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NCT05079308
Clinical Trial on the Efficacy of Different Masks With and Without a Peripheral Sealing Device, Against Covid-19
NA trial testing Peripheral sealing device for surgical mask or filtering face piece in Covid19 in 210 participants. Completed in 31 August 2021.
30 June 2021
Quick facts
| Lead sponsor | University of the Balearic Islands |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 210 |
| Start date | 1 March 2021 |
| Primary completion | 30 June 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Peripheral sealing device for surgical mask or filtering face piece
- IIR Surgical mask with Filtering face piece
Conditions studied
- Covid19 — all drugs for Covid19 →
- Personal Protective Equipment — all drugs for Personal Protective Equipment →
Sponsor
University of the Balearic Islands
Who can join
Adults 18 to 65, any sex, with Covid19 or Personal Protective Equipment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A significant number of professionals subjected to high-risk situations have been infected by Covid-19, due to the lack of adequate respiratory protection equipment or poor marginal sealing adjustments. Then, the objective of this study is to determine if there are statistically significant differences in the level of respiratory protection of type IIR surgical face masks and filtering face masks, used with and without a peripheral sealing device, against the contagion of Covid-19 or other harmful biological agents. The proposed device is a thermoplastic resin ring composed of a reusable and biodegradable polylactic acid designed to be used in a healthcare environment. The individuals of the study will be submitted to qualitative fit tests, that meet current Ocupational Security and Health Administration (OSHA) standard. The mentioned qualitative fit test uses a sodium saccharin solution to evaluate the respiratory protection equipment in professionals in hospitals, emergency centers, and early childhood education centers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05079308
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of the Balearic Islands trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05079308 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of the Balearic Islands
- Last refreshed: 26 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05079308.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing