The Lagos State Government says its proposed clinical trial of chloroquine in the management of COVID-19 will commence before this weekend.
However, the Nigeria Medical Association says the clinical trial could span six months or more, depending on the approach.
Recall that the National Agency for Food and Drug Administration and Control had said Lagos State would pioneer the clinical use of antimalarial drug, chloroquine, in the management of the COVID-19 global pandemic.
The agency said on March 30 that it had ordered the manufacture of the drug for emergency stock for possible clinical treatment of COVID-19 patients.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, in a statement disclosed that a local manufacturing pharmaceutical company, May & Baker, had been approached to produce the medication.
Adeyeye added that M & B, whose former flagship product was chloroquine, had produced a batch of the drug for emergency stock for the treatment of COVID-19.
She said Lagos State would start a clinical trial of the drug to evaluate its effectiveness.
Reiterating the information, on April 7, the state’s Commissioner for Health, Prof. Akin Abayomi, said Lagos had concluded plans to start choloroquine clinical trial in partnership with the Nigeria Centre for Disease Control and other institutions.
“We have secured approval and everything we need in readiness for the chloroquine clinical trial.
“The documentation has also been completed. Hopefully, we should be ready for the trial before the end of this weekend,” he said.
He, however, declined to comment on the likely duration of the project or how much it would cost.
“We don’t consider money first before embarking on a project that will be beneficial to Lagosians.
“All I can say is that we are ready,” he stated.
However, speaking with our Correspondent, president of the Nigerian Medical Association, Dr. Francis Faduyile, said a standard clinical trial could take six months, a year or more to complete, depending on the approach.
“I am not privy to the kind of clinical trial on chloroquine Lagos is trying to conduct.
“But, depending on the protocol or methodology, it can take a minimum of six months,” he said.
Faduyile explained that clinical trial is a complex process that involves getting patients, administering the medication, observation and analyses before researchers can declare their results.
Faduyile believed why clinical studies are not being taken seriously today was because of bogus statements from ‘charlatans.’
“Unfortunately, we have all sorts of charlatans in the position of leadership and government.
“That’s why a President (Donald) Trump can tell people to take disinfectants for COVID-19 treatment,” he said.
On patients or volunteers required for such research, the NMA president said they were usually in large numbers and must be people who are currently infected with COVID-19.
“A lot of things have to be taken into consideration. It is not possible to run with just five or 10 patients.
“Among other things, the trial must comprise male, female and possibly, children, whose health status must be defined.
“To conduct standard research, you have to bring your bias to a minimum level.
“That’s why I said clinical trial is a complicated process,” Faduyile said.
It may be recalled that on April 3, NAFDAC had expressed concerns that states, including the Federal Capital Territory affected by the virus, were not accepting to assent to the clinical trial of chloroquine as treatment for COVID-19.
Adeyeye said only Lagos State, which then had 109 confirmed cases, had signified interest in using the drug for clinical trial to find treatment for the virus.
In the same vein, Director General of Nigeria Institute for Medical Research, Prof. Babatunde Salako, recently told our Correspondent that clinical trial is an expensive project that demands ample funding.
“There are issues here and there. I cannot speak for Lagos State and NAFDAC, but what we are doing here at NIMR.
“What is important is funding. We are trying to raise enough fund to start off the trial at some point.
“It is not that easy rushing to undertake a clinical trial. There are procedures to follow.
“Initially, we wanted a national clinical trial that would factor in the six geo-political zones. But that may gulp about N200m and we don’t have such money.
“As it stands, we may have to start small. As I mentioned earlier, the major challenge is funding,” he had said.
The World Health Organisation defines clinical trial as a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.
It is carefully designed, reviewed and completed, and need to be approved before commencement.
It is a trial that people of all ages can take part in, including children. Among other things, it has four phases of biomedical clinical trials.
Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved.
Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer time frame.
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