A proof-of-concept study of the use of Inhaled liposomal -Cyclosporin-A in the treatment of moderate COVID-19-related pneumonia: a two-step phase II clinical trial - INCIPIT

FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO0 个研究点目标入组 31 人开始时间: 2020年11月6日最近更新: 2023年9月11日

适应症

试验速览

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•Ability to obtain informed patient consent noting the limitations of existing knowledge regarding Inhaled Liposomal CSA efficacy and the labeled warning and precautions as the proposed use is outside the approved indication.
•Informed Consent as documented by signature
•Adult patients aged 18-74 years-old
•Bilateral infiltrates at chest radiography
•=48 hours from admission
•Positive Nasal Swab at PCR assay specific for SARS-CoV-2
•Moderate acute respiratory syndrome (SARS)-CoV-2 pneumonia PaO2/FiO2 between 300-200 in FiO2 •Ability to perform 8-13 min aerosolization
•Evidence of clear hyperinflammatory state (CRP >5mg/dl, IL6 levels >40 pg/ml)
•Exclusion of coinfection by PTCI < than 0.5 ng/ml
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients aged < 18 years old and = 75 years old
•Concomitant and documented bacterial infection or PCTI > 0.5 ng/ml
•Lymphopenia less than 200/mmc
•Hemoglobin < 8 g/dl
•Absolute neutrophil count < 1 x 109 cells/L
•PaO2/FiO2 not included in the following interval 300-200 need of a FiO2 support > than 60%
•Treatment with CPAP and /or inability to perform a 10 min aerosolization course
•Sudden clinical deterioration requiring ICU access or palliative care
•Known hypersensitivity or allergy to CSA
•Creatinine clearance < 30 mL/min;
•Severe hepatic impairment
•Pregnant or breast-feeding
•Active tuberculosis
•Evidence of active HBV (HbsAg positive) or with detectable HCV-RNA, HIV

发起方

FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO