The Lagos State Government has said it will commence chloroquine clinical trial for the treatment of the novel coronavirus disease within the next one week or thereabouts.
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 epicenter 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.
She said, “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.”
However, the commissioner said on April 7 that the state had concluded plans to start COVID-19 clinical trial in partnership with the Nigeria Centre for Disease Control and other institutions.
Meanwhile, addressing journalists on Friday, Abayomi said the clinical trials were coming at the most appropriate time given the number of cases the state had been recording in recent times. He noted that the state would use hydroxychloroquine produced by original manufacturers and not the generic one and that the state was set to receive “thousands and thousands of the tablets.”
The number of cases in the state rose by 176 on Friday to 1,667.
He said, “To put together a clinical trial is a very difficult thing; there are people that specialize in clinical trial research. We have to perform the clinical trial in such a way that we would be able to get a very clear result out of it and it won’t have any bias.
“We are planning almost three arms of the hydroxychloroquine trial; one arm of the trial would be for treatment. In other words, if you present with COVID-19 and you test positive, does hydroxyl chloroquine improve your chances of not dying from it or does it shorten the amount of time between when you are diagnosed and when you are cleared of the virus and you are ready to be discharged?
“We are also using it as prevention. For example, if you want to test, when you give the hydroxychloroquine to the health care professionals as prevention, does it protect them from getting infected by COVID-19?
“We also want to use it among people in the communities who have high risk. For example, somebody who is over the age of 70 with hypertension, diabetes or obesity, we know that if you have COVID-19, you are at risk of developing severe to critical symptoms, so if we give members of the public on this clinical trial access to the original hydroxychloroquine, we will protect certain high risk persons from developing or contracting COVID-19.
“These are the arms we are developing in our clinical trial strategy. There is a lot happening around this activity and I think within the next week or so, we would have commenced the trials.”
The commissioner noted that it needed NAFDAC’s permission, ethics approval and recruitment of the participants in the trial.
He added, “As I said, we are still in the early part of the outbreak, so we have a long way to go and the trials are coming in at a time we feel the most appropriate; when we are seeing at least 100 cases a day. It will be easy for us to perform those clinical trials with the number of cases that we are seeing.”
State may record 120,000 cases by July – Health commissioner
Meanwhile, the Lagos health commissioner said at the briefing that the state might record between 90,000 and 120,000 confirmed COVID-19 cases by July or August, the period he said the state was estimated to reach its peak.
He stressed that the figure was a mere projection and there was no certainty that the cases would rise to that, adding that the cases would have reached 6,000 cases by now but for the strategies deployed by the government to contain the spread of the virus.
He said, “Just a month ago, on April 7, we saw 10 cases per day. Two weeks later, it was 32, then 70 cases. We are now seeing above 100 cases per day. This shows our graph is moving in a gentle incline upwards.
“We definitely have not reached the peak of our outbreak. We suspect that the peak will happen sometime in July or August and so we are preparing for the oncoming; we are increasing our capacity and strategies to deal with this situation.
“Our model suggests that by July, we are going to see somewhere between 90,000 and 120,000 positive cases. However, our testing algorithms only test for people who have developed symptoms.”
Abayomi, who said the state recorded its highest number of infections on May 7 with 183 cases, noted that the increase in the cases was due to the decentralized sample collection in the 20 local government areas of the state while the testing centers had also increased to four.
He said increased cases had been recorded in Alimosho, Oshodi/Isolo and Ikeja local government areas, noting that only three per cent of the confirmed cases in the state were severe while the remaining 97 per cent had mild symptoms.
…faults evasion by suspected cases
The commissioner also complained that the state was facing the challenge of confirmed COVID-19 cases fleeing their homes before the ambulance got there to pick them up. He noted that the earlier such persons submit themselves and commence treatment, the higher their chances of survival.
Responding to a question on the reason for the discrepancy between the number of active cases and occupancy in the state, he said, “When we test people, we sometimes find it difficult to find them in their apartment and they don’t answer their call.”
He said the state’s isolation centers were “very comfortable” and that there was nothing to worry about.
The Minister of Health, Dr Osagie Ehanire, said on Friday at the daily briefing of the Presidential Task Force on COVID-19 in Abuja that the Federal Government would dispatch its technical teams to validate the claims by Kogi and Cross River states that they did not have COVID-19 cases.
