NCT04397510.

Study name	Nebulized heparin vs. placebo for the treatment of COVID‐19 induced lung injury
Starting date	1 June 2020
Contact information	Thomas Smoot Frederick Health Hospital, Frederick, Maryland, USA
Methods	Multicentre, single‐masking (outcomes assessor), investigator‐sponsored, 2‐armed, parallel‐assignment RCT
Participants	50 participants, ≥ 18 years, female and male Inclusion criteria Age ≥ 18 years Admitted to the ICU Positive COVID‐19 PCR Mechanical ventilation for ≤ 48 h PaO2/FiO2 ≤ 300 Exclusion criteria Heparin allergy Active bleeding Death or withdrawal of care anticipated by intensivist within 24 h Platelets < 50,000 cells/µL Clinically significant coagulopathy, as decided by the intensivist O2‐dependent at baseline
Interventions	Experimental: nebulised heparin 5000 units/mL IV formulation diluted with 3 mL of 0.9% sodium chloride. Dose: 10,000 units. Frequency: every 4 h. Duration: 10 days Comparator: placebo. 0.9% sodium chloride. Dose: 5 mL. Frequency: every 4 h. Duration: 10 days
Outcomes	Primary Mean daily PaO2 to FiO2 ratio (time frame: 10 days) Secondary Duration of mechanical ventilation (time frame: 30 days) ICU length of stay (time frame: 30 days) Mortality rate (time frame: 30 days) Incidence of adverse drug events (time frame: 10 days)
Notes	NCT04397510 | FHHep518 | No data provided