COVID-19 Acute Respiratory Distress SyndromePhase 2/3NCT04990830
Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia
A Phase 2/3 study testing Inhaled Low molecular weight heparin and Standard Treatment in people with COVID-19 Acute Respiratory Distress Syndrome and Hypoxemia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This is an investigator initiated, single-center, open-label, Phase IIb clinical trial with 40 patients (for a total of 80 patients) to assess efficacy of Low molecular weight heparin using soft mist inhaler in the treatment of critically ill patients with COVID-19 (coronavirus disease of 2019) induced ARDS (acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Hypoxemia
- What is being tested?
- Inhaled Low molecular weight heparin and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2021to 21 May 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive reserve transcriptase polymerase chain reaction (RT-PCR) test of nasopharyngeal swab for COVID- 19, and pneumonia confirmed by a Computed Tomography (CT).
- Negative reserve transcriptase polymerase chain reaction (RT-PCR) test of nasopharyngeal swab for COVID- 19, but radiological and biochemical examinations unambiguously suggest COVID-19, when other possible diagnoses were excluded.
Who cannot join
- Pregnancy
- History of heparin and associated drug allergies.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Medical Faculty
Istanbul, Fatih, 34093
About this study
Official title: Early Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia: A Phase IIb Trial
This is an investigator initiated, single-center, open-label, Phase IIb clinical trial with 40 patients (for a total of 80 patients) to assess efficacy of Low molecular weight heparin using soft mist inhaler in the treatment of critically ill patients with COVID-19 (coronavirus disease of 2019) induced ARDS (acute respiratory distress syndrome). The patients will be assigned in a 1:1 ratio to receive standard treatment protocol plus inhaled Low molecular weight heparin. The primary objective is to determine the hypoxemia improvement on a 5-point clinical scale for COVID-19 induced ARDS patients.
Read the detailed description
Lungs are the major target organ of COVID-19, caused by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). Multiple drug options have been evaluated for efficacy against worsening symptoms of COVID-19 patients. Low molecular weight heparin, known for its antiviral and anti-inflammatory effect, was determined to be applicable for ARDS-induced Hypoxemia.
In cases of viral diseases that primarily targets the lungs, oral drugs and parenteral applications have shown to be insufficient due to low drug accumulation in the target organ site. An increase in drug dosage in order to achieve the necessary drug concentration leaves the patient with intolerable side effects. An inhalation delivery route of the drug would not only directly target the lungs but would also require less dosage. This is expected to increase patient tolerability and the efficacy of the treatment.
Soft mist inhalers are advantageous above the other inhalation devices, for it reaches a higher retention rate in the lungs. Furthermore, the device to be used in this clinical study provides an "enclosed system" which decreases the risk of environmental contamination, thus is meant to protect healthcare professionals or to minimize associated contamination risks.
This Phase-IIb clinical trial is to include 40 critically ill COVID-19 induced ARDS patients, that will receive Low molecular Weight Heparin via a soft mist inhaler at a dose of 4000 IU per administration, twice a day for 10 days in addition to the standard treatment determined by the Turkish Ministry of Health. A total of 80 patients will be enrolled, in which the drug receiving group will be assigned. The primary outcome of the clinical study is the improvement of ARDS induced hypoxemia on a 5-scale determination method at the end of the 10th day. The study inquires to perceive the early effects of inhaled Low molecular weight heparin on critically ill COVID-19 patients.
- Being tested
- Inhaled Low molecular weight heparin, Standard Treatment
- Keywords
- Heparin, Low Molecular Weight Heparin, Inhalation, Antiviral, Soft Mist Inhaler
- Medical subject headings
- Hypoxia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Low molecular weight heparinDrug
Also called Enoxaparin Sodium
Application with Soft Mist Inhaler
Control Group
| Study group | Role | What they receive |
|---|---|---|
| Inhalation Treatment | Experimental | Treatment: Inhaled Low molecular weight heparin + Standard COVID-19 treatment,
Inhaled Low molecular weight heparin (4000 IU given twice a day for 10 days) Receives: Drug: Inhaled Low molecular weight heparin |
| Control Group | Other | Treatment: Standard COVID-19 treatment Receives: Drug: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical status on a 5-point clinical scale for hypoxemia
- Level 1: if the patient can breathe comfortably in the room air.
- Level 2: if the peripheral oxygen saturation improves with an oxygen therapy up to 6 L/min via nasal cannula.
- Level 3: If it can be improved with a 500 mL reservoir oxygen mask with 15 L/min oxygen treatment.
- Level 4: If it can be improved with high flow oxygen therapy.
- Level 5: If the intubation is the only choice.
