Status and phase
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About
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.
Full description
This is a Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
A single arm, non-randomized, open-label phase is added to the protocol after completion of enrollment in the Randomized Phase of the study.
The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female adult ≥ 18 years of age at time of screening.
Subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below:
A. Severe Illness:
AND
Symptoms of severe systemic illness/infection with COVID-19:
AND
Clinical signs indicative of severe systemic illness/infection with COVID-19, with at least 1 of the following:
AND
B. Critical Illness:
AND
Evidence of critical illness, defined by at least 1 of the following:
OR
OR
-Multiple organ dysfunction/failure
Subject, if intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg.
Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.
Exclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
394 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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