NCT04723563.

Study name	Inhaled unfractionated heparin for the treatment of hospitalized patients with COVID‐19 pneumonia
Starting date	21 February 2021
Contact information	Thomas Smoot, PharmD Frederick Health Hospital Frederick, Maryland, USA, 21701
Methods	Quadruple‐blind, parallel‐assignment RCT
Participants	50 participants, ≥ 18 years, female and male Inclusion criteria: Admitted to the hospital There is a PCR‐positive sample for SARS‐CoV‐2 within the past 21 days. The sample can be a nasal oropharyngeal swab, sputum, tracheal aspirate, bronchoalveolar lavage, or another sample from the patient Modified Ordinal Clinical Scale for COVID‐19 of 3‐5 Exclusion criteria: Intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinician's assessment Heparin allergy or HIT aPTT > 120 seconds, not due to anticoagulant therapy and does not correct with administration of fresh frozen plasma Platelet count < 20 x 109/L Pulmonary bleeding or uncontrolled bleeding Pregnant or might be pregnant Acute brain injury that may result in long‐term disability Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain‐Barre syndrome Treatment limitations in place, i.e. not for intubation, not for ICU admission Death is imminent or inevitable within 24 h Clinician objection Refusal of participant (person responsible) consent
Interventions	Experimental: nebulised heparin Heparin 5000 units/mL. Dose: 25,000 units. Frequency: 4 times/day. Duration: until hospital discharge Comparator: placebo 0.9% sodium chloride. Dose: 5 mL. Frequency: 4 times/day. Duration: until hospital discharge
Outcomes	Primary Need for mechanical ventilation at day 28 (time frame: 28 days) Secondary Hospital length of stay (time frame: 60 days) Average daily SaO2/FiO2 (time frame: 28 days)
Notes	NCT04723563 | No data provided