Status:
SUSPENDED
Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia
Lead Sponsor:
Hospital Israelita Albert Einstein
Collaborating Sponsors:
CytoDyn, Inc.
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5). Disruption of the C-C chemokine ligand 5 (CCL5)-CCR5 axis via leronlimab-...
Detailed Description
Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5). CCR5 is expressed predominantly on T cells but also found on macrophages,...
Eligibility Criteria
Inclusion
- Male or females aged ≥ 18 years
- Moderately ill patients with COVID-19 (defined as Ordinal Scale of 5 or 6): Hospitalized, requiring supplemental oxygen or hospitalized, on non-invasive ventilation or high flow oxygen devices
- Evidence of pneumonia (pulmonary infiltrates) at chest radiography or computed tomography compatible with COVID-19.
- Hospitalization for less than 72 hours, receiving standard of care treatment for COVID-19.
- Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR).
- Subject (or legally authorized representative) provides written or oral informed consent prior to initiation of any 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
- Subjects on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.
- Inability to provide informed consent (from subject or legally authorized representative) or to comply with test requirements.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Pregnancy or breast feeding.
- Subject participating in another study with for an investigational treatment.
- Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19), that may increase the risk for the study participant based on investigator judgement.
- Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (e.g., azathioprine, cyclosporine).
- Patients with estimated discharge or transfer for other hospital in the first 72 hours of study inclusion.
- Patients with low probability of survival in the first 48 hours of study inclusion.
Key Trial Info
Start Date :
September 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT04901676
Start Date
September 9 2021
End Date
February 1 2023
Last Update
April 15 2022
Active Locations (27)
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1
Hospital Vitoria
Vitória, Espírito Santo, Brazil
2
Clinica São Roque
Ipiaú, Estado de Bahia, Brazil
3
Instituto de Ensino e Pesquisa do Hospital da Bahia
Salvador, Estado de Bahia, Brazil
4
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel
Salvador, Estado de Bahia, Brazil