EUCTR2020-003278-37-GR进行中（未招募）1 期
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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years;
- •2. Informed consent by the patient or the patient’s legally-authorized representative
- •3. SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing
- •within 3 days prior to randomization OR documented by NAT or equivalent testing more
- •than 3 days prior to randomization AND progressive disease suggestive of ongoing
- •SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those
- •deemed with equivalent specificity to NAT by the protocol team will be allowed. A
- •central list of allowed non-NAT tests will be maintained.);
- •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
- •For participants whose 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 acquisition. The consent form signed
- •by the LAR should reflect that such consent should be obtained.
- •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 2500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2500
排除标准
- •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 hospitalisation;
- •2. Not willing to abstain from participation in other COVID-19 treatment trials until after Day
- •5 (with the approval of study leadership, enrollment before or on Day 5 is permitted for
- •trials comparing different approaches for implementing SOC interventions that are
- •recommended in a)i)(1)(a)(i)Appendix I );
- •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 acknowledge the strong advice to abstain from sexual intercourse with
- •men or practice appropriate contraception through 18 months of the study.
- •6. Men who are unwilling to acknowledge the strong advice to abstain from sexual
- •intercourse with women of child-bearing potential or to use barrier contraception through
- •18 months of the study.
- •Prior to the initial futility assessment for an investigational agent, the following two
- •additional exclusions (7 and 8) which define disease severity stratum 2 apply:
- •7. Presence at enrollment of any of the following:
- •b. meningitis
- •c. encephalitis
- •d. myelitis
- •e. myocardial infarction
- •f. myocarditis
- •g. pericarditis
- •h. symptomatic CHF (NYHA class III-IV)
- •i. arterial or deep venous thrombosis or pulmonary embolism
- •8. Current 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).
- •Women who are pregnant or breastfeeding
研究者
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