A single-site, randomised, controlled, parallel design, open-label investigation of an approved nebulised recombinant human DNase enzyme (dornase alfa) to reduce hyperinflammation in hospitalised participants with COVID-19 (The COVASE trial) - Dornase alfa to reduce hyperinflammation in COVID19 - The COVASE trial

niversity College London0 个研究点目标入组 40 人开始时间: 2020年6月8日最近更新: 2020年6月15日

适应症

试验速览

暂无简介。

•1.Male and female participants, aged = 18 years
•2.Participants who are hospitalised for suspected Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or radiological confirmation
•3.Participants with stable oxygen saturation (>=94%) on supplementary oxygen
•4.CRP >= 30 mg/L
•5.Participants will have given their written informed consent to participate in the study and are able to comply with instructions and nebuliser
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Exclusion criteria
•1.Females who are pregnant, planning pregnancy or breastfeeding
•2.Concurrent and/or recent involvement in other research or use of another experimental investigational medicinal product that is likely to interfere with the study medication within the last 3 months before study enrolment
•3.Serious condition meeting one of the following:
•I.respiratory distress with respiratory rate >=40 breaths/min
•II.oxygen saturation <=93% on high-flow oxygen
•4.Require mechanical invasive or non-invasive ventilation at screening
•5.Concurrent respiratory disease such as asthma, COPD and/or ILD
•6.Any major disorder that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the study participant
•7.Terminal disease and life expectancy <12 months without COVID-19
•8.Known allergies to the dornase alpha and excipients
•9.Participants who are unable to inhale or exhale orally throughout the entire nebulisation period

发起方

niversity College London