The stage seems set for Nigeria to commence expedited clinical trial of Chloroquine as a possible treatment for the novel corona virus, COVID-19.
This follows the announcement on Monday by the country’s food and drug regulator, National Agency for Food and Drug Administration and Control (NAFDAC) that local drug manufacturer, May & Baker has produced the first batch of the drug meant for the trial.
Chloroquine was discontinued in Nigeria and other parts of the world many years ago for use in malaria treatment because of the resistance that the parasite developed against the drug, making the process of sourcing the Active Pharmaceutical Ingredient (API), chloroquine phosphate for the purpose of clinical trial in COVID-19 treament an initial cause of concern.
Sequel to results of recent experiments by researchers in France and United States where the drug showed efficacy in the treatment of COVID-19 after clinical trials, NAFDAC announced that Lagos State, the epicenter of the virus outbreak, will be starting a clinical trial on chloroquine to evaluate the effectiveness.
Director General of NAFDAC, Professor Mojisola Adeyeye, in the Monday statement after an earlier one issued on March 20, 2020 to that effect said NAFDAC is giving expedited provisional approvals for the manufacture of any commodities for preventing contracting the disease. These include sanitizers, drugs or medical device that could be used for the clinical trial testing and treatment of COVID-19 pandemic.
Consequently, Adeyeye said the Agency had reduced the 120 working days for approval to 10 days due to the crisis. She, however, stated that the products should have been previously reported for clinical trial treatments in reputable scientific journals or technical literature as safe and effective.
Chloroquine, an old antimalarial is being repurposed for the clinical trial treatment of Coronavirus 2019-nCoV. The drug was first tested in vitro (in the lab) using standard assays to measure the effects on the cytotoxicity, virus yield and infection rates of COVID-19. The drug was reported to function as antiviral at both the entry and post-entry stages of COVID-19 infection. Chloroquine has also recently been reported as potential broad spectrum antiviral drug.
Citing recent publication, the NAFDAC DG said Chloroquine was reported in a press briefing by the State Council of China, indicating that chloroquine phosphate had demonstrated marked efficacy and acceptable safety in treating COVID-19 associated pneumonia in a multi-center clinical trials conducted in China in a study that involved 10 hospitals in Wuhan, Jingzhou, Guangzhou, Beijing, Shanghai, Chongqing and Ningbo, and 100 patients.
“The investigators reported that chloroquine phosphate is superior to the control in inhibiting the pneumonia associated with COVID-19, and shortening the course of the disease,” Adeyeye noted in the statement.
Speaking on the path to the impending clinical trial in Nigeria, she said, “About four weeks ago, I approached a local manufacturing company (May and Baker), a member of Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria (PMGMAN), 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 antimalarial many years ago before the discontinuation. The Managing Director expressed possible difficulty in getting the API due to the fact that the drug has been discontinued.
“He called shortly after that he was able to get the API and was asked to manufacture a batch for emergency stock just in case more people become exposed and infected with the virus. The batch has been manufactured and the company plans to make more batches if needed.”
Chloroquine works by increasing endosomal pH from the acidic environment required for virus/cell fusion, resulting in the inhibition of infection of SARS-CoV. It also interferes with the glycosylation of cellular receptor, angiotensin-converting enzyme 2. This may inhibit the virus-receptor binding and terminate the infection. The antiviral and anti-inflammatory effects of chloroquine contribute to the efficacy in treating COVID-19 patients.
However, NAFDAC has advised the public to desist from its use without the guidance of a medical doctor or clinician for cases of clinical trial treatment of COVID-19. This is to guide against such side effects as gastrointestinal upset, blurred vision, headache and pruritis (itching), which can be relieved by using antihistamine. Prolonged use can also cause retinopathy or vision impairment.
“The Agency, through her regulatory activities will ensure that the clinical trial protocol guidelines are followed and wishes the clinical research teams great success in stopping the raging pandemic,” Adeyeye stated.