Our hypothesis is that critical ill COVID-19 patients suffer more from their own immune response against the virus, than from the viral infection itself. Alkaline phosphatase (RESCAP®) has proven to reduce SIRS reactions by neutralizing the…
ID
Bron
Verkorte titel
Aandoening
COVID-19
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Duration of mechanical ventilation
Achtergrond van het onderzoek
Our hypothesis is that critical ill COVID-19 patients suffer more from their own immune response against the virus, than from the viral infection itself. Alkaline phosphatase (RESCAP®) has proven to reduce SIRS reactions by neutralizing the inflammatory response in various medical conditions, like sepsis induced acute kidney injury and ischemia-reperfusion reactions in cardiothoracic surgery. Furthermore, endogenous alkaline phosphatase (AP) is highly expressed on type II lung alveolar (surfactant producing) cells and is thought to stabilize the alveolar barrier. In acute inflammation, endogenous AP is lost from the cells after binding to its substrate. Replenishing AP might restore the alveolar barrier and combat subsequent SIRS and secondary organ failure.
The objective is 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.
This will be done in a randomised multicentre prospective interventional clinical trial.
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, followed by 9000 iU the same day. For the 3 consecutive days 10.000iU/day on top of regular care.
Main study parameters/endpoints:
(1) Duration 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
Doel van het onderzoek
Our hypothesis is that critical ill COVID-19 patients suffer more from their own immune response against the virus, than from the viral infection itself. Alkaline phosphatase (RESCAP®) has proven to reduce SIRS reactions by neutralizing the inflammatory response in various medical conditions, like sepsis induced acute kidney injury and ischemia-reperfusion reactions in cardiothoracic surgery. Furthermore, endogenous alkaline phosphatase (AP) is highly expressed on type II lung alveolar (surfactant producing) cells and is thought to stabilize the alveolar barrier. In acute inflammation, endogenous AP is lost from the cells after binding to its substrate. Replenishing AP might restore the alveolar barrier and combat subsequent SIRS and secondary organ failure.
Onderzoeksopzet
1 year
Onderzoeksproduct en/of interventie
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, followed by 9000 iU the same day. For the 3 consecutive days 10.000iU/day on top of regular care.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8578 |
| Ander register | METC VUMC : METC2020248 |