South African trial of Nasodine in COVID-19 receives local approval to proceed
The Company’s planned clinical trial of Nasodine Nasal Spray (povidone-iodine 0.5%) in COVID-19 patients in South Africa, has received approval to proceed from the South African Health Products Regulatory Authority (SAHPRA).
The trial is titled: “Reduction of nasal shedding of SARS-CoV-2 in COVID-19 positive patients by the use of Nasodine® (povidone-iodine 0.5%) Nasal Spray.”
It is intended to demonstrate that frequent, repeated application of Nasodine Nasal Spray (“Nasodine”) in COVID-19 subjects who are RAT-positive, leads to reduction or elimination of nasal shedding of the SarsCoV-2 virus.
The SAHPRA approval specifically allows Firebrick Pharma to import Nasodine into South Africa for the trial and to administer the product to patients during the trial, according to the trial protocol submitted to SAHPRA.
Prior to commencing the trial, Firebrick will also need approval from the local clinical Ethics Committee, which has been applied for but has yet to be received.