Covid19OxyJet-CPAPNCT04681859
Evaluation of a Low-cost CPAP Device on Hospitalized COVID-19 Patients
A study testing High Flow Nasal Oxygen (HFNO) treatment and Continuous Positive Airway Pressure (CPAP) therapy using OxyJet in people with Covid19 and Hypoxemia, run by Bangladesh University of Engineering and Technology at 1 site in Bangladesh.
Trial summary
The aim of this study is to evaluate the preliminary safety and performance of a low-cost locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for hypoxemic COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- High Flow Nasal Oxygen (HFNO) treatment and Continuous Positive Airway Pressure (CPAP) therapy using OxyJet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBangladesh
- Study dates
- 17 Apr 2021to 9 Aug 2021
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Confirmed or suspected COVID-19 patient (by RT-PCR) having severe pneumonia and hypoxemia (SpO2 ≤90%) who did not respond to standard oxygen therapy (non-rebreather mask on 15L/min at 100% FiO2).
Who cannot join
- Severely hypoxemic patients (SpO2≤85%)
- Patients with low respiratory drive or requiring cardiopulmonary resuscitation
- Patients with contraindications for CPAP
- Pregnant status
- Age > 65 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Evaluation of a Low-cost CPAP Device for Hypoxemic COVID-19 Patients: A Pilot Study
The aim of this study is to evaluate the preliminary safety and performance of a low-cost locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for hypoxemic COVID-19 patients. The device administers Continuous Positive Airway Pressure (CPAP) therapy using the jet-mixing or Venturi effect to increase the volume flow rate of oxygenated air from a pressurized cylinder by entraining the atmospheric air. To provide CPAP therapy, this high flow of oxygenated air is delivered to the patient via a low-cost non-vented mask with a tight seal with a High-Efficiency Particulate Air (HEPA) filter connected to the exhalation limb. The tight seal and HEPA filter ensures a minimal risk of aerosol generation and thus the device can be used without a negative pressure room. The system consists of the developed Venturi-based flow-generator, a standard 22mm breathing tube, a standard Y-connector, a non-vented CPAP mask (e.g., snorkel mask, helmet), a HEPA filter, and a Positive End Expiratory Pressure (PEEP) valve. The bench-top testing of the device is done in the laboratories of BUET and was verified that the device performs within the CPAP guidelines provided by the Medicines and Healthcare products Regulatory Agency (MHRA), UK. This study aims to assess the safety of and efficacy of the device in three different steps: (1) design validation, (2) clinical feasibility and (3) pilot clinical trial for safety and efficacy evaluation. Only if the device successfully passes the parts 1 and 2, the investigators will proceed to the final clinical trial in step 3. In this final step, the investigators aim to conduct a randomized controlled trial (RCT) evaluating for non-inferiority of the CPAP intervention compared to standard HFNO treatment. The number of ventilator-free days will be used as the primary outcome for efficacy, while patient recovery, death, or need of intubation and other adverse events will be used as secondary outcomes.
- Being tested
- High Flow Nasal Oxygen (HFNO) treatment, Continuous Positive Airway Pressure (CPAP) therapy using OxyJet
- Medical subject headings
- COVID-19, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Oxygen (HFNO) treatmentDevice
Administration of High Flow Nasal Oxygen (HFNO) to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). Adjust flow-rate and FiO2 as per standard HFNO treatment protocol.
Continuous Positive Airway Pressure (CPAP) therapy using OxyJetDevice
Administer CPAP to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). CPAP initiated with FiO2 at 40% and a 10cm PEEP. Titrate PEEP to 15 cm if required. Deliver additional oxygen via secondary port if a higher FiO2 is required.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Oxygen (HFNO) treatment | Active comparator | Not described Receives: Device: High Flow Nasal Oxygen (HFNO) treatment |
| Continuous positive airway pressure (CPAP) therapy using OxyJet | Experimental | Not described Receives: Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator-free days
The total number of days the patient was able to avoid being placed under a mechanical ventilator.
Measured: 10 days
Secondary outcomes (3)
Recovery of the patient
The event that the patient has recovered and released from the hospital within 30 days.
Measured: 30 days
Death or need of intubation
The event that the patient dies or requires to be placed under a mechanical ventilator.
