Geweren_Gerrit schreef op 25 januari 2021 22:03:
Het blijkt dat in India ook het eea gaat gebeuren via Dr Reddys wap.business-standard.com/article/com...Dr Reddy's, Zuventus get nod to conduct Covid-19 trials on repurposed drugs
The subject expert committee (SEC) has given the go-ahead to a clutch of firms, including Dr Reddy’s Laboratories (DRL) and Zuventus Healthcare, to conduct clinical trials on repurposed drugs for Covid-19.
Mumbai’s Zuventus and Hyderabad’s DRL have got the nod to conduct Phase 3 clinical trials of Aviptadil injectable formulation. Aviptadil — a vasoactive intestinal polypetide used to treat erectile dysfunction — has been found to be useful in treating respiratory distress in Covid-19 patients. The US Food and Drug Administration has allowed emergency-use of the drug for treating Covid-19 patients.
NeuroRx and Relief Therapeutics have partnered to develop a drug called RLF-100 that has anti-inflammatory and anti-cytokine activity properties.
The SEC noted that Zuventus had presented revised Phase 3 clinical trial protocol before the committee, and after “detailed deliberation”, it recommended grant of permission of Phase 3 trials with the drug, “subject to condition that criteria for discharge of patients from intensive care unit should be defined clearly in the protocol”.
As for DRL, the SEC has noted that the trial should be termed Phase 3 clinical trial instead of Phase 2/3 trial.
Another drug Colchicine, used to treat gout, is also going to be tested for treating Covid patients. Telangana-based LAXAI Life Sciences has been recommended a grant of permission for Phase 2 trial with some conditions like blood pressure should be measured for inclusion of patients, discharge criteria should be specified, etc. Canadian researchers have said the use of Colchicine can reduce the risk of death or hospitalisation in Covid patients by 21 per cent.
SEC seeks data on SII, Bharat Biotech jabs
Pune’s Serum Institute of India (SII) has been asked to submit a revised clinical trial protocol before the SEC for conducting trial on Covovax vaccine. Developed by Novavax, the vaccine will undergo clinical trials in India and Serum is the partner here.
Meanwhile, Bharat Biotech has been asked to submit the data for consideration again to proceed to Phase 2 clinical trial for its chimpanzee adenovirus vectored Covid-19 vaccine code-named BBV154. Bharat Biotech has to submit revised clinical trial protocol for consideration of the committee.