New York Gov. Andrew Cuomo announced Sunday that New York State has acquired 70,000 doses of hydroxychloroquine, 10,000 doses of zithromax and 750,000 doses of chloroquine to implement drug trials to treat patients with coronavirus, which will begin on Tuesday.
“We’re also implementing the trial drug,” Cuomo said:
We have secured 70,000 hydrocloroquin; 10,000 zithromax from the federal government. I want to thank the FDA for moving very expeditiously to get us this supply.
The President ordered the FDA to move and the FDA moved. We’re going to get the supply and the trial will start this Tuesday. The President is optimistic about these drugs and we are all optimistic that it could work.
I’ve spoken with a number of health officials and there is a good basis to believe that they could work. Some health officials point to Africa, which has a very low infection rate and there’s a theory that because they’re taking these anti-malaria drugs in Africa, it may actually be one of the reasons why the infection rate is low in Africa. We don’t know, but let’s find out and let’s find out quickly. And I agree with the President on that and we’re going to start and we’re going to start Tuesday.
New York City and Westchester County, New York are now the epicenter of the coronavirus pandemic in the United States. As of 10:00 p.m. eastern on Sunday, New York State has reported 15,168 cases. The majority of those cases–more than 10,900–are in New York City and Westchester County.
The death toll in the United States as of 10:00 p.m. eastern on Sunday is now 419, with 114 of those in New York State, 95 in Washington State, and 34 in California.
At a press conference on Thursday President Trump said chloroquine looked promising as a treament for coronavirus, and instructed the Food and Drug Administration to move quickly to move it into clinical testing:White House
Later that day, the FDA issued a statement about chloroquine:
President Trump has directed the FDA to continue its work with the public and private sector to ensure the availability of potentially safe and effective life-saving drugs to patients who are in desperate need, including those infected with COVID-19.
with other government agencies and academic centers that are investigating the use of the drug chloroquine, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19.
On Friday, FDA Commissioner Stephen Hahn told NPR that doctors have the ability to write prescriptions for chloroquine today, because it has been approved for the treatment of malaria, even though clinical trials have not been completed that could lead to its approval for treatment of coronavirus:
And this is an individual doctor decision. We’ll be providing — not we FDA — but the CDC will be providing some guidance about that with respect to potential therapeutic options. But you’re right. I mean, absolutely. And this [chloroquine] is a drug that’s available to physicians to prescribe now. . .
What I’m saying is an individual doctor has to incorporate the data to make the decision for their individual patients. And one of the ways we’re going to try to make this available on a more widespread basis is through this expanded access approach. . .
So we’re working on [when that starts] now where obviously supply and availability of a drug is an issue. But there is an all-of-government approach on this.
Critics of the president claimed his optimism about chloroquine was unwarranted, but two doctors writing in the Wall Street Journal on Saturday said the drug “is showing promise” as a treatment for coronavirus:
A flash of potential good news from the front lines of the coronavirus pandemic: A treatment is showing promise. Doctors in France, South Korea and the U.S. are using an antimalarial drug known as hydroxychloroquine with success. We are physicians treating patients with Covid-19, and the therapy appears to be making a difference. It isn’t a silver bullet, but if deployed quickly and strategically the drug could potentially help bend the pandemic’s “hockey stick” curve.
Hydroxychloroquine is a common generic drug used to treat lupus, arthritis and malaria. The medication, whose brand name is Plaquenil, is relatively safe, with the main side effect being stomach irritation, though it can cause echocardiogram and vision changes. In 2005, a Centers for Disease Control and Prevention study showed that chloroquine, an analogue, could block a virus from penetrating a cell if administered before exposure. If tissue had already been infected, the drug inhibited the virus.
On March 9 a team of researchers in China published results showing hydroxychloroquine was effective against the 2019 coronavirus in a test tube. The authors suggested a five-day, 12-pill treatment for Covid-19: two 200-milligram tablets twice a day on the first day followed by one tablet twice a day for four more days.
TechCrunch reported on Thursday about a French study “conducted from early March to March 16” that indicated chloroquine is promising in the treatment of coronavirus:
A new study whose results were published in the International Journal of Antimicrobial Agents has found early evidence that the combination of hydroxychloroquine, a popular anti-malaria drug known under the trade name Plaqenuil, and antibiotic azithromycin (aka Zithromax or Azithrocin) could be especially effective in treating the COVID-19 coronavirus and reducing the duration of the virus in patients.
The researchers performed a study on 30 confirmed COVID-19 patients, treating each with either hydroxychloroquine on its own, a combination of the medicine with the antibiotic, as well as a control group that received neither. The study was conducted after reports from treatment of Chinese patients indicated that this particular combo had efficacy in shortening the duration of infection in patients.
The patient mix included in the study included six who showed no symptoms whatsoever, as well as 22 who had symptoms in their upper respiratory tract (things like sneezing, headaches and sore throats, and eight who showed lower respiratory tract symptoms (mostly coughing). 20 of the 30 participants in the study received treatment, and the results showed that while hydroxycholoroquine was effective on its own as a treatment, when combined with azithromycin it was even more effective, and by a significant margin.
An National Center for Biotechnology Information study published on March 10 which summarized the research on chloroquine available to that point concluded:
There is rationale, pre-clinical evidence of effectiveness and evidence of safety from long-time clinical use for other indications to justify clinical research on chloroquine in patients with COVID-19. However, clinical use should either adhere to the Monitored Emergency Use of Unregistered Interventions (MEURI) framework or be ethically approved as a trial as stated by the World Health Organization. Safety data and data from high-quality clinical trials are urgently needed
Actor Daniel Dae Kim said over the weekend that treatment with hydrochloroquine helped in his recovery from coronavirus.
The eyes of the entire country will now be focused on results of the trial to treat patients with coronavirus that will begin on Tuesday in New York.