COVIDVADERNCT04375774
Verification of Alternative Do-it-yourself Equipment Respirators for the COVID-19 Personal Protective Equipment (PPE)
A study testing FFP2, Facial mask and MFS in people with COVID, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The COVID-19 pandemic health crisis forces health institutions to lower their standards of protection as supplies of personal protective equipment decrease despite the safety of front-line workers worldwide . This shortage specifically affects high-quality protective masks, such as those called FFP2. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID
- What is being tested?
- FFP2, Facial mask and MFS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- May 2020to May 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult volunteers working in a first line healthcare service with basic knowledge of donning PPE including respirators
- 5 females and 5 males
Who cannot join
- smoking or unhealthy participants with respiratory affections to avoid breathing difficulties during testing
- any known allergy towards medical silicone or any other material of each component and ingredients used for disinfection of the test area and material between participants
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Guillaume Lemaire, MD, +322764-1870, guillaume.lemaire@uclouvain.be
Marco Pettinger, MD, 00352 661 90 20 39, marco@msg.lu
About this study
Official title: Verification of Alternative Do-it-yourself Equipment Respirators
The COVID-19 pandemic health crisis forces health institutions to lower their standards of protection as supplies of personal protective equipment decrease despite the safety of front-line workers worldwide . This shortage specifically affects high-quality protective masks, such as those called FFP2. As alternatives, we offer a reusable mask based on a ventilation mask combined with a breathing filter for anesthesia breathing circuits. The purpose of the study is to assess the sealing potential of this mask in the field and possibly prove a non-inferior sealing compared to standard masks type FFP2.
Read the detailed description
The ongoing 2020 COVID-19 pandemic challenges healthcare providers (HCP) worldwide with a rapid consumption and shortage of personal protection equipment (PPE), especially high-level filtration respirator masks. Respirators used by HCPs are mainly single use face filtering pieces with at least level P2 protection for single shift use following European EN 149 standards defining protection level against hazardous particles.
In response to the risk of shortage we propose a novel reusable do-it-yourself (DIY) respirator assembled with already widely available components in hospital stocks: a standard breathing filter plugged in an anaesthesia facial mask held in place with a hook ring strapped to a silicone head harness. As reports of a modified full-face snorkelling (MFS) mask used for non-invasive ventilation in infected patients emerged in Italy, we reckon that it could also be used as PPE with a modified valve and breathing filter.
- Conditions
- COVID
- Being tested
- FFP2, Facial mask, MFS
- Keywords
- COVID, protection equipment, 3d printable valve, fit test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFP2Device
Face Fit test of the FFP2 with the PortaCount® PRO+ 8038 from TSI
Facial maskDevice
Face Fit test of a conventional respirator facial mask with the PortaCount® PRO+ 8038 from TSI
MFSDevice
Face fit test of a MFS with the PortaCount® PRO+ 8038 from TSI
| Study group | Role | What they receive |
|---|---|---|
| FFP2 | Other | Not described Receives: Device: FFP2 |
| Facial mask | Other | Not described Receives: Device: Facial mask |
| Modified full-face snorkeling | Other | Not described Receives: Device: MFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of airtightness (Fit test)
Non inferiority claim over FFP2
Measured: Up to 1 week
Secondary outcomes (4)
User Comfort
User face comfort for each type of mask assessed by a assessed by a scoring-cale from 1 to 5
Measured: Up to 1 week
Breathing easiness
User respiratory easiness for each type of mask assessed by a scoring-cale from 1 to 5
Measured: Up to 1 week
Field of view quality
User field of view quality for each type of mask assessed by a scoring-cale from 1 to 5
Measured: Up to 1 week
Ease of use
How the device is user friendly, assessed by a scoring-cale from 1 to 5
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Enrolment will be a onetime selection of 10 healthy volunteers
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Lemaire, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375774
- Sponsor's protocol ID
- 2020/15AVR/226
- Acronym
- VADER
- Status last verified
- May 2020
- First submitted
- 17 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be presented in the future manuscript
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Alternative Do-it-yourself Equipment Respirators
- ClinicalTrials.gov ID
- NCT04375774
- Acronym / sponsor ID
- VADER / 2020/15AVR/226
- Conditions
- COVID
- Keywords
- COVID, protection equipment, 3d printable valve, fit test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 5 May 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 COVID-19 pandemic health crisis forces health institutions to lower their standards of protection as supplies of personal protective equipment decrease despite the safety of front-line workers worldwide . This shortage specifically affects high-quality protective masks, such as those called FFP2. As alternatives, we offer a reusable mask based on a ventilation mask combined with a breathing filter for anesthesia breathing circuits. The purpose of the study is to assess the sealing potential of this mask in the field and possibly prove a non-inferior sealing compared to standard masks type FFP2.
Detailed description
The ongoing 2020 COVID-19 pandemic challenges healthcare providers (HCP) worldwide with a rapid consumption and shortage of personal protection equipment (PPE), especially high-level filtration respirator masks. Respirators used by HCPs are mainly single use face filtering pieces with at least level P2 protection for single shift use following European EN 149 standards defining protection level against hazardous particles.
In response to the risk of shortage we propose a novel reusable do-it-yourself (DIY) respirator assembled with already widely available components in hospital stocks: a standard breathing filter plugged in an anaesthesia facial mask held in place with a hook ring strapped to a silicone head harness. As reports of a modified full-face snorkelling (MFS) mask used for non-invasive ventilation in infected patients emerged in Italy, we reckon that it could also be used as PPE with a modified valve and breathing filter.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Enrolment will be a onetime selection of 10 healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| FFP2 | Other | Device: FFP2 |
| Facial mask | Other | Device: Facial mask |
| Modified full-face snorkeling | Other | Device: MFS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- adult volunteers working in a first line healthcare service with basic knowledge of donning PPE including respirators
- 5 females and 5 males
Key exclusion criteria (2 listed)
- smoking or unhealthy participants with respiratory affections to avoid breathing difficulties during testing
- any known allergy towards medical silicone or any other material of each component and ingredients used for disinfection of the test area and material between participants
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 |
|---|---|---|
| FFP2Face Fit test of the FFP2 with the PortaCount® PRO+ 8038 from TSI | Device | FFP2 |
| Facial maskFace Fit test of a conventional respirator facial mask with the PortaCount® PRO+ 8038 from TSI | Device | Facial mask |
| MFSFace fit test of a MFS with the PortaCount® PRO+ 8038 from TSI | Device | Modified full-face snorkeling |
Primary outcome
Evaluation of airtightness (Fit test)
Time frame: Up to 1 week
Non inferiority claim over FFP2
4 secondary outcomes
User Comfort
Time frame: Up to 1 week
Breathing easiness
Time frame: Up to 1 week
Field of view quality
Time frame: Up to 1 week
Ease of use
Time frame: Up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: No. All data will be presented in the future manuscript
Related trials for COVID
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
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
Guillaume Lemaire, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFP2, Facial mask and MFS in people with COVID, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 5 May 2020. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Lemaire, MD (+3227641870, guillaume.lemaire@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of airtightness (Fit test) (time frame: Up to 1 week). 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 May 2020.