-996-7627 pcrichards@novanthealth.org
show details
Novant Health USA
Patty Kiledjian
201-541-6312 pkiledjian@holyname.org
show details
Holy Name Medical Center USA
Sabrina Tan, MD Beth Israel Deaconess Medical Center USA
Samantha Wang
214-818-2521 Samantha.wang@bswhealth.org
show details
Baylor Scott & White Research Institute
-
Stephanie Mock
541-768-4352 stmock@samhealth.org
show details
Good Samaritan Hospital Corvallis USA
Subroto Paul, MD St. Barnabas USA
Uriel Sandkovsky Baylor Scott & White Research Institute
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Atlantic Health System Hospital Morristown, New Jersey USA
Baylor College of Medicine Houston, Texas USA
Baylor Scott & White Research Institute Dallas, Texas USA
Beth Israel Deaconess Medical Center Boston, Massachusetts USA
Center for Advanced Research & Education (CARE) Gainesville, Georgia USA
CytoDyn, Inc.
-
-
Good Samaritan Hospital Corvallis Corvallis, Oregon USA
Holy Name Medical Center Teaneck, New Jersey USA
Montefiore Medical Center Bronx, New York USA
Novant Health Winston-Salem, North Carolina USA
Ohio Health Columbus, Ohio USA
Oregon Health and Sciences University Portland, Oregon USA
St. Barnabas Livingston, New Jersey USA
St. Jude Medical Center Fullerton, California USA
UCLA Los Angeles, California USA
University of Texas Houston, Texas USA

