Poractant Alfa - Curosurf and SARS-COV-19 ARDS (Covid-19)

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase II -Proof of Concept study is to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in adult hospitalized patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Poractant alfa

Criteria

Inclusion Criteria:

Participants are eligible to be included in the study if the following criteria apply:

1. Male or female ≥18 and ≤ 80 years of age

2. Informed consent for participation in the study (refer to section 15 for detailed inform consent procedure)

3. Positive 2019-nCoV rt-PCR before randomisation

4. PaO2/FiO2 ratio < 150 mmHg

5. Lung compliance ≤45 ml/cmH20

6. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage and pneumothorax)

2. Weight < 40kg

3. Stage 4 severe chronic kidney disease (i.e., eGFR < 30)

4. Pregnancy

5. Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration