Safety use of Liraglutide in patients with Covid19 pneumonia
Phase 2
- Conditions
- Hospitalized patients for Covid-19 pneumonia
- Registration Number
- RBR-8vyvnmb
- Lead Sponsor
- niversidade Federal de São Paulo - Disciplina de Pneumologia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Aged over 18 years old; Covid19 pneumonia admitted to hospital less than forty-eight hours including those within a critical care setting
Exclusion Criteria
Anticipated eligibility for extracorporeal membrane oxigenation support in subsequent 72h; life expectancy less than 48h estimated by one or members of the clinical team; impaired liver function, defined as alanine aminotransferase more than 3 times the upper limit of normal; impaired renal function, defined as an estimated glomerular filtration rate less than 30 mL/min/1.73m2; active pancreatitis; known allergy to liraglutide; pregnancy or lactation
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in glycosylated CD147 Day 0 to 5. <br>Glycosylated CD147 (in PBMC) will be assessed by western blotting and FACs. <br>Obs: This exploratory, proof of concept study employs a biomarker endpoint, change in glycosylation of the CD147 receptor. Secondary endpoints will evaluate early efficacy signals with no a priori assumptions around therapeutic effects from the drug. Sample size for this study is based on collection of safety data for use of Liraglutide in patients treated for severe Covid-19 pneumonia in hospital. Endpoints based on therapeutic effect are purely exploratory and have not been taken into account in the design or sample size of this study.<br>
- Secondary Outcome Measures
Name Time Method Change in composite clinical score: lymphocyte count, CRP, BNP, D dimer, A-a gradient, (PaO2/FiO2 ratio) measured Day 0 and Day 5; Requirement for positive pressure support, (duration of mechanical ventilation, ICU length of stay); Change in serum BNP, Troponin, HbA1c, LDH, fibrinogen, C peptide, glucagon, cytokine profiles; Change in LVEF, TAPSE, RV Fractional area change, estimated PASP - assessed on echocardiogram; Change in plasma CD147, MMP9, MMP2 levels. - Plasma CD147, MMP2 e MMP9 níveis de proteína usando kits comerciais no Dia 5 (sistemas de P&D, MN, EUA), perfil de citocinas de soro com a utilização do Proteome Profiler Human Cytokine Array Kit do sistema de P&D. https://www.rndsystems.com/products/proteome-profiler-human-cytokine-array-kit_ary005b (105 citocinas ~513GBP). <br>