Covid-19: Randomized trials well under way for hydroxychloroquine and remdesivir
South Dakota announces study today
New York trials began April 1
Both to include 2,000 patients with a controlled placebo
Focused on prevention for those already exposed
Cover photo: The Sanford USD Medical Center, a sprawling complex in Sioux Falls.
By Tatiana Prophet
SIOUX FALLS — Gov. Kristy Noem announced Monday that the state was “going on the offense” and would be partnering with Sanford Health in a randomized, placebo-controlled study of the effectiveness of anti-malaria drug hydroxychloroquine. Doctors have been using the drug across the country on a compassionate basis while the FDA weighs approval.
News outlets reported that the South Dakota study was the first statewide clinical trial, double-blind study in the nation. But New York’s vast NYU Langone Medical Center complex announced a similar study in size and scope on April 1. The New York trial is being conducted in conjunction with the University of Washington in Seattle.
The NYU Langone set of medical buildings, located on First Avenue looking out at the East River, south of the United Nations building.
Separately, another drug Back to Facts has been following since February, Remdesivir, originally developed for Ebola, is getting a placebo-controlled study in New York, at the Albert Einstein College of Medicine’s Montefiore Hospital. The study is in its fourth week, said Dr. Barry Zingman, clinical director of infectious diseases at the hospital.
“At this point, it is still a blinded placebo controlled trial, so we don't know yet if the people who are doing great are getting the sugar solution or if they are doing great because they are getting the anti-viral medicine,” Dr. Zingman said.
All the studies appear to be focusing on the therapies as a prophylactic to prevent contraction of the virus after exposure by health-care workers and high-risk patients (similar to one being conducted currently by the European Union). The hydroxychloroquine studies will take at least 8 weeks, and each study will involve 2,000 patients. NYU will use Vitamin C as a placebo.
Neither announcement mentioned the use of zinc in combination with hydroxychloroquine, but did mention the use of azithromycin as a way to remove “opportunistic bacteria.” (Some concerns have arisen about Z-pack putting heart patients at risk; a doctor on Long Island substituted doxycycline for azithromycin in elderly patients, with positive results).
“We look forward to learning more about the effectiveness of this treatment for COVID-19,” said Susan Hoover, M.D., Ph.D., Sanford Health infectious disease doctor and principal investigator of the North Dakota study. “While this drug has been widely administered in the hope that it can help people, without controlled research studies we aren’t able to say for sure that it really works. Conducting this study allows us to do everything we can to help our patients now, and at the same time gather critical information that will help patients in the coming months and years.”
Hoover said the state has been able to get enough hydroxychloroquine to treat 100,000 patients. The supply came from the Strategic National Stockpile. At the end of March, the department of Health and Human Services began accepting donations of the drug to the stockpile, and a few days later, Sandoz and Bayer together donated a total of 30 million doses.
The New York study, costing $9.5 million, is being funded by the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation in partnership with the Wellcome Trust and Mastercard to speed the identification and testing of potential treatments.
In Los Angeles, placebo-controlled studies of both drugs are also being conducted with patients who are advanced in age and critical.
In other news, The New York Times reported Sunday that a small chloroquine study in Brazil was halted after some patients developed an irregular heartbeat. the headline, however, said nothing about Brazil and misleadingly adds to the aura of doubt around hydroxychloroquine — not even the same medicine. Chloroquine is a harsher drug than its derivative hydroxychloroquine, and shows greater risk to heart function. By contrast, coverage of ongoing or successful studies of hydroxychloroquine have been noticeably absent from The New York Times.
In the following live video on Twitter, I discuss how both Remdesivir and hydroxychloroquine has been shown to terminate many types of viruses including the virus that causes Covid-19. What I didn’t say is that this was shown in vitro and in vivo (with mice). See links to various studies here.
— Back to Facts (@Back2Facts) April 14, 2020
