In the current corona pandemic, the protection of medical personnel who have contact with Covid-19 infected patients is important, also to ensure stability of the health care services. The personal protective equipment of hospital staff includes particle filtering respiratory masks. From early 2021, a clinical study will be conducted to investigate the protective effect of a new type of respirator with a filter element containing chitosan nanoparticles in Brazil. More about this study and other current clinical studies with chitosan in this article.
Planned clinical study testing the effectiveness of a novel respirator with chitosan nanoparticles against SARS-CoV-2 infection:
The use of nanomaterials in respiratory masks could reduce the permeability of particles and increase the filtering performance against bacteria and viruses. The positively charged biopolymer chitosan has virucidal activity against several virus types, including coronavirus serotypes. The efficacy of a novel respirator with a filter element containing chitosan nanoparticles (called VESTA) will be investigated in comparison to a conventional N95 respirator. The respirators will be tested on medical personnel working in a hospital environment.
The study will be conducted in two phases:
1) a randomized clinical pilot study with reduced sample (n=50)
2) controlled randomized clinical trial. This study will be conducted with healthcare professionals in contact with environments/patients infected with SARS-CoV-2 or working in hospital sectors with higher susceptibility to infection (emergency and intensive care units). The study participants will be monitored for 21 days and the respiratory masks will be morphologically characterized (virus amount and inactivation) after the end of the first hospital shift.
Primary outcome measures:
- Incidence of laboratory-confirmed COVID-19 cases [time frame: 21 days].
(number of infected professionals, confirmed by RT-PCR)
- Ability of the filter element to inactivate SARS-Cov-2 [time frame: 24 hours].
Find more information here: ClinicalTrials.gov Identifier: NCT04490200
Other current clinical studies with applications using chitosan and chitosan derivatives are listed with title, disease, type of planned medical intervention/device, status and study location below (clinicaltrials.gov, accessed December 15, 2020).
|Status||Title||Disease||Type of planned medical intervention/device||Study location|
|Recruiting||Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore||Pressure Ulcer||Other: sericin and chitosan cream||Thailand|
|Recruiting||Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant||Periapical Abscess||Drug: root canal treatment and intracanal medicament||India|
|Not yet recruiting||Effectiveness of a Novel Respirator With Chitosan Nanoparticles||
Worker-Patient Transmission, Healthcare
Device: VESTA respirator
Device: Conventional N95 respirator
|Not yet recruiting||Evaluation of Antimicrobial Efficacy and Adaptability of Bioceramic Sealer Containing Nanoparticles||Endodontic Disease||Drug: bioceramic sealer||-|
|Recruiting||Combination of InnoSEAL Plus TR Band Compared to TR Band Alone||
Radial Artery Occlusion
Device: TRB alone
|Recruiting||Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors||Advanced Solid Tumors||
Device: Thermal Ablation
||RAVE: Radial Artery Vascular Complication and Resource Utilization in Subjects Undergoing an Angiogram/PCI||
Percutaneous Coronary Intervention
|Device: RadAR EasyCLik plus ®-STF hemostatic pad
Device: TR BAND® Compression device plus ®-STF hemostatic pad
|Not yet recruiting||Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial||Deep Caries||
Drug: Nano Silver Fluoride
Drug: Calcium hydroxide
|Not yet recruiting||Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound||Disorder of Skin Donor Site||
Device: high absorption pad for blood and pus
Device: commercial wound dressing
|Not yet recruiting||Superficial Partial-Thickness Burn Study||Superficial Partial Thickness Burn||
Device: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Drug: Silver Sulfadiazine
|Recruiting||Dentures Biofilm and Artificial Biofilm Substitute||Biofilm||Other: 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it||Germany|
Would you also like to conduct (clinical) trials with chitosan or develop new therapeutics? Contact us, we will be happy to help you select suitable chitosans for your application.