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)
Latest Information Update: 05 Jan 2023
At a glance
- Drugs Leronlimab (Primary)
- Indications COVID 2019 infections; Respiratory insufficiency
- Focus Proof of concept; Therapeutic Use
- Sponsors CytoDyn
- 02 Aug 2021 Primary endpoint (Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough)) has not been met, according to a CytoDyn media release.
- 23 Sep 2020 According to a CytoDyn media release, this study has been selected for an oral presentation at the upcoming Special isirv-Antiviral Group Conference on Therapeutics for COVID-19.The Conference is sponsored by the International Society for Influenza and other Respiratory Virus Diseases, an independent and international scientific professional society promoting the prevention, detection, treatment, and control of influenza and other respiratory virus disease.
- 10 Sep 2020 According to a CytoDyn media release, the company will host an investment community conference call on Wednesday, September 16, 2020 to provide updates regarding the U.S. Food and Drug Administration (FDA) emergency IND (eIND) program.
Most Recent Events
Trial Overview
Outcome
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.
Comments
According to a CytoDyn media release, the company has provided Top-line report from the trial to Medicines and Healthcare Products Regulatory Agency (MHRA) and requested regulatory pathway for Fast Track approval noting the data of this trial.
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 [1]
Other Endpoints
Time to Clinical Resolution (TTCR)
description: Defined as the time from initiation of study treatment to the resolution of clinical symptoms (fever, myalgia, dyspnea, cough). Data presented how the number of days at which a certain percentage of patients achieve resolution of symptoms, i.e., 50% of patients on placebo saw resolution of symptoms in 15 days, and 15 days for patients on leronlimab. The hazard ratio was 0.781, 95% Confidence Interval 0.43, 1.41 and the p-value was 0.4138. TTCR is defined as the duration from date of first exposure to treatment to the first occurrence of total symptom score equals 0. time_frame: Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough).
Incidence of Hospitalization
description: Number of patients requiring hospitalization time_frame: From visit 2 (day 0) through day 14 (in days)
Duration (Days) of Hospitalization
description: Duration of hospitalization in days time_frame: Total duration of hospitalization between visit 2 (day 0) in days and end of treatment
Incidence of Mechanical Ventilation
description: Incidence of mechanical ventilation supply time_frame: Total duration of mechanical ventilation since visit 2 (day 0) (days)
Duration of Mechanical Ventilation Supply
description: Duration (days) of mechanical ventilation supply time_frame: Duration of mechanical ventilation since visit 2 (day 0) (days
Incidence of Oxygen Use
description: Incidence of oxygen use over course of treatment time_frame: Use of oxygen since visit 2 (day 0) to end of treatment
Duration of Oxygen Use
description: Duration of oxygen use in days time_frame: Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days)
Mortality at Day 14
description: Incidence of mortality at day 14 time_frame: Mortality at EOT (day 14)
Time to Return to Normal Activity
description: Time to return to normal activity from initiation of study treatment defined as duration from date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities" time_frame: Date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"
Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14
description: NEWS2 is an assessment based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) developed by the Royal College of Physicians (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2). Respiratory rate (bpm) scores 0-3; Sp02 (on room air or suppl) scores 0-3; SpO2 (hypercapnic resp failure) scores 0-3; room air or supplemental O2 scores 0 (room) or 2 (suppl); temperature - scores 0-3; systolic BP scores 0-3; pulse (bpm) scores 0-3; consciousness - alert (score 0) vs. new onset confusion (score 3). The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring. Change shown is positive or negative from baseline, with a negative number indicating improvement (i.e., a decrease in total score). time_frame: Baseline to Day 3, 7 and 14
Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14
description: Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 for patients with paired values time_frame: Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14
Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14
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: Assessments performed Day 0 (first treatment is Visit 2, day 0), Visit 3 (3+/- 1 day after first treatment) Visit 4 (second treatment, 7+/- 1 day from V2, day7) and end of treatment (7+/- 1 day from V4, day 14)
Change in Size of Lesion Area by Chest Radiograph or CT
description: Change in size of lesion area by chest radiograph or CT - exploratory endpoint time_frame: Day 14
Change From Baseline in Serum Cytokine and Chemokine Levels
