A randomized double-blind placebo-controlled, pilot trial of intravenous plasma-purified alpha-1 antitrypsin for severe COVID-19 illness.

Royal College of Surgeons Ireland0 个研究点目标入组 36 人开始时间: 2020年3月31日最近更新: 2021年4月19日

试验速览

暂无简介。

•1.Laboratory confirmed diagnosis of COVID-19 infection
•2. Moderate to severe ARDS with a PaO2/FiO2 ratio <200
•3. >18 years of age
•4. Patients receiving invasive mechanical ventilation or non-invasive ventilation
•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 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•1. Not receiving invasive mechanical ventilation or non invasive ventilation
•2. More than 96 hours from the onset of ARDS
•3. Age < 18 years
•4. Known to be pregnant or breastfeeding
•5. Participation in a clinical trial of interferon therapies, immune plasma therapies or immunoglobulin within 30 days
•6. Major trauma in the prior 5 days
•7. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year
•8. WHO Class III or IV pulmonary hypertension
•9. Pulmonary embolism within past 3 months
•10. Currently receiving extracorporeal life support (ECLS)
•11. Currently receiving renal replacement therapy
•12. Severe chronic liver disease with Child-Pugh score > 12
•13. DNAR (Do Not Attempt Resuscitation) order in place
•14. Treatment withdrawal imminent within 24 hours
•15. Prisoners
•16. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available.
•17. Enrolled in a concomitant clinical trial of interferon therapies, immune plasma therapies or immunoglobulin.
•18. IgA deficiency

发起方

Royal College of Surgeons Ireland