A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group,group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for thetreatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 200 人2021年4月6日

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简要总结

暂无简介。

注册库

who.int

开始日期

2021年4月6日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Boehringer Ingelheim Pharma GmbH & Co. KG

入排标准

入选标准

•1\. \= 18 years old, males and females.
•2\. Signed and dated written informed consent in accordance with ICH\-GCP and local legislation prior to admission to the trial.
•3\. Documentation of laboratory\-confirmed SARS\-CoV\-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (NP or nasal swab or saliva) collected no more than 72 hours prior to start of treatment.
•4\. Patients experienced mild to moderate COVID\-19\-related symptoms or measured fever for no more than 5 days prior to start of treatment where symptoms are defined by fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia.
•5\. One or more of the following signs/symptoms present on day of start of treatment: fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia.
•6\. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2\) that result in a low failure rate of less than 1% per year when used consistently and correctly.
•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 65

排除标准

•1\. Body weight of less than 40 kg.
•2\. Severe or critical COVID\-19 including at least one of:
•o Oxygen saturation (SpO2\) \= 93 % on room air or on their usual level of oxygen supplementation in case of chronic oxygen use
•o Ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2\) \< 300 (in case arterial blood sample was taken)
•o Respiratory rate \= 30/min or heart rate \= 125/min. Measure should be obtained at rest by study staff within 24 hours of start of treatment.
•o History of hospitalization for COVID\-19
•o Current or imminent need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. Does not include patients hospitalized for isolation only.
•3\. Receipt of intraveneous immunoglobulin within 12 weeks prior to Visit number 2\.
•4\. Receipt of COVID\-19 convalescent plasma treatment at any time prior to Visit 2\.
•5\. Receipt of any SARS\-CoV\-2 monoclonal antibody treatment at any time prior to Visit 2\.