COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04847375

Ali Dabbagh, MD

alidabbagh@yahoo.com

2021-04-19

Unknown

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: - age over 18 years - definitive proof of covid-19 infection by polymerase chain reaction (pcr) within 48 hours of hospital admission - covid-19 related moderate ards following berlin criteria definition with pao2/fio2 < 200 requiring what condition? - signed and dated informed consent form (icf) by the subject or caregivers

- known or high suspicion of pre-existing heart failure, unstable angina - presence of severe shock with hemodynamic instability despite escalating vasopressors - severe, underlying pulmonary infection or severe pulmonary disease except for covid-19 (copd, pulmonary fibrosis, lung cancer, bacterial pneumonia, etc.) - diagnosis of pulmonary hemorrhage - pregnancy or lactation - other significant cause than ards to the respiratory failure - age less than 18 - age more than 80 - need for ecmo (extracorporeal membrane oxygenation) during the study - anticipated transfer to another hospital within 72 hours - known hypersensitivity to exogenous surfactant - current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes

2

Shahid Beheshti University of Medical Sciences

18

80

None

Severe disease at enrollment

6: Severe disease at enrollment

60

lowest oxygen saturation;rate of ICU admission;rate of tracheal intubation

None

Not reported

[{"arm_notes": "", "treatment_id": 492, "treatment_name": "Exogenous surfactant", "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"}]