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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22695

Enrollment

124

Registered

2020-05-02

Start date

2020-07-13

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

All COVID-19 patients with an indication for admittance to the ICU department will be included and will (after informed consent) be rondomised to receive a bolus of alkaline phosphatase of 1000iU, fol

Eligibility

Inclusion criteria

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 60% - Clinical evidence of respiratory distress (RR > 25 breaths/minute) - Respiratory acidosis (pH< 7.35)

Exclusion criteria

Exclusion criteria: - Inclusion in another interventional clinical trial - 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

Design outcomes

Primary

Measure	Time frame
Duration of mechanical ventilation	—

Secondary

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

Contacts

Public Contactstephan papendorp

RKZ

spapendorp@rkz.nl0251-265976

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)