COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04511923

John Laffey

John.laffey@nuigalway.ie

2020-08-13

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: to be eligible, a patient must satisfy all these inclusion criteria: confirmed or suspected covid-19. note, if 'suspected', results must be pending or testing intended ability to obtain informed consent/assent to participate in study age 18 years or older requiring high flow nasal oxygen or positive pressure ventilator support or invasive mechanical ventilation for a time period of no greater than 48 hours d-dimers > 200 ng/ml pao2 to fio2 ratio less than or equal to 300 acute opacities on chest imaging affecting at least one lung quadrant. note 'acute opacities' do not include effusions, lobar/lung collapse or nodules currently in a higher level of care area designated for inpatient care of patients where therapies including non-positive pressure ventilatory support can be provided. exclusion criteria to be eligible, a patient must have none of these

enrolled in another clinical trial that is unapproved for co-enrolment heparin allergy or heparin-induced thrombocytopaenia aptt > 100 seconds platelet count < 50 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 suspected pregnancy (urine or serum hcg will be recorded) receiving or about to commence ecmo or hfov 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 dependent on others for personal care due to physical or cognitive decline (pre-morbid status) death is imminent or inevitable within 24 hours the clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification clinician objection. the use or anticipated use of nebulised tobramycin during this clinical episode any other specific contraindication to anticoagulation including prophylactic anticoagulation not otherwise listed here relapse in clinical condition in patient that had fully weaned from advanced respiratory support any systemic anticoagulation other than prophylactic anticoagulation

2

University College Hospital Galway

18

100

Ireland

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

40

Frequenccy of Severe Adverse Outcomes;D-dimer profile

None

Phase 1/Phase 2

[{"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"}]