Study: Treatment with hydroxychloroquine cut death rate significantly in COVID-19 patients

In a followup to our coverage of COVID-19 treatments, a new study published recently by Henry Ford Health System shows that treatment with hydroxychloroquine cut the death rate significantly in sick patients hospitalized with COVID-19 – and without heart-related side-effects.

The news comes after earlier studies that raised alarms about the safety of hydroxychloroquine were retracted by The Lancet and The New England Journal at the request of the authors of the studies due to flaws.

Closeup of COVID-19 coronavirusAccording to the U.S. Centers for Disease Control & Prevention, hydroxychloroquine (also known as hydroxychloroquine sulfate) is a U.S. Food & Drug Administration (FDA)-approved arthritis medicine that also can be used to prevent or treat malaria. It is available in the United States by prescription only. The drug is sold under the brand name Plaquenil and it is also sold as a generic medicine. It is commonly used by patients with arthritis, lupus or other rheumatic conditions.

In a large-scale retrospective analysis of 2,541 patients hospitalized between March 10 and May 2, 2020 across the system’s six hospitals, the study found 13% of those treated with hydroxychloroquine alone died compared to 26.4% not treated with hydroxychloroquine. None of the patients had documented serious heart abnormalities; however, patients were monitored for a heart condition routinely pointed to as a reason to avoid the drug as a treatment for COVID-19.

The study was published last week in the International Journal of Infectious Diseases, the peer-reviewed, open-access online publication of the International Society of Infectious Diseases.

Patients treated with hydroxychloroquine at Henry Ford met specific protocol criteria as outlined by the hospital system’s Division of Infectious Diseases. The vast majority received the drug soon after admission; 82% within 24 hours and 91% within 48 hours of admission. All patients in the study were 18 or over with a median age of 64 years; 51% were men and 56% African American.

“The findings have been highly analyzed and peer-reviewed,” said Dr. Marcus Zervos, division head of Infectious Disease for Henry Ford Health System, who co-authored the study with Henry Ford epidemiologist Samia Arshad. “We attribute our findings that differ from other studies to early treatment, and part of a combination of interventions that were done in supportive care of patients, including careful cardiac monitoring. Our dosing also differed from other studies not showing a benefit of the drug. And other studies are either not peer reviewed, have limited numbers of patients, different patient populations or other differences from our patients.”

Zervos said the potential for a surge in the fall or sooner, and infections continuing worldwide, show an urgency to identifying inexpensive and effective therapies and preventions.

“We’re glad to add to the scientific knowledge base on the role and how best to use therapies as we work around the world to provide insight,” he said. “Considered in the context of current studies on the use of hydroxychloroquine for COVID-19, our results suggest that the drug may have an important role to play in reducing COVID-19 mortality.”

The study also found those treated with azithromycin alone or a combination of hydroxychloroquine and azithromycin also fared slightly better than those not treated with the drugs, according to the Henry Ford data. The analysis found 22.4% of those treated only with azithromycin died, and 20.1% treated with a combination of azithromycin and hydroxychloroquine died, compared to 26.4% of patients dying who were not treated with either medication.

“Our analysis shows that using hydroxychloroquine helped saves lives,” said neurosurgeon Dr. Steven Kalkanis, CEO, Henry Ford Medical Group and Senior Vice President and Chief Academic Officer of Henry Ford Health System. “As doctors and scientists, we look to the data for insight. And the data here is clear that there was benefit to using the drug as a treatment for sick, hospitalized patients.”

Overall, hospital system patients in the study experienced an 18.1% in-hospital mortality rate. Regardless of treatment, mortality was highest in:

• Patients older than 65,
• Patients who identified as Caucasian,
• Patients admitted with reduced oxygen levels,
• Patients who required ICU admission.

Patients who died commonly had serious underlying diseases, including chronic kidney and lung disease, with 88% dying from respiratory failure. Globally, the overall mortality from SARS-COV-2 is estimated to be approximately 6% to 7%, with mortality in hospitalized patients ranging between 10% and 30%, according to the study. Mortality as high as 58% has been seen among patients requiring ICU care and mechanical ventilation.

Dr. Zervos also pointed out, as does the paper, that the study results should be interpreted with some caution, should not be applied to patients treated outside of hospital settings and require further confirmation in prospective, randomized controlled trials that rigorously evaluate the safety and efficacy of hydroxychloroquine therapy for COVID-19.

“Currently, the drug should be used only in hospitalized patients with appropriate monitoring, and as part of study protocols, in accordance with all relevant federal regulations,” Dr. Zervos said.

