Nebulized Heparin for the Treatment of COVID-19

Completed · Phase 4 · Has a placebo group

Conditions studied: Covid19, Pneumonia, Viral

In brief

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.

Key facts

Study ID: NCT04723563
Run by: Frederick Health
People needed: 50
Starts: 2021-02-22
Expected to finish: 2021-08-23
Last updated by the study team: 2021-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Frederick Health Hospital — Frederick, Maryland, United States

Full record on ClinicalTrials.gov

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