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NCT05079308

Clinical Trial on the Efficacy of Different Masks With and Without a Peripheral Sealing Device, Against Covid-19

Completed NA Last updated 26 October 2021
What this trial tests

NA trial testing Peripheral sealing device for surgical mask or filtering face piece in Covid19 in 210 participants. Completed in 31 August 2021.

Timeline
1 March 2021
Primary endpoint
30 June 2021
31 August 2021

Quick facts

Lead sponsorUniversity of the Balearic Islands
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment210
Start date1 March 2021
Primary completion30 June 2021
Estimated completion31 August 2021
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Covid19

Currently open trials in the same condition.

Other University of the Balearic Islands trials

Trials by the same sponsor.

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Data sources for this page

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