Henry Ford Health System, as one of Michigan’s major academic medical centers with more than $100 million in annual research funding, is involved in numerous COVID-19 trials with national and international partners.

Henry Ford Health System is currently also involved in a prophylactic hydroxychloroquine study: “Will Hydroxychloroquine Impede or Prevent COVID-19,” or WHIP COVID-19. The study is a 3,000-person, randomized, double-blinded look at whether hydroxychloroquine prevents healthcare and frontline workers from contracting the COVID-19 virus. The WHIP COVID-19 team is working on expanding study sites while there is a lull in the number of COVID-19 cases in Southeast Michigan. This is in preparation for a potential increase of COVID-19 cases as Fall flu season approaches, with additional sites available for convenient enrollment of healthcare workers and first responders. The WHIP COVID-19 team is also taking this gift of time to reach out to other areas of the world that are seeing a blossoming of cases: Brazil and Argentina. There are currently 619 people enrolled in the study, out of a target of 3,000.

MacDailyNews Take: Until we get a vaccine, this study’s finding is obviously very promising news of an effective treatment for COVID-19. The existence of such treatments helps everyone, of course, not to mention the macroeconomy and certainly Apple, which currently has a number of retail stores closed in various locations due to COVID-19 outbreaks. Good news on COVID-19 treatments is good news for people, for the economy, and, ultimately, for Apple.

[Thanks to MacDailyNews Readers too numerous to mention for the heads up.]

69 Comments

  1. Before everyone starts going crazy, there was a lot wrong with this study (hence the reason it was published in a pretty low ranking journal), most notably that it was an observational study, included a mixture of treatments (important point), excluded individuals not yet discharged, non-randomly assigned patients to different treatments, and was over a 2-3 months period during which they got better at treating patients. The mixture of treatments is important, since the hydoxychloroquine group also received steroid treatment at a higher rate than the other groups; and the Oxford trial just demonstrated a significant effect of steroids on survival – particularly in the most high risk patients. The gold standard approach is an RCT, of which there has been at least 3, all of which were stopped early because death rates were higher in the hydoxychloroquine group compared to placebo or other treatment. Currently, this is an outlier study. It would be fool’s gold to suddenly think hydoxychloroquine is the cure all. Even the authors note it isn’t. Let’s stop bashing people (liberal or conservative), this is science in action.

    1. “…there was a lot wrong with this study (hence the reason it was published in a pretty low ranking journal),…”
      That is a false conclusion that cannot be drawn from your premise. It could easily be because it was a study and not a clinical trial, as such many journals do not publish studies.

      ” Let’s stop bashing people (liberal or conservative), this is science in action.” I agree on BOTH counts… people should not be bashed simply for sharing ideas…challenge the ideas with sound arguments, not attacking people

      …and this is what science looks like…sharing ideas, no matter what it looks like, to stimulate conversation to try to gain insights, then testing them out and sharing results for open review and discussion.

      It has been said that it often takes at least 10 “bad/invalid/incorrect/unsuccessful” ideas to come up with one “good/valid/correct/successful” one. If you stop the 10+, you may never find the “one”.

  2. This is bittersweet news. The US has managed to politicize HCQ for reasons that are not clear. The Chinese had been using it and based on their results Prof Didier Raoult of Marseille used HCQ and Azithromycin early n the infection, when the virus is still a factor. The US insisted on waiting for the results of placebo controlled randomized studies (double blind) before acting. This has been the core of the issue. Do you insist that only these sorts of experiments are the only kind to provide evidence. Those brought up in the statistical design of experiments approach, with quite frankly a debate knowledge of the foundations of the subject, have adopted it for medical experiments, even during epidemics. It is not something I agree with and so much evidence that it worked fairly well in the early stage was discarded. The clinical designs were inflexible, used virtually toxic levels of HCQ and due to the complexity of setup inevitably were mostly applied too late. Results then needed analysis adding yet more delay. Even the well publicized Henry Ford Detroit study assigned HCQ+Azithromycin to later cases, which is why the results for that combination were worse than HCQ alone. As far as I know , none included zinc. The approach promoted by Dr Fauci and company has disturbing points in common with the AZT trials for Aids in the 1980’s. People should be disturbed, and it should have had nothing to do with your election year politics. Raoult was using this before Trump even mentioned it. It’s all so sad. The parallels with what the HIV infected community of the 1980’s are truly disturbing. Hopefully, Americans will have a second look at how patient care and rights are controlled. It’s so upsetting.

      1. Ah, shoot from the hip. That’s your style isn’t it? H8te first and then later on, h8te some more, then h8ayt again? C’est enmerdent, comme toi, petit pomme-de-terre.

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