Posted by E.L.E.X on May 09 2020 under News
This is sequel to the approval by the National Agency for Food and Drug Administration and Control that chloroquine could be used for the clinical trial treatment of the deadly disease.
There were 386 new cases on Friday, pushing the total cases in the country to 3,912. The number of deaths increased to 117 while 679 persons have been discharged so far.
The state Commissioner for Health, Prof Akin Abayomi, said at a media briefing in Ikeja on Friday that there would be three arms of the trial, capturing treatment, prevention and care for high-risk individuals, like elderly persons with underlying ailments such as hypertension, diabetes, and obesity.
Findings by Saturday PUNCH revealed that the state submitted its final protocol to NAFDAC on Thursday evening as it awaits the approval of the agency in preparation for the commencement of the hydroxychloroquine clinical trial treatment next week.
NAFDAC, which approves medicines meant for clinical trials, had on March 20 approved the use of chloroquine for clinical trial treatment of the novel disease, warning however that the approval was not for the drug to be used as a treatment for the virus.
The Director-General, NAFDAC, Prof Mojisola Adeyeye, also confirmed to Saturday PUNCH a few weeks ago that only Lagos State, which has the highest number of cases and is the epicentre of the virus in the country, had signified interest in using the drug for a clinical trial to find treatment for the virus.
And in a recent interview with one of our correspondents, the DG said the state government had sent its protocol to NAFDAC for final approval which would allow it to begin the clinical trial.
“For a clinical trial, you will have to write a protocol and Lagos State submitted its protocol to us. We vetted it back and forth and now they are about to start. It has to be well designed because whatever comes to the scientific world must be defensible. That is the essence of clinical trial treatment planning.
“It has to be well thought out. How many patients will give us a statistical result that will be interpreted well and give a level of confidence? So, these are the kinds of things that go into a clinical trial protocol. We have come alongside Lagos State to review their protocols and they are about to start.”
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