Trial History

Event Date Event Type Comment
18 May 2021 Other trial event According to a CytoDyn media release, the company intends to submit results of its newly completed topline report to various regulatory agencies including but not limited to agencies in India and the Philippines. Updated 24 May 2021
18 May 2021 Results Topline results published in the CytoDyn Media Release. Updated 24 May 2021
15 Apr 2021 Other trial event Last checked against Clinicaltrials.gov record. Updated 15 Apr 2021
05 Apr 2021 Other trial event According to a CytoDyn media release, anecdotal data and more than 90 approved eINDs (emergency IND) in U.S. along with the results of this study, is a compelling reason to move forward with the EUA request in the Philippines. Updated 12 Apr 2021
05 Apr 2021 Results Results (n=384) presented in a CytoDyn media release. Updated 12 Apr 2021
18 Mar 2021 Other trial event Planned number of patients changed from 390 to 394. Updated 23 Mar 2021
18 Mar 2021 Completion date Planned End Date changed from 1 Apr 2021 to 15 Oct 2021. Updated 23 Mar 2021
18 Mar 2021 Other trial event Planned primary completion date changed from 31 Dec 2020 to 15 Jun 2021. Updated 23 Mar 2021
08 Mar 2021 Results Results published in the CytoDyn Media Release Updated 15 Mar 2021
08 Mar 2021 Other trial event According to a CytoDyn media release, the Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled. These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada. Updated 12 Mar 2021
08 Mar 2021 Other trial event According to a CytoDyn media release, MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial. To date, an additional 46 patients have been enrolled, but the results have not yet been communicated to any agency. Updated 12 Mar 2021
08 Mar 2021 Other trial event According to a CytoDyn media release, company has submitted protocol to U.S. FDA for immediate enrollment of 140 critical COVID-19 patients with same sites as CD12 trial enrollment to commence upon FDA comments. Updated 12 Mar 2021
08 Mar 2021 Other trial event According to a CytoDyn media release, the company will release data from this trial via a Form 8-K after the investment community webcast. Updated 11 Mar 2021
08 Mar 2021 Other trial event According to a CytoDyn media release, trial results are being prepared to be submitted for publication. Updated 11 Mar 2021
08 Mar 2021 Results Results published in the CytoDyn media release. Updated 11 Mar 2021
08 Mar 2021 Endpoint met Primary endpoint (All-cause mortality at Day 28 among participants who received dexamethasone as the prior or concomitant SoC for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population) has been met, according to a CytoDyn media release. Updated 11 Mar 2021
08 Mar 2021 Endpoint met Primary endpoint (All-cause mortality at Day 28) has been met, according to a CytoDyn media release. Updated 11 Mar 2021
22 Feb 2021 Other trial event According to a CytoDyn media release, the trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators. The company expects to release CD12 data and complete discussions with various regulatory agencies within 2 to 3 weeks. Updated 25 Feb 2021
29 Jan 2021 Other trial event According to a CytoDyn media release, results are expected in early February 2021. Updated 05 Feb 2021
24 Dec 2020 Other trial event According to a CytoDyn media release, the CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on Monday, December 28, 2020. Upon clearance, each CD12 participating clinical trial site will have the option of enrolling additional qualified patients, with all patients receiving leronlimab. Treatment of qualified patients will continue until the trials data is unblinded. Updated 31 Dec 2020
24 Dec 2020 Other trial event According to a CytoDyn media release, U.S. Food and Drug Administration (FDA) provided guidance to the Company to add an open-label extension to its Phase 3 trial (CD12) and specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12. Updated 31 Dec 2020
22 Dec 2020 Other trial event According to a CytoDyn media release, a treating physician has received authorization from the U.S. Food and Drug Administration (FDA) to administer leronlimab for a COVID-19 patient under emergency IND (eIND). Updated 30 Dec 2020
15 Dec 2020 Other trial event According to a CytoDyn media release, the 390-patient data will be analyzed in approximately 28 days, with expected results to be announced in mid January 2021. Updated 23 Dec 2020
15 Dec 2020 Status change - active, no longer recruiting According to a CytoDyn media release, Status changed from recruiting to active, no longer recruiting. Updated 23 Dec 2020
23 Nov 2020 Other trial event According to a CytoDyn media release, it has reached enrollment of 293 patients thereby meeting the requested criteria for a second interim efficacy analysis by DSMC.. After the first interim analysis, the DSMC requested a second interim analysis of all data after enrollment had reached 293 patients or 75% of the total patients for the trial. The company also announced its intention to complete patient enrolment before end of 2020. Updated 04 Dec 2020
11 Nov 2020 Other trial event According to a CytoDyn media release, this trial enrollment is currently at 236 patients. Updated 27 Nov 2020
27 Oct 2020 Other trial event According to a CytoDyn media release, MHRA had questions about this Phase 3 trial of severe-to-critical population interim analysis. Updated 04 Nov 2020
20 Oct 2020 Other trial event According to a CytoDyn media release, this trial enrollment is currently at 230 patients, with the enrollment goal of 293 patients potentially in 4-6 weeks and full enrollment (390) before year end. Clinical trial sites in the U.K. are expected to initiate enrollment in the coming days. Updated 27 Oct 2020
20 Oct 2020 Other trial event According to a CytoDyn media release, the DSMC has requested another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days. Updated 27 Oct 2020
20 Oct 2020 Other trial event According to a CytoDyn media release, the company announced recommendations from the Data Safety Monitoring Committee (DSMC) following its review of the interim analysis (n=195). DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint. Updated 27 Oct 2020
15 Oct 2020 Other trial event According to a CytoDyn media release, the recommendations of the Data Safety Monitoring Committee (DSMC) following interim analysis ( n = 195) from this study will be hosted at the web conference on 20 Oct 2020. Updated 21 Oct 2020
