Covid19 positive pneumonitis with need for hospital admission
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age >18 years - Hospital admission with proven SARS2-Covid19 infection - Hypoxemic respiratory failure (SaO2 <92%, PaO2 <8kPa) - Ability to give informed consent
Exclusion criteria
Exclusion criteria: 1. Pre-existing chronic pulmonary disease, including: ? Known diagnosis of Interstitial Lung disease ? Former diagnosis of COPD 4 or FEV13 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN 7. History or suspicion of inability to cooperate adequately. 8. White blood count < 4.0^109/l 9. Hemoglobin < 6.0 mmol/l 10. Thrombocytes < 100^109/l 11. Pregnant female subjects 12. Breastfeeding female subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to liberation from ventilation and supplemental oxygen and alive during a 28day period after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| o 28-day mortality o Need for ICU admission o Length of ICU admission o Need for invasive ventilation o Days on ventilator o Need for ECMO o Need for non-invasive ventilation o SpO2 at Day 1,2,3,4,5,8,10 o Fi O2 at Day 1,2,3,4,5,8,10 o SpO2/FiO2 at Day 1,2,3,4,5,8,10 o Viral clearance at Day 5 and 10. o Blood cell count Day 0,1,2,3,5,7,10 o Kidney function Day 0,1,2,3,5,7,10 o Liver enzymes Day 0,1,2,3,5,7,10 o NTproBNP at Day 0,1,2,3,5,7,10 o SAEs / AE o ECG at Day 1,3,5,10 o Study drug plasma levels at 4h, 8h, Day 1,3,5,7,10 o Albumin, AGP1 at Day 0,1,2,3,5,7,10 | — |
Contacts
Amsterdam UMC, location VUmc