Trial to be conducted in more sites, with drug known to both patient and Investigator, in which patients will be assigned randomly to receive the drug or not in order to assess the efficacy and tolerability of the drug (porcine surfactant, Curosurf®) in hospitalized patients with SARS-COV-19 (COVID-19 INFECTION) acute respiratory distress syndrome
- Conditions
- patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-002632-75-GB
- Lead Sponsor
- CHIESI FARMACEUTICI S.p.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 85
1. Male or female =18 and = 80 years of age
2. Informed consent for participation in the study (refer to section 15 for detailed informed 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*
*[Criterion not applicable to the ECMO additional cohort]
Additional inclusion criterion for ECMO-cohort:
7. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration
OR
8. Supported with vvECMO less than 48 hours before
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1. Any contraindications to surfactant administration e.g., pulmonary haemorrhage 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
6. Extracorporeal membrane oxygenation*
* [Exclusion criterion NOT applicable for patients eligible for the ECMO-cohort]
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method