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Countering Lung Damage in COVID-19 infection (CounterCovid) study

Countering Lung Damage in COVID-19 infection (CounterCovid) study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23447
Enrollment
386
Registered
2020-03-31
Start date
2020-03-31
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19 positive pneumonitis with need for hospital admission

Interventions

Imatinib or placebo

Sponsors

Amsterdam UMC
Lead Sponsor

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

MeasureTime frame
time to liberation from ventilation and supplemental oxygen and alive during a 28day period after randomization

Secondary

MeasureTime 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

Public ContactHarm Jan Bogaard

Amsterdam UMC, location VUmc

hj.bogaard@amsterdamumc.nl+31020 444 1896

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)