Measured: 10 days
Oxygen toxicity or other adverse events
Oxygen toxicity or other adverse event rating according to the CTCAE scale (1-5)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start17 Apr 2021
- Primary completion9 Jul 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh University of Engineering and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Dhaka Medical College
- Responsible party
- Sponsor
- Investigators
- Dr. Taufiq Hasan, PhD, Principal investigator, Bangladesh University of Engineering and TechnologyDr. Robed Amin, MBBS, FCPS, Principal investigator, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681859
- Sponsor's protocol ID
- BME-BUET-003
- Acronym
- OxyJet-CPAP
- Status last verified
- Mar 2022
- First submitted
- 22 Dec 2020
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of a Low-cost CPAP Device for Hypoxemic COVID-19 Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT04681859
- Acronym / sponsor ID
- OxyJet-CPAP / BME-BUET-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bangladesh University of Engineering and TechnologyUniversity, hospital or other
- Collaborators
- Dhaka Medical College
- Study start
- 17 Apr 2021 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 23 Dec 2020 (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.
The aim of this study is to evaluate the preliminary safety and performance of a low-cost locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for hypoxemic COVID-19 patients. The device administers Continuous Positive Airway Pressure (CPAP) therapy using the jet-mixing or Venturi effect to increase the volume flow rate of oxygenated air from a pressurized cylinder by entraining the atmospheric air. To provide CPAP therapy, this high flow of oxygenated air is delivered to the patient via a low-cost non-vented mask with a tight seal with a High-Efficiency Particulate Air (HEPA) filter connected to the exhalation limb. The tight seal and HEPA filter ensures a minimal risk of aerosol generation and thus the device can be used without a negative pressure room. The system consists of the developed Venturi-based flow-generator, a standard 22mm breathing tube, a standard Y-connector, a non-vented CPAP mask (e.g., snorkel mask, helmet), a HEPA filter, and a Positive End Expiratory Pressure (PEEP) valve. The bench-top testing of the device is done in the laboratories of BUET and was verified that the device performs within the CPAP guidelines provided by the Medicines and Healthcare products Regulatory Agency (MHRA), UK. This study aims to assess the safety of and efficacy of the device in three different steps: (1) design validation, (2) clinical feasibility and (3) pilot clinical trial for safety and efficacy evaluation. Only if the device successfully passes the parts 1 and 2, the investigators will proceed to the final clinical trial in step 3. In this final step, the investigators aim to conduct a randomized controlled trial (RCT) evaluating for non-inferiority of the CPAP intervention compared to standard HFNO treatment. The number of ventilator-free days will be used as the primary outcome for efficacy, while patient recovery, death, or need of intubation and other adverse events will be used as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Oxygen (HFNO) treatment | Active comparator | Device: High Flow Nasal Oxygen (HFNO) treatment |
| Continuous positive airway pressure (CPAP) therapy using OxyJet | Experimental | Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Confirmed or suspected COVID-19 patient (by RT-PCR) having severe pneumonia and hypoxemia (SpO2 ≤90%) who did not respond to standard oxygen therapy (non-rebreather mask on 15L/min at 100% FiO2).
Key exclusion criteria (5 listed)
- Severely hypoxemic patients (SpO2≤85%)
- Patients with low respiratory drive or requiring cardiopulmonary resuscitation
- Patients with contraindications for CPAP
- Pregnant status
- Age > 65 years
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 |
|---|---|---|
| High Flow Nasal Oxygen (HFNO) treatmentAdministration of High Flow Nasal Oxygen (HFNO) to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). Adjust flow-rate and FiO2 as per standard HFNO treatment protocol. | Device | High Flow Nasal Oxygen (HFNO) treatment |
| Continuous Positive Airway Pressure (CPAP) therapy using OxyJetAdminister CPAP to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). CPAP initiated with FiO2 at 40% and a 10cm PEEP. Titrate PEEP to 15 cm if required. Deliver additional oxygen via secondary port if a higher FiO2 is required. | Device | Continuous positive airway pressure (CPAP) therapy using OxyJet |
Primary outcome
Number of ventilator-free days
Time frame: 10 days
The total number of days the patient was able to avoid being placed under a mechanical ventilator.
3 secondary outcomes
Recovery of the patient
Time frame: 30 days
Death or need of intubation
Time frame: 10 days
Oxygen toxicity or other adverse events
Time frame: 10 days
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 25 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Dr. Taufiq Hasan, PhD principal investigator
Bangladesh University of Engineering and Technology
Dr. Robed Amin, MBBS, FCPS principal investigator
Dhaka Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Oxygen (HFNO) treatment and Continuous Positive Airway Pressure (CPAP) therapy using OxyJet in people with Covid19 and Hypoxemia, run by Bangladesh University of Engineering and Technology at 1 site in Bangladesh.
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 5 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 25 Mar 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 Bangladesh. 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.
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?
Number of ventilator-free days (time frame: 10 days). 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 25 Mar 2022.