description: Change from baseline in serum cytokine and chemokine levels at day 3, day 7 and day 14 time_frame: Days 3, 7, and 14
Change From Baseline in CCR5 Receptor Occupancy Levels for Tregs and Macrophages
description: Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages at day3, day 7 and day 14 time_frame: Days 3, 7, and 14
Change From Baseline in CD3+, CD4+ and CD8+ T Cell Count
description: Change from baseline in CD3+, CD4+ and CD8+ T cell count at day 3, day 7 and day 14 time_frame: Days 3, 7, and 14 [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | treatment | - |
| Respiratory insufficiency | treatment | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04343651 | C-C chemokine receptor type 5 (CCR5) | Outcome Measure |
| CD3 gamma chain (CD3G) | Outcome Measure | |
| T-Cell differentiation antigen CD8 | Outcome Measure | |
| T-cell receptor CD3-epsilon (CD3e) | Outcome Measure | |
| T-cell receptor T3 delta chain (CD3d) | Outcome Measure | |
| T-cell surface antigen CD4 | Outcome Measure |
Subjects
- Subject Type patients
-
Number
Planned: 75
Actual: 86
- 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 | - |
| CD10 | - |
Organisations
- Sponsors CytoDyn
- Affiliations CytoDyn
Trial Dates
-
Initiation Dates
Actual : 01 Apr 2020
-
Primary Completion Dates
Planned : 04 Dec 2020
Actual : 21 Jul 2020
-
End Dates
Planned : 31 Aug 2020
Actual : 20 Sep 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
The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections. Drug: Placebo (Placebo)
700mg Leronlimab
Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections. 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
Results
Therapeutic efficacy
Phase II: In data from eight patients with severe COVID-2019 infections in phase II trial, treatment with leronlimab for three days demonstrated improvement in cytokines, IL-6, increase in CD8 T-lymphocytes percentages and normalisation of CD4/CD8 ratios [3] .
A severly ill patient with COVID-2019 infection, treated with leronlimab under Emergency IND (EIND) in a phase II trial, showed improvement in clinical symptoms within 24 hour post therapy and was removed from external ventilation three days later. The patient was treated earlier with IL-6 inhibitors and antiretroviral therapy which did not improve the condition of the patient. Two more patients with moderate COVID-2019 infections, who received leronlimab under an EIND also displayed clinical improvement. These patients were removed from external oxygen support one day following leronlimab treatment, and subsequently discharged from the hospital. Subsequently, a total of five patients were relieved from oxygen support. Updated data showed that a total of 38 infected patients were extubated, improved, or were discharged. Four of 11 critically ill patients survived post-treatment [4] [5] [6] .
Primary endpoint shows early clinical improvement in symptom score at day 3 in patients receiving leronlimab as demonstrated by top-line results from phase II trial in mild-to-moderate COVID-2019 infected patients. Clinical improvement assessed by change in total clinical symptom score. At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The subgroup analysis indicated that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo. Leronlimab also demonstrated statistically significant improvement versus placebo in key secondary efficacy endpoint, National Early Warning Score 2 scale (which is an objective scale to identify patients at risk and being used as an endpoint). In all treated patients, at the end of treatment (or day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in the National Early Warning Score 2 compared to patients in the placebo group (50% vs 20%; p=0.0223). Similar, statistically significant, results were observed at day 3 and day 14 in the analysis of per protocol population (p<0.03 and p<0.02, respectively) [7] .
Adverse events
Phase II:
In a phase II trial that enrolled 84 patients with COVID-19 infections, leronlimab treatment was well tolerated. In leronlimab group, 34% (19 of 56 patients) at least one AE was reported, compared to 50% (14 of 28 patients) treated with placebo. During the trial, total 19 serious adverse events (SAEs) were observed. Eleven (11) SAEs were reported in six patients (6/28; 21.4%) receiving placebo compared to eight SAEs in five patients (5/56; 8.9%) receiving leronlimab. SAEs noted in the leronlimab arm were not drug related. One death was reported following 33 days of enrolment out from the 84 patients treated which was noted to be treatment unrelated [8] [9] .
Results from phase II trial showed that the incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) were lower in the leronlimab group compared to the placebo group. Patients treated with placebo were more than twice as likely to experience SAEs or AEs compared to patients treated with leronlimab. Treatment with leronlimab demonstrated reductions in both serious adverse events, as well as predictors of pulmonary collapse in patients with mild-to-moderate COVID-19 infections. The results also demonstrated that CCR5 blockade by leronlimab given as a weekly subcutaneous injection is reasonably safe and associated with fewer adverse events than when compared to placebo [7] .
