A pilot, open label, phase II clinical trial of nebulised recombinant tissue-Plasminogen Activator (rtPA)in patients with COVID-19 ARDS: The Plasminogen Activator COVID-19 ARDS (PACA) trial - Nebulised rtPA for ARDS due to COVID-19 – The PACA trial

niversity College London0 个研究点目标入组 36 人开始时间: 2020年4月9日最近更新: 2020年9月28日

适应症

试验速览

暂无简介。

•All treatment group patients must meet the following criteria (ward or ICU based):
•1.Patients with COVID-19 (confirmed by PCR or radiologically)
•2.=16 years
•3.Willing and able to provide written informed consent or where patient doesn’t have capacity, consent obtained from a legal representative
•4.Patients on IMV must meet both the following criteria:
•a.PaO2/FiO2 of = 300
•b.Intubated > 6 hrs
•5.Patients not intubated must meet all the following criteria:
•a.PaO2/FiO2 = 300 or equivalent imputed by non-linear calculation from SpO2/FiO2 (see look-up table in appendices)
•b.In-patient >6hours and being actively treated
•c.On support with non-invasive ventilation OR continuous positive airway pressure (CPAP) OR high flow OR standard oxygen therapy
•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 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•None of the following criteria must apply:
•1.Females who are pregnant
•2.Concurrent involvement in another experimental investigational medicinal product
•3.Known allergies to the IMP or excipients of IMP
•4.A pre-existing bleeding disorder with no definitive treatment (e.g. severe haemophilia)
•5.Pre-existing severe cardiopulmonary disease (e.g. incurable lung cancer, severe chronic obstructive lung disease, cardiomyopathy, heart failure or impaired contractility 6.Fibrinogen < 2.0 g/L at time of screening
•7.Patients considered inappropriate for active treatment (e.g. being considered for palliative care)
•8.Patients with active bleeding in the preceding 7 days
•9.Patients who in the opinion of the investigator are not suitable

发起方

niversity College London