Clinical-stage drug development company Dimerix (ASX:DXB) has provided an update on the CLARITY 2.0 study in COVID-19 patients in India.
According to figures from Johns Hopkins University, India recorded more than 750,000 new cases over the last weekend, bringing the cumulative total close to 23 million cases and 250,000 deaths across the country.
The World Health Organization (WHO) has also announced that the coronavirus variant first identified in India last year was being classified as a “variant of global concern…with some preliminary studies suggesting increased transmissibility.”
Dimerix said that following direct communications with Drug Controller General of India (DCGI - Indian regulatory authority), CLARITY 2.0 project management have been advised that as a result of the devastating wave affecting India, some DCGI and hospital staff are reported to have contracted COVID-19.
"Due to the significant number of COVID infections, some DCGI review meetings have been postponed and the final permit required for recruitment initiation of the CLARITY 2.0 study anticipated in April has been delayed," said the company, adding, "Pending DCGI meetings being resumed, all remaining site start-up activities will be completed and sites are expected to start recruiting participants shortly. Advice will be provided when final approvals are received, and when dosing is to commence."
“It is in these times that we can see more acutely how important it is to carry out research in areas that could most benefit from the findings. Despite the many challenges, our investigators, hospital research staff, and central coordinators are courageously continuing to progress COVID-19 research in the midst of a highly pressured situation.” said Erika Dempsey, CLARITY 2.0 clinical trial program manager.
Dimerix said it is not aware of any other material impediment to securing regulatory approval allowing commencement of the CLARITY 2.0 trial.
“Continuing to complete high-quality research is vital in the fight against COVID-19, but the exponential spread of the virus in India is placing significant strain on the local teams’ ability to carry out such research, with a profound impact on collaborating researchers, local hospitals and medical staff. While the global community is rightly focussing on vaccine distribution and provision, there is an ongoing need for research into improving treatments for patients hospitalised with COVID-19, or at risk of heightened disease severity. We are going to need multiple strategies to contain this virus,” said Arlen Wilcox, CLARITY 2.0 clinical trial program manager.