Measured: Days 1-10
Secondary outcomes (4)
Improvement rate of the breathing status
Change in number of patients that were able to breath in room air will be compared on Day 1 and Day 10 (Comparison between the Treatment Group and Control Group)
Measured: Day 1 and Day 10
Change in peripheral oxygen saturation (Sp02)
A change in SpO2 levels in the duration of the study (SpO2 < % 95)
Measured: Days 1-10
Length of stay
Number of patients administered to intensive care unit (ICU)
Measured: Days 1-10
Overall survival
During or post-study follow up period
Measured: Days 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start3 Feb 2021
- Primary completion21 Apr 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Treatment Group - Control Group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Yildiz-Pekoz, Istanbul University
- Investigators
- Ayca Yildiz-Pekoz, PhD, Study chair, Istanbul University Faculty of PharmacyMustafa Erelel, MD, Study director, Istanbul University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990830
- Sponsor's protocol ID
- E-66175679-514.03.01-328141
- Other IDs
- 46325
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be decided on a later date depending on completion of further study Phases
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia: A Phase IIb Trial
- ClinicalTrials.gov ID
- NCT04990830
- Acronym / sponsor ID
- E-66175679-514.03.01-328141
- Keywords
- Heparin, Low Molecular Weight Heparin, Inhalation, Antiviral, Soft Mist Inhaler
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator initiated, single-center, open-label, Phase IIb clinical trial with 40 patients (for a total of 80 patients) to assess efficacy of Low molecular weight heparin using soft mist inhaler in the treatment of critically ill patients with COVID-19 (coronavirus disease of 2019) induced ARDS (acute respiratory distress syndrome). The patients will be assigned in a 1:1 ratio to receive standard treatment protocol plus inhaled Low molecular weight heparin. The primary objective is to determine the hypoxemia improvement on a 5-point clinical scale for COVID-19 induced ARDS patients.
Detailed description
Lungs are the major target organ of COVID-19, caused by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). Multiple drug options have been evaluated for efficacy against worsening symptoms of COVID-19 patients. Low molecular weight heparin, known for its antiviral and anti-inflammatory effect, was determined to be applicable for ARDS-induced Hypoxemia.
In cases of viral diseases that primarily targets the lungs, oral drugs and parenteral applications have shown to be insufficient due to low drug accumulation in the target organ site. An increase in drug dosage in order to achieve the necessary drug concentration leaves the patient with intolerable side effects. An inhalation delivery route of the drug would not only directly target the lungs but would also require less dosage. This is expected to increase patient tolerability and the efficacy of the treatment.
Soft mist inhalers are advantageous above the other inhalation devices, for it reaches a higher retention rate in the lungs. Furthermore, the device to be used in this clinical study provides an "enclosed system" which decreases the risk of environmental contamination, thus is meant to protect healthcare professionals or to minimize associated contamination risks.
This Phase-IIb clinical trial is to include 40 critically ill COVID-19 induced ARDS patients, that will receive Low molecular Weight Heparin via a soft mist inhaler at a dose of 4000 IU per administration, twice a day for 10 days in addition to the standard treatment determined by the Turkish Ministry of Health. A total of 80 patients will be enrolled, in which the drug receiving group will be assigned. The primary outcome of the clinical study is the improvement of ARDS induced hypoxemia on a 5-scale determination method at the end of the 10th day. The study inquires to perceive the early effects of inhaled Low molecular weight heparin on critically ill COVID-19 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment Group - Control Group
| Arm | Type | Receives |
|---|---|---|
| Inhalation Treatment | Experimental | Drug: Inhaled Low molecular weight heparinTreatment: Inhaled Low molecular weight heparin + Standard COVID-19 treatment, Inhaled Low molecular weight heparin (4000 IU given twice a day for 10 days) |
| Control Group | Other | Drug: Standard TreatmentTreatment: Standard COVID-19 treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Positive reserve transcriptase polymerase chain reaction (RT-PCR) test of nasopharyngeal swab for COVID- 19, and pneumonia confirmed by a Computed Tomography (CT).
- Negative reserve transcriptase polymerase chain reaction (RT-PCR) test of nasopharyngeal swab for COVID- 19, but radiological and biochemical examinations unambiguously suggest COVID-19, when other possible diagnoses were excluded.
Key exclusion criteria (2 listed)
- Pregnancy
- History of heparin and associated drug allergies.
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 |
|---|---|---|
| Inhaled Low molecular weight heparinAlso: Enoxaparin SodiumApplication with Soft Mist Inhaler | Drug | Inhalation Treatment |
| Standard TreatmentControl Group | Drug | Control Group |
Primary outcome
Change in clinical status on a 5-point clinical scale for hypoxemia
Time frame: Days 1-10
* Level 1: if the patient can breathe comfortably in the room air. * Level 2: if the peripheral oxygen saturation improves with an oxygen therapy up to 6 L/min via nasal cannula. * Level 3: If it can be improved with a 500 mL reservoir oxygen mask with 15 L/min oxygen treatment. * Level 4: If it can be improved with high flow oxygen therapy. * Level 5: If the intubation is the only choice.
4 secondary outcomes
Improvement rate of the breathing status
Time frame: Day 1 and Day 10
Change in peripheral oxygen saturation (Sp02)
Time frame: Days 1-10
Length of stay
Time frame: Days 1-10
Overall survival
Time frame: Days 1-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Republic of Turkey Ministry of Health website on COVID-19Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data sharing will be decided on a later date depending on completion of further study Phases
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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.
Ayca Yildiz-Pekoz, PhD study chair
Istanbul University Faculty of Pharmacy
Mustafa Erelel, MD study director
Istanbul University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Inhaled Low molecular weight heparin and Standard Treatment in people with COVID-19 Acute Respiratory Distress Syndrome and Hypoxemia, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Aug 2021. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in clinical status on a 5-point clinical scale for hypoxemia (time frame: Days 1-10). 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 5 Aug 2021.