Status:
COMPLETED
Nebulized Heparin for the Treatment of COVID-19
Lead Sponsor:
Frederick Health
Conditions:
Covid19
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
COVID-19 is a novel coronavirus that can cause severe and potentially fatal respiratory infections. COVID-19 has many similarities to previously seen coronaviruses, such as those that caused the Middl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04723563
Start Date
February 22 2021
End Date
August 23 2021
Last Update
September 5 2021
Active Locations (1)
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1
Frederick Health Hospital
Frederick, Maryland, United States, 21701