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

Conditions: COVID-19

Registration Number: NL-OMON22695

Lead Sponsor: Rode Kruis ziekenhuis Beverwijk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 124

Inclusion Criteria

Patients with proved or considered Sars-CoV-2 infection admitted to the ICU with type 1 or 2 respiratory failure despite supplemental oxygen.

Sars-CoV-2 infection based on: highly clinical suspicion on admission and/or positive PCR test on nasopharynx 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 < 60 mmHg despite FiO2 >60%
- Clinical evidence of respiratory distress (RR > 25 breaths/minute)
- Respiratory acidosis (pH< 7.35)

Exclusion Criteria

- 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 medical treatment with immunosuppressive effects
- Patients with active haematological malignancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
(1) ICU Mortality<br>(2) Number (%) of patients with acute kidney injury (AKI) stage 2/3 (KDIGO criteria)<br>(3) Number (%) of ventilated patients<br>(4) Number (%) of patients in need for reintubation<br>(5) Safety (according to chapter 8)<br>(6) Values of inflammatory markers (e.g. macrophages, neutrophils, lymphocytes and their inflammatory products (TNF-a, IL-6, IL-8, IL-10))