se of Inhaled liposomal -Cyclosporin-A in the treatment of moderate COVID-19-related pneumonia: a two-step phase II clinical trial

Phase 1

• Conditions: Moderate COVID-19-related pneumonia; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-003505-58-IT
• Lead Sponsor: FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-06
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The safety and a proof of concept of efficacy of the treatment;Secondary Objective: •Survival rate within 8 and 28 days<br>•> than 40% decrease in PaO2/FiO2 ratio<br>•Peripheral capillary oxygen saturation (SpO2) at day 1,2,3,4,5,6,7,14 and 28<br>•PaO2 at day 1,2,4,6,7 and 10<br>•Admission to the ICU<br>•Length of hospital stay<br>•Re-admission within 28 days<br>•The cumulative incidence and severity of adverse events;Primary end point(s): The primary outcome will be safety and response to treatment. A patient is considered responder in the absence of oxygenation impairment (>than 40% decrease in PaO2/FiO2 ratio) within 7 days from enrolment.;Timepoint(s) of evaluation of this end point: 7 days