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Nebulized Heparin for the Treatment of COVID-19 (INHALE-HEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723563
Recruitment Status : Enrolling by invitation
First Posted : January 25, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Smoot, PharmD, Frederick Health

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 will be a part of a larger meta-trial.

Condition or disease Intervention/treatment Phase
Covid19 Pneumonia, Viral Drug: Heparin Drug: 0.9%sodium chloride Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INHALEd Unfractionated HEParin for the Treatment of Hospitalized Patients With COVID-19 Pneumonia
Actual Study Start Date : February 22, 2021
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 29, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nebulized Heparin
Heparin 5,000 units/mL Dose: 25,000 units Frequency: Four times per day Duration: until hospital discharge
Drug: Heparin
25,000 units of unfractionated heparin nebulized 4 times daily for the duration of hospitalization

Placebo Comparator: Placebo
0.9% Sodium Chloride Dose: 5 mL Frequency: Four times per day Duration: until hospital discharge
Drug: 0.9%sodium chloride
5 mL of 0.9% sodium chloride nebulized 4 times daily for the duration of hospitalization
Other Name: Placebo




Primary Outcome Measures :
  1. Need for mechanical ventilation at day 28 [ Time Frame: 28 days ]
    proportion of patients needed mechanical ventilation by day 28


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 60 days ]
    Days of hospital admission

  2. Average daily SaO2/FiO2 [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723563


Locations
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United States, Maryland
Frederick Health Hospital
Frederick, Maryland, United States, 21701
Sponsors and Collaborators
Frederick Health
Publications:

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Responsible Party: Thomas Smoot, PharmD, Primary Investigator, Frederick Health
ClinicalTrials.gov Identifier: NCT04723563    
Other Study ID Numbers: FHHep2121
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Thomas Smoot, PharmD, Frederick Health:
heparin
COVID-19
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action