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

Phase 2

Completed

• Conditions: COVID 19 and coronavirus; 10047438; 10037454

• Registration Number: NL-OMON54916
• Lead Sponsor: Rode Kruis Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

- 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 needing
supplemental oxygen that indicates airway support or 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)

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 a 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) 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 criterion.
- Patients with active haematological malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Duration of mechanical ventilation (days) and withholding of mechanical<br /><br>ventilation (%) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- not applicable -</p><br>