Nebulized Heparin for the Treatment of COVID-19

• Status: Completed
• Trial end date: 2021-08-23
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, placebo controlled study to determine if nebulized heparin may reduce the need for mechanical ventilation in hospitalized patients with the novel coronavirus, also known as COVID-19. This will be a part of a larger meta-trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frederick Health
• Treatments: Heparin

Criteria

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

Exclusion Criteria:

• 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