Countering Lung Damage in COVID-19 infection (CounterCovid) study
- Conditions
- Covid19 positive pneumonitis with need for hospital admission
- Registration Number
- NL-OMON23447
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 386
Age >18 years
- Hospital admission with proven SARS2-Covid19 infection
- Hypoxemic respiratory failure (SaO2 <92%, PaO2 <8kPa)
- Ability to give informed consent
1. Pre-existing chronic pulmonary disease, including:
? Known diagnosis of Interstitial Lung disease
? Former diagnosis of COPD 4 or FEV1<30%pred
? DLCO <45%
? Total lung capacity (TLC) < 60% of predicted
? Lung cancer with non-surgical treatment in last year
2. Home oxygen treatment
3. Pre-existing heart failure with a known left ventricular ejection fraction <40%
4. Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy in the last year
4. Inability to provide informed consent
5. Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
6. Active liver disease, porphyria or elevations of serums transaminases >3 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to liberation from ventilation and supplemental oxygen and alive during a 28day period after randomization
- Secondary Outcome Measures
Name Time Method o 28-day mortality<br>o Need for ICU admission<br>o Length of ICU admission<br>o Need for invasive ventilation<br>o Days on ventilator<br>o Need for ECMO<br>o Need for non-invasive ventilation<br>o SpO2 at Day 1,2,3,4,5,8,10<br>o Fi O2 at Day 1,2,3,4,5,8,10<br>o SpO2/FiO2 at Day 1,2,3,4,5,8,10<br>o Viral clearance at Day 5 and 10.<br>o Blood cell count Day 0,1,2,3,5,7,10<br>o Kidney function Day 0,1,2,3,5,7,10<br>o Liver enzymes Day 0,1,2,3,5,7,10<br>o NTproBNP at Day 0,1,2,3,5,7,10<br>o SAEs / AE<br>o ECG at Day 1,3,5,10<br>o Study drug plasma levels at 4h, 8h, Day 1,3,5,7,10<br>o Albumin, AGP1 at Day 0,1,2,3,5,7,10