Publications
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CytoDyn. CytoDyn Announces Clinically Significant Top-line Results from its Phase 2 Trial in Mild-to-Moderate COVID-19 Patients. Media-Rel 2020;.
Media Release -
CytoDyn. Impressive Results From CytoDyn's Phase 2 Covid-19 Trial. Media-Rel 2020;.
Media Release -
CytoDyn. UPDATE - Impressive Results From CytoDyn's Phase 2 COVID-19 Trial. Media-Rel 2020;.
Media Release -
Targeted oncology. Leronlimab Shows Statistically Significant Improvement in Efficacy Outcome in Mild-to-Moderate COVID-19. Media-Rel 2020;.
Media Release -
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
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 Jan 2023 | Other trial event | Last checked against Clinicaltrials.gov record. Updated 05 Jan 2023 |
| 02 Aug 2021 | Endpoint not met | Primary endpoint (Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough)) has not been met, according to a CytoDyn media release. Updated 09 Aug 2021 |
| 23 Sep 2020 | Other trial event | According to a CytoDyn media release, this study has been selected for an oral presentation at the upcoming Special isirv-Antiviral Group Conference on Therapeutics for COVID-19.The Conference is sponsored by the International Society for Influenza and other Respiratory Virus Diseases, an independent and international scientific professional society promoting the prevention, detection, treatment, and control of influenza and other respiratory virus disease. Updated 25 Sep 2020 |
| 10 Sep 2020 | Other trial event | According to a CytoDyn media release, the company will host an investment community conference call on Wednesday, September 16, 2020 to provide updates regarding the U.S. Food and Drug Administration (FDA) emergency IND (eIND) program. Updated 16 Sep 2020 |
| 28 Aug 2020 | Other trial event | According to a CytoDyn media release, the company will host an investment community conference call on Wednesday, September 2 addressing the Status of Emergency Use Approval for COVID-19, CD10 trial in U.S. Updated 02 Sep 2020 |
| 20 Aug 2020 | Biomarker Update | Biomarkers information updated Updated 17 Sep 2021 |
| 19 Aug 2020 | Results | Results published in the CytoDyn Media Release. Updated 09 Aug 2021 |
| 19 Aug 2020 | Status change - completed | Status changed from active, no longer recruiting to completed, as reported in a CytoDyn media release Updated 25 Aug 2020 |
| 19 Aug 2020 | Other trial event | According to a CytoDyn media release, the company has provided Top-line report from the trial to Medicines and Healthcare Products Regulatory Agency (MHRA) and requested regulatory pathway for Fast Track approval noting the data of this trial. Updated 25 Aug 2020 |
| 19 Aug 2020 | Completion date | Planned End Date changed from 31 Aug 2021 to 31 Aug 2020. Updated 24 Aug 2020 |
| 13 Aug 2020 | Results | Results published in the Targeted oncology Media Release. Updated 09 Aug 2021 |
| 11 Aug 2020 | Other trial event | According to an CytoDyn media release, it will host an investment community conference to provide a comprehensive overview of the compelling results from this trial. Updated 14 Aug 2020 |
| 11 Aug 2020 | Other trial event | According to an CytoDyn media release, the company will submit its Top-line Report for this trial to the U.S. Food and Drug Administration for review later this week. Updated 14 Aug 2020 |
| 11 Aug 2020 | Results | Results published in the CytoDyn Media Release Updated 14 Aug 2020 |
| 10 Aug 2020 | Completion date | Planned End Date changed from 4 Apr 2021 to 31 Aug 2021. Updated 12 Aug 2020 |
| 07 Aug 2020 | Other trial event | According to an CytoDyn media release, the company announced that it will submit requests for pre-submission meetings (equivalent to pre-BLA meeting in U.S.) in the U.K. for leronlimab for emergency approval of leronlimab for COVID-19 patients with mild-to-moderate symptoms. Updated 12 Aug 2020 |
| 21 Jul 2020 | Other trial event | According to an CytoDyn media release, the efficacy portion of the trial will be announced along with a full report as soon as statistical analyses are completed. Updated 27 Jul 2020 |
| 21 Jul 2020 | Results | Results presented in a CytoDyn Media Release. Updated 27 Jul 2020 |
| 21 Jul 2020 | Other trial event | According to an CytoDyn media release, the results from efficacy portion of the trial will be announced along with a full report as soon as statistical analyses are completed. A total of 84 patients were treated across 8 study sites. Updated 24 Jul 2020 |
| 21 Jul 2020 | Results | Safety Results published in the CytoDyn Media Release. Updated 24 Jul 2020 |
| 13 Jul 2020 | Other trial event | According to an CytoDyn media release, company is planning to lock and unblind the data later this week. Data is expected to be announced in July. Updated 17 Jul 2020 |
| 03 Jul 2020 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting, according to a CytoDyn media release. Updated 08 Jul 2020 |
| 11 Jun 2020 | Other trial event | According to an CytoDyn media release, the company announced today that it has met its 75 patient enrollment for this study and primary endpoint announcement is next. The Company expects the evaluation clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75. 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 |
| 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 |
Table of Contents
References
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CytoDyn. CytoDyn Announces That Director Nominations by Rosenbaum/Patterson Activist Group Are Invalid. Media-Rel 2021;.
