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 : February 23, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid-19 ARDS, Human Acute Lung Injury | Drug: Heparin Drug: 0.9% Sodium-chloride | Phase 4 |

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 |
Actual Study Start Date : | June 1, 2020 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Nebulized Heparin
Heparin 5,000 units/mL Dose: 25,000 units Frequency: every 6 hours Duration: 10 days
|
Drug: Heparin
Nebulized Heparin |
Placebo Comparator: Placebo
0.9% Sodium Chloride Dose: 5 mL Frequency: every 6 hours Duration: 10 days
|
Drug: 0.9% Sodium-chloride
Nebulized 0.9% Sodium Chloride
Other Name: Placebo |
- Mean daily PaO2 to FiO2 ratio [ Time Frame: 10 days ]
- Duration of mechanical ventilation [ Time Frame: 30 days ]
- ICU length of stay [ Time Frame: 30 days ]
- Mortality Rate [ Time Frame: 30 days ]
- Incidence of adverse drug events [ Time Frame: 10 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Maryland | |
Frederick Health Hospital | |
Frederick, Maryland, United States, 21701 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | February 23, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
heparin COVID-19 ARDS Acute Lung Injury |
COVID-19 Lung Injury Acute Lung Injury Respiratory Distress Syndrome Wounds and Injuries Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Thoracic Injuries Respiration Disorders Heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |