Hope surges around the world as Remdesivir is proving effective against coronavirus.
Optimism is welling up in United States with the promising returns from Remdesivir, an investigational antiviral drug from Gilead Sciences, which is on clinical trials. A Chicago hospital using the drug in the treatment of severe COVID-19 patients has reported rapid recoveries.
About 50 different drugs are on clinical trials for the treatment of COVID-19, including that of the Nigeria team led by Maurice Iwu, a professor of pharmacology and a former chairman of the Independent National Electric Commission, INEC. But it is said that Remdesivir is the most promising for now, showing a potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests.
If the data are conclusive, safe and effective the Food and Drug Administration and other regulatory agencies may issue definite approvals by the end of April. It may become the first approved treatment against COVID-19.
The University of Chicago Medicine recruited 125 people, 113 of which had severe disease with Covid-19 into Gilead’s two Phase 3 clinical trials. They were treated with daily infusions of remdesivir. Only two died; while 123 have been discharged, confirmed said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital, in a video discussion with other University of Chicago faculty members.
Similar trials of the same drug are going on simultaneously in other institutions. “What we can say at this stage is that we look forward to data from ongoing studies becoming available,” Gilead said in a statement last Thursday. Data from the first 400 patients are expected by the end of April. However, the severe trial doesn’t include a placebo group for comparison
Mullane adopts cautious optimism. “It’s always hard, but certainly when we start (the) drug, we see fever curves falling. Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well. Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out 6 to 10 days, maybe three.”
This notwithstanding, the University of Chicago Medicine says “drawing any conclusions at this point is premature and scientifically unsound.” Scientists are hoping to see more data from randomized controlled studies.
Put together, the Gilead trial is investigating five and 10-day treatment courses of remdesivir for a statistical comparison of patient improvement between two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.
The Covid-19 study includes 1,600 patients in 169 different centers globally.
Slawomir Michalak, a 57-year-old factory worker from a suburb west of Chicago, was one of the participants with a severe case of COVID-19. His temperature was 104 with severe shortness of breath when he was admitted on April 4. On his first dose of remdesivir he said, “My fever dropped almost immediately and I started to feel better.”
The next day he could do without oxygen support. He received two more infusions of the drug and was well enough to be discharged on April 7.
“Remdesivir was a miracle,” he enthused.
President Donald Trump in March said remdesivir “seems to have a very good result.”
The stock of Gilead rose by 16 percent at the New York Stock Exchange after the news leaked last Thursday as investors scrambled to take position ahead of the final approval. By Friday it stabilized at eight percent.
Given the political and economic dimensions, there is stiff competition by the advanced countries for the discovery of cure for COVID-19. Most countries want to produce their own indigenous drug for the treatment of the disease. In United Kingdom, the University of Oxford is conducting what has been described as the largest trials of COVID-19 drug involving 5,000 patients in 169 NHS hospitals.
Peter Horby, professor of emerging infectious diseases and global health at Oxford University, who is leading the trials said, “This is by far the largest trial in the world.”
The Recovery team is hoping to be the first to have definitive data. “We’re guessing sometime in June we may get the results,” said Prof Horby. “If it is really clear that there are benefits, an answer will be available quicker.”
However, he cautions, “There would be no magic bullet.”
Nigeria is also in the race for a COVID-19 drug. However, the variables appear to be out the Country’s hand as Prof Iwu’s drug is on clinical trials in United States. Knowing the economic politics of finding the cure, every country may prioritize the products of their own researchers. Iwu has given his formulation to Nigeria and says they know what to do if the death rate becomes much. With the case pushing towards the 1, 000 milestone and 19 deaths already, it may be time for NAFDAC to approve the clinical trial of the formulation in Nigeria for national interest under the principle of “compassionate use.”
If the drug has not met the western scientific standard, it may be licensed as an alternative remedy by NAFDAC so it can go into use to save lives.
And with the testimonies coming from Nigerians at home and abroad on the efficacy of local herbs, it may be time these formulations are formalized for national interventions.