COVID 19 MedDRA version: 20.0 Level: LLT Classification code 10062357 Term: SIRS System Organ Class: 100000004867
Conditions
Interventions
Product Name: Alkaline Phosphatase (RESCAP®)
Product Code: EC 3.1.3.1 , CAS-Nummer: 9001-78-9
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: bovine alkaline phosphatas
CAS N
Sponsors
Jessa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 despite supplemental oxygen that indicates airway support/ICU admittance and meeting any of the following criteria: . - SpO2 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and preliminary efficacy of AP in reducing the inflammatory reaction in COVID-19 patients and thereby shorten time on mechanical ventilation or prevent the need for mechanical ventilation in COVID-19 patients. Secondary Objective(s): To reduce mortality rates and prevent acute kidney injury (AKI) stage 2/3 (KDIGO criteria). ;Secondary Objective: Not applicable;Primary end point(s): (1)Duration of mechanical ventilation and withholding of mechanical ventilation (2)ICU mortality (3)Number (%) of patients with acute kidney injury (AKI) stage 2/3 (KDIGO) (4)Concentration of pro-inflammatory cytokines ;Timepoint(s) of evaluation of this end point: discharge from the hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (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)) ;Timepoint(s) of evaluation of this end point: discharge from the hospital | — |
Countries
Belgium, Netherlands
Contacts
Public ContactContract Research Organisation
Aix Scientifics
Outcome results
None listed