07 Sep 2020 Other trial event New source identified and integrated(European Clinical Trials Database;EudraCT2020-001996-33). Updated 07 Sep 2020
02 Sep 2020 Other trial event According to a CytoDyn media release, an interim analysis on the first 195 patients will be performed in approximately four weeks with results anticipated in mid-October. Updated 04 Sep 2020
02 Sep 2020 Other trial event According to a CytoDyn media release, in this meeting the company will present a summary of its BLA for HIV in conjunction with our request for fast track approval for COVID-19 indication. Updated 04 Sep 2020
02 Sep 2020 Other trial event According to a CytoDyn media release, On the suggestion of the MHRA, CytoDyn will submit this study to the Urgent Public Health (UPH) Research scheme to receive possible financial support from the trial sites and the government, if the UPH deems the Company's CD12 trial an urgent health issue. Updated 04 Sep 2020
02 Sep 2020 Other trial event According to a CytoDyn media release, the Medicines and Healthcare product Regulatory Agency (MHRA) of the U.K. government requested a meeting with company to discuss the Company's request for Fast Track approval of leronlimab to treat COVID-19 patients with mil-to-moderate symptoms based upon the trial's Top-line Report and additional eIND data. Updated 04 Sep 2020
25 Aug 2020 Other trial event According to a CytoDyn media release, the company has reached the requisite number of enrolled patients i.e 195 in this study to perform an interim analysis following the 28-day phase of the trial. Interim analysis to commence after 28 days with results anticipated by mid-October 2020. Updated 27 Aug 2020
20 Aug 2020 Other trial event According to a CytoDyn media release, the MHRAs decision follows several months of its review of CytoDyns manufacturing processes and leronlimabs safety profile. Patient enrollment to commence immediately. Updated 25 Aug 2020
20 Aug 2020 Other trial event According to a CytoDyn media release, the company announced today that the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for this ongoing Phase 3 COVID-19 trial in the United Kingdom. Updated 25 Aug 2020
19 Aug 2020 Other trial event According to a Cytodyn media release, enrollment is now at 182 and the company anticipates enrollment will reach 195 by the end of August. Updated 25 Aug 2020
04 Aug 2020 Other trial event According to a Cytodyn media release, this study has currently enrolled 169 patients and the Company will conduct a full interim analysis once 195 patients are enrolled. Updated 07 Aug 2020
04 Aug 2020 Other trial event According to a CytoDyn media release, the independent Data Safety Monitoring Committee (DSMC) completed its first safety review (n=149 subjects), and reported it saw no cause to modify the study. Updated 07 Aug 2020
13 Jul 2020 Other trial event According to a CytoDyn media release, periodic safety review by Data Safety Monitoring Committee (DSMC) for ongoing Phase 3 study (severe/critical population) is planned for next week. Results is expected to be announced in July. Updated 17 Jul 2020
11 Jun 2020 Other trial event According to an CytoDyn media release, the company will do an interim analysis of patient data in this Phase 3 trial for severe and critically ill COVID-19 patients and hope to have important results in 2 to 3 weeks. Updated 15 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
07 May 2020 Other trial event According to an CytoDyn media release, Novant Health is initiating patient enrollment in CytoDyns Phase 2b/3 trial for severely and critically ill COVID-19 patients. Updated 11 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
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
17 Apr 2020 Other trial event New source identified and integrated: (ClinicalTrials.gov: US National Institutes of Health: NCT04347239). Updated 17 Apr 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 30 patients have been administered leronlimab under Emergency Investigational New Drug (EIND) authorizations granted by the U.S. Food and Drug Administration (FDA) Updated 20 Apr 2020
15 Apr 2020 Other trial event According to an CytoDyn media release, Based on the promising results from the EIND patients, we are hopeful that this randomized, placebo-controlled trial will give us the data needed for FDA approval and ultimately the basis to use leronlimab to save lives in this pandemic Updated 17 Apr 2020
15 Apr 2020 Other trial event According to an CytoDyn media release, Patients enrolled in this trial are expected to be administered leronlimab for two weeks Updated 17 Apr 2020
15 Apr 2020 Other trial event According to an CytoDyn media release, the treatment of the first patient with leronlimab is done in its Phase 2b/3 trial for severe and critical COVID-19 indications Updated 17 Apr 2020
13 Apr 2020 Other trial event According to an CytoDyn media release, First site has been cleared to enroll patients in this study beginning today. Updated 14 Apr 2020
09 Apr 2020 Protocol amendment According to a Cytodyn media release, the study protocol was revised with change in duration of primary endpoint from 14 days to 28 days and change in planned enrollment from 342 to 390. Updated 13 Apr 2020
09 Apr 2020 Other trial event Planned number of patients changed from 342 to 390, according to a Cytodyn media release. Updated 13 Apr 2020
09 Apr 2020 Results Results published in the Cytodyn media release Updated 13 Apr 2020
07 Apr 2020 New trial record New trial record Updated 07 Apr 2020
06 Apr 2020 Other trial event According to a Cytodyn media release,the Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy. Updated 07 Apr 2020
01 Apr 2020 Other trial event According to a Cytodyn media release, the company expects to enroll patients in this study and a phase II study, very quickly under the same IND that was provided with a safe to proceed letter from the FDA. Updated 07 Apr 2020
01 Apr 2020 Other trial event According to a Cytodyn media release, the company has filed a second clinical trial protocol with the U.S. Food and Drug Administration (FDA) to treat severely ill COVID-19 patients with leronlimab. This trial will be conducted under the same FDA-approved IND as the Company recently initiated Phase 2 clinical trial ( CTP 319302) to treat COVID-19 patients with mild-tomoderate indications Updated 07 Apr 2020

