Clinical trial
Nebulized Heparin vs. Placebo for the Treatment of COVID-19 Induced Lung Injury
Name
FHHep518
Description
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
Trial arms
Trial start
2020-06-01
Estimated PCD
2021-12-31
Trial end
2021-12-31
Status
Terminated
Phase
Early phase I
Treatment
Heparin
Nebulized Heparin
Arms:
Nebulized Heparin
0.9% Sodium-chloride
Nebulized 0.9% Sodium Chloride
Arms:
Placebo
Other names:
Placebo
Size
13
Primary endpoint
Mean daily PaO2 to FiO2 ratio
10 days
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}
Updated at
2024-04-03
1 organization
2 products
4 indications
Organization
Frederick HealthProduct
HeparinIndication
COVID-19Indication
ARDSIndication
HumanIndication
ALIProduct
Sodium-chloride