EUCTR2020-001996-33-GBActive, not recruitingPhase 1
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)
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- CytoDyn, Inc.
- Enrollment
- 290
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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:
- •Severe Illness:
- •Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing within 5 days of screening
- •Symptoms of severe systemic illness/infection with COVID-19:
- •o 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
- •Clinical signs indicative of severe systemic illness/infection with COVID-19, with at least 1 of the following:
- •o RR = 30, HR = 125, SaO2 <93% on room air or requires > 2L oxygen by NC in order maintain SaO2 =93%, PaO2/FiO2 <300
- •No criteria for Critical Illness:
- •o 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
- •Critical Illness:
- •Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing within 5 days of screening
- •Evidence of critical illness, defined by at least 1 of the following:
- •o 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)
- •Shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg or requiring vasopressors)
- •Multiple organ dysfunction/failure
- •3. Subject is not intubated (or intubated within 72 hours of the screening). If intubated, positive end-expiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg.
- •4. Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
- •Note: Below are the examples of clinically significant and non-clinically significant ECG abnormalities:
- •- ECG findings indicative of acute myocardial infarction or acute ischemic changes would be considered clinically significant abnormalities.
- •- ECG finding such as atrial fibrillation, atrial flutter, paced rhythms in individuals who have undergone permanent pacemaker placement, evidence of prior infarction, unchanged stable conduction abnormalities e.g. right bundle branch block, or any other finding which does not significantly impact mortality would be considered non-clinically significant findings and subjects with these abnormal findings would be allowed to enroll in the study.
- •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 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.
- •Are the trial subjects under 18? no
- •Number of subjects f
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 vasopressors for >24 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. Subject participating in another study with for an investigational treatment for COVID-19.
- •Note: Subject who were prescribed hydroxychloroquine or chloroquine with or without azithromycin for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents.
- •8. Subjects who have received off-label immunomodulatory treatments for COVID-19 including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra.
Investigators
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