CTRI/2020/11/029175.

Study name	Role of heparin inhalation in reducing the duration the patient is breathing with the help of a ventilator
Starting date	17 November 2020
Contact information	Shagufta Naaz    Associate professor, department of Anaesthesiology, AIIMS Patna, Phulwarisharif Patna 801507 801507 Kancheepuram, BIHAR India 07765937919 | drshaguftanaaz@gmail.com
Methods	Interventional, RCT, 1:1, active controlled trial, participant blinded
Participants	58 participants, ≥ 18 years, female and male Inclusion criteria: Confirmed COVID‐19 Endotracheal tube in place Intubated the day before or same day PaO2 to FIO2 ratio ≤ 300 while intubated Acute opacities not fully explained by effusions, lobar/lung collapse and nodules, affecting at least one lung quadrant on chest X‐ray or CT Currently in the ICU or scheduled for transfer to the ICU Exclusion criteria: Enrolled in another clinical trial that is unapproved for co‐enrolment Heparin allergy or HIT aPTT > 120 s and this is not due to anticoagulant therapy Platelet count < 20 x 109/L Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with repeated haemoptysis or requiring repeated suctioning Uncontrolled bleeding Pregnant or might be pregnant Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain‐Barre syndrome Usually receives home oxygen Death is imminent or inevitable within 24 h
Interventions	Experimental: Heparin nebulization plus standard care: each participant will be assigned to nebulised heparin sodium 25,000 Units in 5 mL or an equivalent unfractionated heparin, the frequency being 6‐hourly till extubation or up to 10 days whichever is earlier Comparator: Standard care: each participant will be assigned to standard care. They will not be nebulized with heparin
Outcomes	Primary The primary outcome is the time to separation from mechanical ventilation (duration of mechanical ventilation) up to day 28. Time point: up to day 28 Secondary Change in oxygenation index, driving pressure and ventilatory ratio at day 2 Change in white cell count, platelet count, C‐reactive protein, D‐dimer and INR to day 10 Number tracheotomised to day 28 Time to separation from the ICU to day 28, among survivors Survival to day 28; survival to day 60; and survival to hospital discharge, censored at day 60 Number residing at home or in a community setting at day 60, among survivors Time point: the time to separation from mechanical ventilation (duration of mechanical ventilation) up to day 10 or 28 or 60 days as applicable
Notes	CTRI/2020/11/029175 | No data provided | Source(s) of monetary support: AIIMS Patna