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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial will test if nebulized heparin can help treat severe lung injury caused by COVID-19.
Eligible Conditions
- Coronavirus
- Acute Respiratory Distress Syndrome
- Acute Lung Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean daily PaO2 to FiO2 ratio
Secondary outcome measures
Duration of mechanical ventilation
ICU length of stay
Incidence of adverse drug events
+1 moreSide effects data
From 2008 Phase 4 trial • 541 Patients • NCT002773949%
Urinary tract infection
8%
Haematoma
6%
Constipation
4%
Pain in extremity
4%
Diarrhoea
2%
Deep vein thrombosis
2%
Cardiac failure
1%
International normalised ratio increased
1%
Melaena
1%
Subcutaneous haematoma
1%
Coagulation time prolonged
1%
Left ventricular failure
1%
Multi-organ failure
1%
Fall
1%
Sudden death
1%
Death
1%
General physical health deterioration
1%
Lung neoplasm malignant
1%
Metastatic neoplasm
1%
Respiratory failure
1%
Pulmonary embolism
1%
Depression
1%
Anaemia
1%
Rectal haemorrhage
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Innohep®
Heparin
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nebulized HeparinExperimental Treatment1 Intervention
Heparin 5,000 units/mL Dose: 25,000 units Frequency: every 6 hours Duration: 10 days
Group II: PlaceboPlacebo Group1 Intervention
0.9% Sodium Chloride Dose: 5 mL Frequency: every 6 hours Duration: 10 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heparin
FDA approved
Find a Location
Who is running the clinical trial?
Frederick HealthLead Sponsor
2 Previous Clinical Trials
535 Total Patients Enrolled
Frequently Asked Questions
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