TOGETHER 3 Trial: An Adaptive Randomized Platform Trial to Investigate the Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults. COVID-19

Cytel Inc0 个研究点目标入组 420 人开始时间: 2020年7月7日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Participants are eligible to be included in the study only if all of the following criteria apply:
•High-risk cohort:
•1.Men or women 18-80 years, inclusive, at the time of signing the informed consent
•2.Willing and able to provide informed consent
•3.Laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
•4.At increased risk of developing severe COVID-19 disease (at least one of the following)
•Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, emphysema, or tuberculosis on treatment
•Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment
•Hypertension, requiring at least 1 antihypertensive oral medication for treatment
•Coronary artery disease with history of graft or stent
•Cardiac failure, Class 2 or greater using New York Heart Association functional class
•History of organ or stem cell transplant
•Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus, confirmed malignancy)
•Immunocompromised status due to medication (e.g., persons taking 20 mg or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, or cancer therapies)
•Body mass index = 30 kg/m2

•Participants are excluded from the study if any of the following criteria apply:
•1.Known hypersensitivity to any of the study drugs
•2.Currently hospitalized
•3.Signs of respiratory distress prior to randomization, including respiratory rate >24 per minute and/or SpO2 < 93%
•4.Chronic kidney disease (Stage IV or receiving dialysis)
•5.Known liver disease or cirrhosis
•6.Known personal or family history of long QT syndrome
•7.Taking chronic medications associated with prolonged QT and may induce Torsades de Pointes as per CredibleMeds.org, including certain antipsychotic medications or antidepressants (e.g., citalopram, venlafaxine, and bupropion) and unable to stop during the trial
•8.Baseline QTc interval of > 470 ms in males, and > 480 ms in females if indicated by the safety profile of the investigational product
•9.Potentially clinically significant pharmacokinetic and pharmacodynamic drug interactions as determined by the study clinical pharmacologist*
•10.Currently participating in a clinical trial currently or within 30 days of randomization.

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