A Multicentre, Adaptive, Randomised, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeuticsfor Hospitalised Patients with COVID-19Short Title: Therapeutics for Inpatients with COVID-19 (TICO)INSIGHT Protocol Number: 014 / ACTIV-3 - Therapeutics for Inpatients with COVID-19 (TICO)

Reagents of the University of Minnesota0 个研究点目标入组 1,000 人开始时间: 2020年8月14日最近更新: 2020年10月6日

试验速览

暂无简介。

•1.Age = 18 years;
•2.Informed consent by the patient or the patient’s legally-authorized representative (LAR)*
•3.SARS-CoV-2 infection, documented by PCR or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator;
•4.Duration of symptoms attributable to COVID-19 = 12 days per the responsible investigator;
•5.Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.
•*Continuing consent
•Participants for whom consent was initially obtained from a LAR, but who subsequently regain decision-making capacity while in hospital will be approached for consent for continuing participation, including continuance of data collection.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 500

•1.Prior receipt of any SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19 or any SARS-CoV-2 nMAb at any time prior to hospitalization;
•2.Not willing to abstain from participation in other COVID-19 treatment trials until after Day 5;
•3.In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments;
•4.Expected inability to participate in study procedures;
•5.Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through Day 90 of the study.
•6.Men who are unwilling to abstain from sexual intercourse with women of child-bearing potential or who are unwilling to use barrier contraception through Day 90 of the study.
•7.stage 1 only]
•Presence at enrollment of any of the following:
•b.meningitis
•c.encephalitis
•e.myocardial infarction
•f.myocarditis
•g.pericarditis
•h.symptomatic congestive heart failure (NYHA class III-IV)
•i.arterial or deep venous thrombosis or pulmonary embolism
•8.stage 1 only
•Current or imminent requirement for any of the following:
•a.invasive mechanical ventilation
•c.mechanical circulatory support
•d.vasopressor therapy
•e.commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).

发起方

Reagents of the University of Minnesota