Coronavirus: 11 states, FCT shun chloroquine clinical trial – NAFDAC

Weeks after the National Agency for Food and Drug Administration and Control approved the use of chloroquine for the clinical trial treatment of the coronavirus disease, states affected by the wide-spreading virus have yet to signify interest to embrace the initiative, Saturday PUNCH has learnt.

The Director General of the agency, Prof Mojisola Adeyeye, on Friday told Saturday PUNCH that only Lagos State, which has 109 confirmed cases, the highest in the country, had signified interest in using the drug for clinical trial to find treatment for the virus.

The other states that have recorded cases are Osun (22 cases); Oyo (eight); Akwa Ibom (five); Ogun (four); Edo (seven); Kaduna (four); Bauchi (three); Enugu (two); Ekiti (two); Rivers (one); Benue (one) and Ondo (one), which was confirmed on Friday evening, and the Federal Capital Territory with 41 cases.

As of Friday evening, the number of confirmed cases in Nigeria stood at 210, out of which 25 patients had been discharged in Lagos and Ekiti states, while four deaths have so far been recorded. The two new deaths confirmed on Friday were in Lagos and Edo states. Across the world, the number of cases had risen to 1,093,887 cases, out of which 228,037 had recovered and 58,752 had died.

NAFDAC, which approves medicines meant for clinical trials, had on March 20 approved the use of chloroquine for clinical trial, warning however that the approval was not for the drug to be used as treatment for the virus.

The DG had said, “NAFDAC is not approving chloroquine as a product that can be used for coronavirus because there is no submission to us for registration, but because it is under clinical trials, NAFDAC approves medicines meant for clinical trials. Therefore, the medicine is being approved just for the clinical trials.”

NAFDAC’s approval came about three years after the Federal Government in 2017 banned the use of chloroquine and artemisinin monotherapy used in the treatment of malaria in the country.

The then Minister of Health, Prof Isaac Adewole, announced the ban during the World Malaria Day in 2017, stating that, “Doctors and nurses have been told that chloroquine is no longer useful and that it is wrong to prescribe artemisinin monotherapy.”

But responding to enquiries on whether states have applied to the agency for clearance to commence the clinical trial, Adeyeye said, “I know that Lagos State has signified interest and the clinical trial is about to start.

“Lagos is prepared. And it is only Lagos that I am aware of. I have not heard of any other institution or hospital.”

When asked if the exercise would involve real patients or just mere volunteers, the NAFDAC boss said, “It is clinical trial treatment we are referring to here. And it is done on the patient, unlike ordinary clinical trial which relies on volunteers.

“Clinical trial treatment includes treatment of patients. So, Lagos has the highest number of cases and Lagos is where it will be set up.

“And they are about to finish setting it up because there should be an approval. NAFDAC has to monitor it. No exact date for Lagos State but it is going to be very soon.”

Confirming the readiness of Lagos State for the clinical trial, the state Commissioner for Information, Mr Gbenga Omotoso, told one of our correspondents on Thursday that the government was working on it.

He said, “Work is ongoing on the clinical trial and once they find it to be okay for treatment, either the NCDC or the Commissioner for Health would announce it. However, the health commissioner had confirmed that the process had begun.”

Meanwhile, further to the approval of the drug for clinical trial, the NAFDAC DG on Monday ordered the manufacturing of chloroquine for emergency stock for possible clinical trial treatment of coronavirus.

She said in a statement that the drug was reported to function as anti-viral at both the entry and post-entry stages of 2019-nCoV infection, adding that chloroquine had also been reported as potential broad spectrum anti-viral drug.

She added, “About four weeks ago, I approached a local manufacturing company (May and Baker), a member of Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria, whose flagship product in the past was chloroquine, to make a batch of the drug for emergency stock. The company had NAFDAC approval for the production of the drug as anti-malarial many years ago before the discontinuation.”

According to Adeyeye, despite initial difficulty expressed by the managing director of the company, the hurdle was later cleared, leading to the production of the drug, with more to be manufactured. – Punchng.com

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