COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05184101

Frank MP van Haren, PhD

frank.vanharen@anu.edu.au

2022-01-11

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age 18 years or older currently admitted to hospital there is a positive sample for covid-19 within the past 14 days. the sample can be a nasal or pharyngeal swab, sputum, tracheal aspirate, bronchoalveolar lavage, or another sample from the patient requiring oxygenation according to the modified ordinal clinical scale 4-5

intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinician's assessment heparin allergy or heparin-induced thrombocytopaenia activated partial thromboplastin time (aptt) > 120 seconds, not due to anticoagulant therapy and does not correct with administration of fresh frozen plasma platelet count < 20 x 10^9 per l within 48 hours of randomisation pulmonary bleeding or uncontrolled bleeding within 48 hours of randomisation known or suspected pregnancy 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 hours clinician objection participant consent declined

2

Australian National University

18

100

Australia

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

Intubation

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "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"}]