COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04723563

Thomas L Smoot, PharmD

TLSmoot@frederick.health

2021-01-25

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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 orpharyngeal swab, sputum, tracheal aspirate, bronchoalveolar lavage, or another sample from the patient - modified ordinal clinical scale for covid-19 of 3-5

- intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinician's assessment - heparin allergy or heparin-induced thrombocytopaenia - aptt > 120 seconds, not due to anticoagulant therapy and does not correct with administration of fresh frozen plasma - platelet count < 20 x 109 per 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 hours - clinician objection - refusal of participant (person responsible) consent

2

Frederick Health

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

50

Need for mechanical ventilation at day 28

None

Phase 4

[{"arm_notes": "Nebulized heparin", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]