References

  1. CytoDyn. CytoDyn to Release CD12 Trial Detailed Results via Form 8-K After Investment Community Webcast, Monday, March 8. Media-Rel 2021;.

    Media Release
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  3. CytoDyn. CytoDyn to Submit Newly Completed Topline Report of CD12 Trial Results to Regulatory Agencies in Multiple Countries including India and Philippines. Media-Rel 2021;.

    Media Release
  4. CytoDyn. CytoDyn's Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab. Media-Rel 2021;.

    Media Release
  5. 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
  6. CytoDyn. CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial. Media-Rel 2020;.

    Media Release
  7. CytoDyn. CytoDyn Reaches Enrollment Target of 293 Patients for 2nd DSMC Interim Analysis of Phase 3 COVID-19 Trial and Expects to Enroll the Remaining 97 Patients in the Next Few Weeks to Complete the Trial This Year. Media-Rel 2020;.

    Media Release
  8. CytoDyn. CytoDyn Receives Positive DSMC Recommendation for Leronlimab Phase 3 COVID-19 Trial with No Safety Concerns. Media-Rel 2020;.

    Media Release
  9. CytoDyn. CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19. Media-Rel 2021;.

    Media Release
  10. CytoDyn. After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.'s MHRA Accepts CytoDyn's Request to Enroll in its Current Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms. Media-Rel 2020;.

    Media Release
  11. CytoDyn. Update on HIV-BLA-PDUFA: FDA requested more information to complete a substantive review. No additional trials required. CytoDyn plans to submit the requested information and will ask for a Type A meeting with the FDA per the agency's suggestion. Media-Rel 2020;.

    Media Release
  12. 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
  13. CytoDyn. CytoDyn in Discussions with U.S. FDA, MHRA and Health Canada After Unblinding its CD12 Trial Data for Severe-to-Critically Ill COVID-19 Patients. Media-Rel 2021;.

    Media Release
  14. 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
  15. CytoDyn. CytoDyn Completes Second Non-dilutive $28.5 Million Convertible Note Financing with Conversion Rate at $10.00 Per Share Without Warrants to Help Expedite License Applications Here and Abroad and Successful COVID-19 Trials. Media-Rel 2020;.

    Media Release
  16. European Clinical Trials Database. Trial-Reg 2021;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  17. CytoDyn. First Compassionate Special Permit (CSP) Patient in Philippines Improved Significantly 35 hours After First Injection of Leronlimab and Released 3 Days Later. Media-Rel 2021;.

    Media Release
  18. CytoDyn. CytoDyn Reached Its Enrollment Target for Phase 2 COVID-19 Trial for Mild to Moderate Indication Primary End Point Announcement Is Next. Media-Rel 2020;.

    Media Release
  19. CytoDyn. U.K. MHRA Grants Meeting to CytoDyn to Discuss Fast Track Approval of Leronlimab for COVID-19 Patients. Media-Rel 2020;.

    Media Release
  20. CytoDyn. FDA Resumes eIND Approval for Severe-to-Critical COVID-19 Patients Use of Vyrologix(TM) (leronlimab) Following Full Enrollment in CytoDyn's Phase 3 Trial. Media-Rel 2020;.

    Media Release
  21. CytoDyn. CytoDyn Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Weeks. Media-Rel 2020;.

    Media Release
  22. CytoDyn. CytoDyn Requests ##8220##Fast Track Approval##8221## for COVID-19 Patients from U.K.'s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results. Media-Rel 2020;.

    Media Release
  23. CytoDyn. U.K. MHRA Clears CytoDyn to File its BLA for Leronlimab as One Injection per Week for Combination HIV Therapy. Media-Rel 2020;.

    Media Release
  24. CytoDyn. CytoDyn to Hold Webcast on October 20 to Discuss DSMC's Recommendations from the Interim Analysis of the Phase 2b/3 Clinical Trial for Severe-to-Critical COVID-19 Patients. Media-Rel 2020;.

    Media Release
  25. CytoDyn. Novant Health Initiates Phase 2b/3 Trial with CytoDyn's Leronlimab for Severely and Critically Ill COVID-19 Patients. Media-Rel 2020;.

    Media Release
  26. CytoDyn. CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms. Media-Rel 2020;.

    Media Release
  27. 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
  28. CytoDyn. FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn's Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded. Media-Rel 2020;.

    Media Release
  29. CytoDyn. Chiral Pharma Corp. to Assist Philippine Physicians Apply for Compassionate Special Permit (CSP) to Access CytoDyns Leronlimab for COVID-19 Patients, as Philippines FDA Reviews Each Application for Approval to Sell Leronlimab for CSP Use. Media-Rel 2021;.

    Media Release
  30. CytoDyn. CytoDyn Completes Enrollment for Phase 3 Registrational Trial for 390 Patients with Severe-to-Critical COVID-19 . Media-Rel 2020;.

    Media Release
  31. 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
  32. 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
  33. 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
  34. 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
  35. CytoDyn. Blood Samples at Day 0, 3 and 7 for Severely Ill COVID-19 Patients Clearly Indicate Leronlimab Has Significantly Reduced the Cytokine Storm in All (7) Patients and All Patients Demonstrated Immunological Benefit at Both Day 3 and Day 7. Media-Rel 2020;.

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

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

    Media Release
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