Safety use of Liraglutide in patients with Covid19 pneumonia

Use of Liraglutide to treat Covid19 pneumonia: A Phase II open-label, single center safety study with biomarker profiling

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-8vyvnmb

Enrollment

Unknown

Registered

2020-12-09

Start date

2020-12-15

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Hospitalized patients for Covid-19 pneumonia

Interventions

Early use of liraglutide for COVID19 pneumonia. 12 patients will be included for the use of Liraglutide 0.6mg subcutaneous injection once daily for 5 days, without a control group, to assess the respo

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Eligibility

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in glycosylated CD147 Day 0 to 5. Glycosylated CD147 (in PBMC) will be assessed by western blotting and FACs. 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.	—

Measure

Time frame

Change in glycosylated CD147 Day 0 to 5. Glycosylated CD147 (in PBMC) will be assessed by western blotting and FACs. 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.

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Brazil

Contacts

Public ContactSEFICE - Disciplina de Pneumologia

secretariapneumologiaunifesp@gmail.com+55 11 55764848 (VOIP 17305)

Outcome results

None listed

Source: REBEC (via WHO ICTRP)