Alkaline phosphatase for reducing systemic inflammatory response syndrome (SIRS) in patients with Sars-CoV-2 infection and acute respiratory insufficiency (COVID 19) - COVID-RESCAP

Red Cross Hospital Beverwijk0 个研究点目标入组 106 人开始时间: 2020年11月8日最近更新: 2021年3月8日

适应症

试验速览

暂无简介。

•-Sars-CoV-2 infection based on: highly clinical suspicion on admission and/or positive PCR test on naso¬pharynx swab or sputum and/or a CT imaging of the chest compatible with COVID-19 + type 1 or type 2 respiratory failure despite supplemental oxygen that indicates airway support/ICU admittance and meeting any of the following criteria: .
•-SpO2 <90% or PaO2/FiO2 < 200 mmHg
•-Clinical evidence of respiratory distress (RR > 25 breaths/minute)
•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 17
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 115

•-Inclusion in another interventional clinical trial
•-Age < 18
•-Age > 80
•-Patients who are pregnant or lactating
•-Patients expected to have fatal disease within 24 hours
•-Patients who are already on dialysis (Renal Replacement Therapy, RRT) or a decision has been made to initiate RRT within 24 hours after planned start of study drug administration
•-Patients who have advanced chronic liver disease confirmed by a Child-Pugh C
•-Patients who are having an known history of immune system that has been impaired by disease, such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (<0.5 x 109/l) or patients who are receiving chronic high doses (equivalent to prednisone/prednisolone 0.5 mg/kg/day) steroids therapy immediately prior to recruitment exceeding 2 weeks of treatment. This means dexamethasone 6 mg once daily serving as treatment for severe COVID-19 is not an exclusion criteria.
•-Patients with active haematological malignancy

发起方

Red Cross Hospital Beverwijk