A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFMSTT1041A OR UTTR1147A IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA - COVASTI

Genentech, Inc.0 个研究点目标入组 300 人开始时间: 2020年7月20日最近更新: 2021年3月22日

适应症

试验速览

暂无简介。

•Age >=18 years
•Hospitalized with COVID-19 pneumonia confirmed per WHO criteria and evidenced by chest X-ray or CT scan
•Peripheral capillary oxygen saturation (SpO2) <= 93% or partial pressure of oxygen/fraction of inspired oxygen <= 300 mmHg or requiring supplemental oxygen to maintain SpO2 > 93%
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 195
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 105

•Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
•In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
•Participating in another clinical drug trial
•Treatment with investigational therapy (other than for COVID-19) within 5 half-lives or 30 days prior to initiation of study drug
•Use of Janus kinase inhibitor within 30 days or 5 drug elimination half-lives prior to screening
•Have received high-dose systemic corticosteroids within 72 hours prior to Day 1
•Known HIV infection with CD4< 200 cells/micro liter or <14% of all lymphocytes
•Alanine aminotransferase and aspartate aminotransferase >10× upper limit of normal (ULN) detected at screening
•History of anaplastic large-cell lymphoma or mantle-cell lymphoma
•History of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment
•Clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure) as assessed by the investigator assessment, ECG, laboratory assessment, or echocardiographic data
•History of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment

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