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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003505-58-IT

Enrollment

Registered

2020-11-06

Start date

2021-01-07

Completion date

Unknown

Last updated

2023-09-11

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

Conditions

Moderate COVID-19-related pneumonia MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Ciclosporina A liposomiale Product Code: [L-CSA] Pharmaceutical Form: Powder for nebuliser suspension INN or Proposed INN: CICLOSPORINA CAS Number: 59865-13-3 Current Sponsor code: L-CSA

Eligibility

Sex/Gender

All

Inclusion criteria

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 5mg/dl, IL6 levels >40 pg/ml) • Exclusion of coinfection by PTCI =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients aged 0.5 ng/ml • Lymphopenia less than 200/mmc • Hemoglobin 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The safety and a proof of concept of efficacy of the treatment;Secondary Objective: •Survival rate within 8 and 28 days •> than 40% decrease in PaO2/FiO2 ratio •Peripheral capillary oxygen saturation (SpO2) at day 1,2,3,4,5,6,7,14 and 28 •PaO2 at day 1,2,4,6,7 and 10 •Admission to the ICU •Length of hospital stay •Re-admission within 28 days •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	—

Measure

Time frame

Main Objective: The safety and a proof of concept of efficacy of the treatment;Secondary Objective: •Survival rate within 8 and 28 days •> than 40% decrease in PaO2/FiO2 ratio •Peripheral capillary oxygen saturation (SpO2) at day 1,2,3,4,5,6,7,14 and 28 •PaO2 at day 1,2,4,6,7 and 10 •Admission to the ICU •Length of hospital stay •Re-admission within 28 days •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

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Countries

Italy

Contacts

Public ContactPneumologia

Fondazione IRCCS Policlinico San Matteo

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026