American Medical Doctors Recommend Early COVID-19 Treatment Combining Hydroxychloroquine, Azithromycin & Zinc

A group of medical doctors in the US, comprising Ben Kaplan Singer, M.D.; Avery J. Knapp Jr., M.D.; Kat Toups, MD, DFAPA; Daniel Stickler, M.D. and other contributing doctors, released on April 11 a document titled “Immediate Treatment for Early Stage SARS-CoV-2 Infections Recommended To Be Implemented Nationally Starting Now.” The document is presented as “A strategic principle and practical approach to rapid response to novel pandemics.”

The initiative has been 3 weeks in the making. “For the past 3 weeks myself and a team of researchers have worked round the clock to synthesize the available research on treating COVID-19 with hydroxychloroquine, zinc, and azithromycin. We realize this is a controversial subject, but there is a compelling need to disseminate quality information on the benefits of early treatment in patients at risk of hospitalization.” reads Dr Kaplan Singer’s FB page.

He also mentions: “We will update this information regularly as new research emerges. We are collecting physician signatures to support this important and potentially life-saving treatment. Please share.”

As a preamble to the document, the authors indicate: “There will always be an argument for more research and for better data, but waiting for more data is often an implicit decision not to act or to act on the basis of past practice rather than best available evidence. The goal must be actionable data — data that are sufficient for clinical and public health action that have been derived openly and objectively and that enable us to say, ‘Here’s what we recommend and why.’”

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The complete document can be found at: https://docs.google.com/document/d/1ka76CL50hR_a0b5oIhEAVY4gfyqkJcBxXBcP0r2nrz0/edit?usp=sharing

Here are key excerpts:

BOTTOM LINE: Our primary strategic objective must be to prevent ICU overwhelm, which on our current course is imminent in most states.  It is an axiom of infectious diseases that treatment in earlier stages is more effective than treating advanced stages. Early COVID-19 treatment is more likely to prevent disease progression to critical status, radically lowering hospitalizations and CFR than inaction. Current clinical drug trials are mostly focused on treating late stages of disease, when immunologic damage is a dominant threat.  We believe that trials should focus on earlier stage infection to prevent progression to advanced disease.  Given the suggestion of efficacy of hydroxychloroquine (HCQ), and the imperative to treat disease before it progresses to cytokine storm, we believe that the current data are sufficient to recommend FDA provisional approval for early outpatient treatment of COVID-19 with HCQ plus zinc and azithromycin. This triple combination treatment can be modified where needed in patients with prolonged QTc or other contraindications at the physicians’ discretion  Following this same rationale, we recommend that other clinical trials involving drugs that have already been approved for non-COVID-19 diseases, and for which the safety profile is well understood and reasonably acceptable, should begin clinical trials on patients in early stages of COVID-19 disease, alongside patients with more advanced disease.

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WHEN & WHO TO TREAT: Clinical and in vitro data suggests greatest value is in treating early, similar to other antivirals used for influenza and herpes simplex, and corresponding to nearly universal findings in treating nearly every type of infection. Early clinical reports suggest it’s best to treat within 5 days of symptom onset. Waiting until a patient is hospitalized or critically ill is unwarranted and unwise.

TREATMENT: 

  • HCQ: 6.5-15mg/kg PO in divided loading dose followed by 400-1000mg/day in divided doses for 4-9 days 
    • Obtain baseline EKG for QTc, check on day 3 (or remote monitoring of QTc)
    • Check Metabolic Panel for hypokalemia, Magnesium, Liver Function Tests
    • For patients with history of long QT syndrome or renal failure, consult with cardiologist
  • Zinc: use zinc acetate or gluconate lozenges with minimal excipients and flavorings to provide 18-25mg of ionized zinc taken every 4 hours during days on HCQ
  • Azithromycin: 500mg PO on day 1 followed by 250mg for 4 more days

The document features a detailed research summary, as well as detailed safety and precautions, and concludes as follows: 

“Base treatment is to start early in patients with risk factors and/or concerning symptoms, using HCQ with zinc and azithromycin. In cases where there is concern for QTc prolongation, we recommend detection and correction of hypokalemia and/or hypomagnesemia, treating only with HCQ and zinc, with consideration of consultation with a cardiologist, and follow-up EKG on day 3. If zinc is unavailable, proceed to treat patients with just HCQ, as it has been noted to have meaningful effects on its own. However, given mechanisms of action and some clinical data, HCQ appears most effective when combined with zinc and azithromycin.”  

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As of writing this article, on April 18, there were 65 medical doctors having signed the document.

Find the list of signatories at: https://coda.io/@covid-19-initiative/immediate-treatment-early-stage-sars-cov-2

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