He said the initial team dispatched to Kogi had a failed mission because of “some differences” with the state authorities but that a fresh engagement would be carried out.
Ehanire said, “Kogi State is one of the two states that have said that they do not have COVID-19 patients. They seem to be sure of this. So, the agreement we have had with them after discussion with the governor is that we shall send a team in just to validate that fact and engage the authorities.
“Of course, we do that for national records and to be able to report to the world the situation in our country. We tried to send a team into Kogi on Thursday but there were some differences there. So, we need to engage the state governor again and state some conditions within which the ministry and NCDC can complete their jobs. We are going to send a team to Cross River next week also.”
The minister in his address also noted that a technical team deployed to Kano State by the ministry had trained 100 ambulance drivers and patient handlers as part of efforts in tackling the ravaging COVID-19 pandemic.
The minister said the government was also making efforts to build the “expertise of critical care doctors and nurses to utilize ventilators and other appliances being allocated to intensive care hospitals nationwide.”
He added, “A ministerial technical team comprising of various specialists was set up and deployed to Katsina State to assess the situation and report on needed support. Also, calm has been restored in the Gombe State isolation centres.”
The minister also said government’s team was in Jigawa State on a fact-finding mission as the state battled with repatriated Almajirai, “of whom many have tested positive for COVID-19.”
Ehanire said, “On Friday morning, we deployed a multi-sectoral technical team on a fact-finding mission to Jigawa State at the request of the state governor. The challenges in Jigawa revolve around repatriated Almajiris, of whom many have tested positive for COVID-19.
“The team includes doctors and nurses, who will support the state Ministry of Health in setting up and accrediting their isolation and treatment centres.”
The Chairman of the Presidential Task Force on COVID-19 and Secretary to the Government of the Federation, Boss Mustapha, lamented that the isolation centres in states were fast running out of bed space due to the upsurge in the number of confirmed cases.
“We have also received reports from the states, which suggest that the treatment centres are running out of bed spaces,” he added.
Speaking at the daily briefing on Friday, he said the task force was also considering viable alternative treatment.
“At the appropriate time, the guidelines and protocols shall be unfolded,” he added.
Mustapha said the PTF after a meeting with security agencies on Friday arrived at new measures to aid the strict enforcement of the guidelines earlier announced for the interstate lockdown.
He said all persons on essential duties, including journalists and medical personnel, should always carry authentic means of identification, while noting that security agents should always respect the fundamental rights of citizens during enforcement.
He added, “Security agencies should improve monitoring of their personnel and interaction with the citizenry; citizens should respect the sacrificial role of security agencies and desist from assaulting security personnel and damaging security infrastructure.”
He said it was agreed that appropriate personal protective equipment and related protective gears would be provided for security personnel, noting that enlightenment and awareness would be intensified.
The SGF said the increasing number of cases was due to the increased testing capacity.
He added, “However, this increased testing does not translate to higher fatality rates as in the last few days, we have witnessed a good number of discharges and a continually reducing daily fatality rate.”
He also said the PTF was liaising with the Task Force on movement of agricultural produce under the leadership of the Minister of Agriculture and Rural Development, Sabo Nanono, in order to ensure that food scarcity was not experienced in any part of the country.
The SGF debunked insinuations that states were not operating a uniformed policy on the COVID-19. He said, “The national response is one but we are mindful that we are a federation; there can be differences in implementation which states can modify. The basis of application can vary from state to state like time to go to the market and business hours.”
He said there was no known single cure for COVID-19 as the world was still battling to evolve a vaccine and drug.
Also at the briefing, the PTF National Coordinator, Dr Sani Aliyu, expressed concerns about states disregarding new measures introduced to relax the lockdown.
He said places of worship and schools remained closed and that there should be no mass gathering of persons above 20. “It seems we are going to the exponential stage of the disease,” he added.
He added that the task force would continue to work with state governments on the implementation of the relaxed guidelines.
Aliyu called on philanthropists to support the government with accommodation for those placed under observation in order to address the shortage of bed space at isolation centers.
Governor Babajide Sanwo-Olu said on Friday that 42 more persons, comprising 22 males and 20 females, all Nigerians, were discharged from the isolation centers in the state, bringing the total number of discharged persons in the state to 448.
He said the patients, 32 from Landmark isolation Centre in Eti-Osa; eight from Lekki and two from Onikan isolation Centre, were discharged having fully recovered and tested negative twice.