SPL7013 Nasal Spray Trial for Patients with COVID-19
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study to evaluate the performance and safety of SPL7013 Nasal Spray in non-hospitalised patients with COVID-19
IRAS ID
320408
Contact name
Stephen Winchetser
Contact email
Sponsor organisation
Starpharma Pty Ltd
ISRCTN Number
ISRCTN70449927
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
SPL7013 has been shown to have potent in vitro and in vivo antiviral and virucidal effects against SARS-CoV-2 and other respiratory viruses, which has warranted the development of a SPL7013 Nasal Spray to block and reduce viral load for pre- and post-exposure treatment of colds and respiratory infections, including COVID-19.
SPL7013 Nasal Spray has been shown to be safe and tolerable when repeatedly applied to the nasal mucosa of healthy volunteers. Furthermore, there have been no reportable incidents for the device since its registration in Europe (February 2021) or in the UK (March 2022).
The objective of the present clinical investigation is to evaluate the performance of SPL7013 Nasal Spray in reducing SARS-CoV-2 viral load in non-hospitalised COVID-19 patients, and in preventing progression of disease.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0252
Date of REC Opinion
24 Nov 2022
REC opinion
Further Information Favourable Opinion