Aerosolized DNase I for the treatment of severe respiratory failure in COVID-19 - a phase 2, randomized controlled trial

Region Skåne0 个研究点目标入组 100 人开始时间: 2020年4月28日最近更新: 2020年6月8日

试验速览

暂无简介。

•1.Age =18 years old.
•2.Admitted to hospital ward or ICU.
•3.A positive PCR test for SARS-CoV-2 from throat swab or nasopharynx.
•4.An oxygen saturation =90% after maximum 15 minutes without supplemental oxygen.
•5.Signed informed consent.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•1.Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation.
•2.Known or suspected allergy against Pulmozyme (dornase alfa).
•3.Chronic obstructive pulmonary disease stage III-IV or another comparable chronic respiratory disease.
•4.Participation in a clinical study with an investigational product during the last 30 days.
•5.Previous participation in this study.
•6.Pregnancy. Women of childbearing potential must agree to use contraceptives for the duration of the study period.
•7.Any condition that, in the opinion of the Investigator, would place the patient at increased risk or preclude the patient’s compliance with the study.

发起方