COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04502433

Clark Howard

Not reported

2020-08-06

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: participants were eligible to be included in the study if the following criteria apply: male or female ≥18 and ≤ 80 years of age informed consent for participation in the study (refer to section 15 for detailed inform consent procedure) positive 2019-ncov reverse transcription polymerase chain reaction (rt-pcr) before randomisation arterial partial pressure of oxygen/fraction of inspired oxygen (pao2/fio2) ratio < 150 mmhg lung compliance ≤45 ml/cmh20 intubated and artificially ventilated less than 48 hours before the first poractant alfa administration

participants were excluded from the study if any of the following criteria apply: any contraindications to surfactant administration e.g., pulmonary hemorrhage and pneumothorax) weight < 40kg stage 4 severe chronic kidney disease (i.e., estimated glomerular filtration rate (egfr) < 30) pregnancy administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration extracorporeal membrane oxygenation (ecmo)

2

Chiesi Farmaceutici S.p.A.

18

80

Italy;United Kingdom;United States

Critical disease at enrollment

8: Critical disease at enrollment

22

Number of days alive and ventilator-free days

None

Phase 2

[{"arm_notes": "", "treatment_id": 1011, "treatment_name": "Poractant alfa", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]