Media Release -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
CytoDyn. Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients. Media-Rel 2020;.
Media Release -
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 -
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 -
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 -
CytoDyn. CytoDyn Announces Clinically Significant Top-line Results from its Phase 2 Trial in Mild-to-Moderate COVID-19 Patients. Media-Rel 2020;.
Media Release -
CytoDyn. Impressive Results From CytoDyn's Phase 2 Covid-19 Trial. Media-Rel 2020;.
Media Release -
CytoDyn. UPDATE - Impressive Results From CytoDyn's Phase 2 COVID-19 Trial. Media-Rel 2020;.
Media Release -
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 -
Targeted oncology. Leronlimab Shows Statistically Significant Improvement in Efficacy Outcome in Mild-to-Moderate COVID-19. Media-Rel 2020;.
Media Release -
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 -
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 -
CytoDyn. CytoDyn to Hold Conference Call on August 12 to Discuss Impressive Results from its Phase 2 COVID-19 Trial. Media-Rel 2020;.
Media Release -
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;.
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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;.
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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;.
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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;.
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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;.
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CytoDyn. CytoDyn Appoints Jacob Lalezari, M.D. as Interim Chief Medical Officer. Media-Rel 2020;.
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CytoDyn. CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140). Media-Rel 2020;.
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CytoDyn. CytoDyn's Phase 2 Study of Leronlimab for Mild-to-Moderate COVID-19 Selected for Oral Presentation at the Special isirv-AVG Virtual Conference on 'Therapeutics for COVID-19. Media-Rel 2020;.
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CytoDyn. CytoDyn to Hold Conference Call on September 16 to Provide Update on Discussions with FDA and MHRA for COVID-19 and FDA Meeting on BLA Filing. Media-Rel 2020;.
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CytoDyn. CytoDyn Announces Execution of Exclusive Agreement with American Regent for Distribution and Supply of Leronlimab for Treatment of COVID-19 in United States. Media-Rel 2020;.
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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;.
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CytoDyn. CytoDyn Seeks UK Approval of Leronlimab for HIV and COVID-19. Media-Rel 2020;.
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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;.
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Ajinomoto BioPharma Services. Ajinomoto Bio-Pharma Services Announces Manufacturing Partnership with CytoDyn for Drug Product Used in COVID-19 Clinical Trials. Media-Rel 2020;.
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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;.
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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;.
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CytoDyn. CytoDyn to Hold Conference Call on September 2 to Provide Update on Timelines for Multiple Regulatory and Clinical Initiatives Including COVID-19 Potential Approvals. Media-Rel 2020;.
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CytoDyn. First Patient Treated with Leronlimab in Phase 2b/3 Trial for COVID-19. Media-Rel 2020;.
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CytoDyn. CytoDyn Announces Upcoming Retirement of Dr. David Welch from its Board of Directors. Media-Rel 2020;.
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CytoDyn. Novant Health Initiates Phase 2 COVID-19 Trial with CytoDyn's Leronlimab. Media-Rel 2020;.
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