Covid19Phase 2NCT04842292
Nebulized Heparin for COVID19-associated Acute Respiratory Failure
A Phase 2 study testing Heparin in people with Covid19, run by Brittany Bissell at 1 site in United States.
Trial summary
The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Heparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 4 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours
Who cannot join
- Allergy to heparin
- Any history of heparin-induced thrombocytopenia
- High risk of bleeding (platelet count < 50,000/µL or international normalized ratio > 1.5)
- Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)
- Active bleeding
- Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring repeated suctioning, and temporally associated with acute deterioration in respiratory status)
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- Neurosurgical procedures during this hospital admission or such procedures are planned
- Epidural catheter in place
- Any history of intracranial, spinal or epidural hemorrhage
- Tracheostomy in place
- Cervical spinal cord injury associated with reduced long-term ability to breathe independently
- Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to breathe independently
- Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy
- Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure
- Death is deemed imminent or inevitable or there is an underlying disease with a life expectancy of fewer than 90 days
- Pregnant or might be pregnant.
- Objection from the treating clinician
- Consent refused by the patient or substitute decision maker.
- History of thrombosis (VTE or cardiovascular event)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure
The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.
- Conditions
- Covid19
- Being tested
- Heparin, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Nebulized heparin 25,000 units every 6 hours
PlaceboDrug
Sodium chloride 0.9% every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Nebulized heparin | Experimental | Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours Receives: Drug: Heparin |
| Nebulized placebo | Placebo comparator | Sodium chloride 0.9% 5 mL inhalation every 6 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean PaO2/FiO2 Ratio
Measured: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
Secondary outcomes (2)
Clinically Significant Bleeding
Measured: Up to discharge or 3 months following enrollment, whichever occurs first
Incidence of Venous Thromboembolism
Measured: Up to discharge or 3 months following enrollment, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start20 May 2021
- Primary completion4 Sep 2021
- Study completion4 Sep 2021
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brittany Bissell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brittany Bissell, University of Kentucky
- Investigators
- Brittany D Bissell, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842292
- Sponsor's protocol ID
- 65139
- Status last verified
- Oct 2022
- First submitted
- 8 Apr 2021
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT04842292
- Acronym / sponsor ID
- 65139
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Brittany BissellUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 4 Sep 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Posted 18 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized heparin | Experimental | Drug: HeparinNebulized heparin 25,000 units in 3 mL inhalation every 6 hours |
| Nebulized placebo | Placebo comparator | Drug: PlaceboSodium chloride 0.9% 5 mL inhalation every 6 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours
Key exclusion criteria (19 listed)
- Allergy to heparin
- Any history of heparin-induced thrombocytopenia
- High risk of bleeding (platelet count < 50,000/µL or international normalized ratio > 1.5)
- Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)
- Active bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeparinNebulized heparin 25,000 units every 6 hours | Drug | Nebulized heparin |
| PlaceboSodium chloride 0.9% every 6 hours | Drug | Nebulized placebo |
Primary outcome
Mean PaO2/FiO2 Ratio
Time frame: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
2 secondary outcomes
Clinically Significant Bleeding
Time frame: Up to discharge or 3 months following enrollment, whichever occurs first
Incidence of Venous Thromboembolism
Time frame: Up to discharge or 3 months following enrollment, whichever occurs first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany D Bissell principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Heparin in people with Covid19, run by Brittany Bissell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean PaO2/FiO2 Ratio (time frame: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.