COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04901689

Not reported

Not reported

2021-05-25

Suspended

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: male or females aged ≥ 18 years critically ill patients with covid-19 (defined as ordinal scale score of 7): hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo) for less than 72 hours. evidence of pneumonia (pulmonary infiltrates) at chest radiography or computed tomography compatible with 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.

subjects who had been on invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo) for >72 hours prior to the screening. 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.

2

Hospital Israelita Albert Einstein

18

100

Brazil

Critical disease at enrollment

8: Critical disease at enrollment

316

Cumulative proportion of clinical recovery

None

Phase 3

[{"arm_notes": "", "treatment_id": 727, "treatment_name": "Leronlimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]