COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001714-38/NL

Aix Scientifics - Contract Research Organisation

eike@aix-scientifics.com

2020-11-08

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

- 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 <90% or PaO2/FiO2 < 200 mmHg - Clinical evidence of respiratory distress (RR > 25 breaths/minute)

- 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 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

2

Red Cross Hospital Beverwijk

18

80

Netherlands

Severe disease at enrollment

6: Severe disease at enrollment

106

(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

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 58, "treatment_name": "Alkaline phosphatase", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]