COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49022

Shagufta Naaz

drshaguftanaaz@gmail.com

2020-11-17

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Confirmed COVID-19, Endotracheal tube in place, Intubated the day before or same day, PaO2 to FIO2 ratio less than or equal to 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. <br/ >

Enrolled in another clinical trial that is unapproved for co-enrolment, Heparin allergy or HIT, APTT > 120 seconds and this is not due to anticoagulant therapy, Platelet count < 20 x 109 per 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 hours <br/ >

2

AIIMS Patna

18

55

India

Critical disease at enrollment

8: Critical disease at enrollment

58

The primary outcome is the time to separation from mechanical ventilation (duration of mechanical ventilation) upto day 28Timepoint: The primary outcome is the time to separation from mechanical ventilation (duration of mechanical ventilation) upto day 28

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 873, "treatment_name": "Nebulised unfractionated heparin (ufh)", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]