There is one clinical trial.

Clinical Trials

1 Effectiveness of a Novel Respirator With Chitosan Nanoparticles to Reduce the Incidence of SARS-CoV-2 Infection in Healthcare Professionals: Randomized Controlled Trial (VESTA Trial)

The use of nanomaterials in facial respirators could decrease the permeability of particles and promote a biocidal effect compared to conventional respirators (N95) and, therefore, enhance the filtering power, aiming to mitigate harmful effects of bacteria and viruses. Chitosan is a natural cationic polymer derived from chitin, with important characteristics such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity. This polymer shows virucidal activity in several types of viruses, including other coronavirus serotypes, given the attractive factor of its cationic charge for negative charges. The effectiveness of a novel individual protection semi facial respirator (called VESTA) will be investigated, compared to a conventional N95 respirator. The respirators will be tested in healthcare professionals working in hospital environments and the effectiveness will be attributed to the lower incidence rate of infection by the SARS-CoV-2. The effectiveness of respirators will also be attributed to the ability to filter these viruses after use by healthcare professionals exposed to potentially contaminated environments. The study will be carried out in two stages: i) Pilot Randomized Clinical Trial with reduced sample and ii) Controlled Randomized Clinical Trial (RCT). This RCT will be conducted with healthcare professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital sectors with greater vulnerability to infection (urgency, emergency and intensive care units). The pilot trial will be conducted initially with a group of fifty participants (n = 25 in each group) for initial investigation of the potential for efficacy with the use of the respirators (VESTA and conventional N95) in two sectors (emergency and ICU) of a Hospital. The RCT will consist of two parallel groups: (1) Experimental Group (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use the standard respirator (N95). Participants will be recruited from participating centers and will be accompanied by eight consecutive shifts (each shift lasting 6 to 12 hours, followed by approximately 36 hours of rest). Participants will be accompanied during 21 days, and will be assessed at baseline (T0), at the end of the 10th day (T1) and at the end of the 21st day (T2). The respirators will be assessed after the end of the 1st hospital shift for morphological characterization (virus quantity and inactivation).

NCT04490200 Covid19 SARS-CoV Infection Worker-Patient Transmission, Healthcare Device: VESTA respirator Device: Conventional N95 respirator

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

No related HPO nodes (Using clinical trials)