A pilot, open-label, randomised controlled clinical trial to investigate early efficacy of CYP-001 in adults admitted to intensive care with respiratory failure (due to COVID-19 or another underlying condition).

Cynata Therapeutics Limited0 个研究点目标入组 14 人开始时间: 2020年5月25日最近更新: 2023年4月17日

适应症

试验速览

暂无简介。

•1. Male or female, 18 years of age or older
•2. Respiratory failure with the following signs and symptoms:
•P/F ratio <300 mmHg
•Onset within one week of insult or new or worsening respiratory symptoms.
•Chest imaging shows bilateral opacities, which are not fully explained by effusions,
•lobar/lung collapse, or nodules.
•3. Respiratory failure which is not fully explained by cardiac failure or fluid overload.
•4. Onset of respiratory failure (as defined in inclusion criterion 2) within the past 48 hours.

•1. <18 years of age
•2. Patient is known to be pregnant
•3. Known active malignancy that required treatment in the last year
•4. WHO (2019) Class III, IV or V pulmonary hypertension
•5. Venous thromboembolism currently receiving anti-coagulation or within the past 3 months
•6. Currently receiving extracorporeal life support
•7. Severe chronic liver disease (Child-Pugh score >12)
•8. Do Not Attempt Resuscitation” order in place
•9. Treatment withdrawal imminent within 24 hours
•10. BMI > 45 kg/m2.
•11. Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment.
•12. Known positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus, Hepatitis C virus or any other infection which the opinion of the Investigator is likely to impact on the ability of the patient to participate in the study.
•13. Known sensitivity to DMSO or any other component of the study treatments.

发起方