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Nebulized Heparin for the Treatment of COVID-19 Induced Lung Injury

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: NCT04397510
Recruitment Status : Enrolling by invitation
First Posted : May 21, 2020
Last Update Posted : June 2, 2020
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 severity of lung injury caused by the novel coronavirus, also known as COVID-19

Condition or disease Intervention/treatment Phase
Covid-19 ARDS, Human Acute Lung Injury 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: Nebulized Heparin vs. Placebo for the Treatment of COVID-19 Induced Lung Injury
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Nebulized Heparin
Heparin 5,000 units/mL IV formulation diluted with 3 mL of 0.9% sodium chloride Dose: 10,000 units Frequency: every 4 hours Duration: 10 days
Drug: Heparin
Nebulized Heparin

Placebo Comparator: Placebo
0.9% Sodium Chloride Dose: 5 mL Frequency: every 4 hours Duration: 10 days
Drug: 0.9% Sodium-chloride
Nebulized 0.9% Sodium Chloride
Other Name: Placebo




Primary Outcome Measures :
  1. Mean daily PaO2 to FiO2 ratio [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: 30 days ]
  2. ICU length of stay [ Time Frame: 30 days ]
  3. Mortality Rate [ Time Frame: 30 days ]
  4. Incidence of adverse drug events [ Time Frame: 10 days ]


Information from the National Library of Medicine

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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:

  • Age ≥18 years
  • Admitted to the intensive care unit
  • Positive COVID-19 PCR
  • Mechanical Ventilation for ≤ 48 hours
  • PaO2/FiO2 ≤300

Exclusion Criteria:

  • Heparin allergy
  • Active bleeding
  • Death or withdraw of care anticipated by intensivist within 24 hours
  • Platelets< 50,000 cells/µL
  • Clinically significant coagulopathy, as decided by the intensivist
  • O2 dependent at baseline

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): NCT04397510


Locations
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United States, Maryland
Frederick Health Hospital
Frederick, Maryland, United States, 21701
Sponsors and Collaborators
Frederick Health
Publications:
Darden DB, Hawkins RB, Larson SD, Iovine NM, Prough DS, Efron PA. The Clinical Presentation and Immunology of Viral Pneumonia and Implications for Management of Coronavirus Disease 2019. Crit Care Explor. 2020;2(4):e0109. doi:10.1097/CCE.0000000000000109

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Responsible Party: Thomas Smoot, PharmD, Critical Care Pharmacy Specialist, Frederick Health
ClinicalTrials.gov Identifier: NCT04397510    
Other Study ID Numbers: FHHep518
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No
Keywords provided by Thomas Smoot, PharmD, Frederick Health:
heparin
COVID-19
ARDS
Acute Lung Injury
Additional relevant MeSH terms:
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Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action