Why we need a clinical trial of hydroxycholoroquine, azithromycin, and zinc ASAP

A preliminary study done by New York's Grossman School of Medicine reports on the use of HCQ+AZT+Zinc versus HCQ+AZT alone in four New York Hospitals has issued its report. Here's the key finding of the abstract.

Zinc sulfate increased the frequency of patients being discharged home, and decreased the need for ventilation, admission to the ICU, and mortality or transfer to hospice for patients who were never admitted to the ICU.  After adjusting for the time at which zinc sulfate was added to our protocol, an increased frequency of being discharged home (OR 1.53, 95% CI 1.12-2.09) reduction in mortality or transfer to hospice remained significant (OR 0.449, 95% CI 0.271-0.744).  Conclusion: This study provides the first in vivo evidence that zinc sulfate in combination with hydroxychloroquine may play a role in therapeutic management for COVID-19.

The "main finding of this study is that after adjusting for the timing of zinc therapy, we found that the addition of zinc sulfate to hydroxychloroquine and azithromycin was found to associate with a decrease in mortality or transition to hospice among patients who did not require ICU level of care, but this association was not significant in patients who were treated in the ICU."

Here are the statistics:

Discharged home:

  • Zinc, 317 (77.1%) No Zinc 356 (68.3%)
  • Needed ICU Zinc: 38 (9.2%) No Zinc 82 (15.7%)
  • Needed Invasive Ventilation Zinc 33 (8.0%) No Zinc 86 (16.5%)
  • Expired/Hospice Zinc 54 (13.1%) No Zinc 119 (22.8%)
  • Expired/Hospice (Patients needing ICU) Zinc 28 (73.6%) No Zinc 61 (74.4)
  • Expired/Hospice (Non-ICU Patients) Zinc 26 (6.9%), No Zinc 58 (13.2%)

Why do we need a clinical trial of HCQ+AZT+Zinc?

It may cut ICU visits by 40%
It may halve the need for ventilation.
And it may cut the death rate by almost 50%.

Let's try a thought experiment.  Suppose the government launches a full-scale clinical trial of HCQ+AZT+Zinc, perhaps as a control group in the currently ongoing South Dakota or University of Washington clinical trials.  (The latter is already testing HCQ+AZT but not zinc.  To date, outside the Grossman report, I have seen trials testing only one or both of the first two drugs.)  Let's also assume that one or both of these clinical trials do test HCQ+AZT+Zinc on early stage patients and their early results (as of June 15) echo those found in the anecdotal reports of Dr. Armstrong, who saved 39 of 39 patients at a Texas nursing home using this therapy, and Dr. Zelenko, who reported treating 1,450 patients, of whom 405 were high-risk (over 60 with symptoms, under 60 with no symptoms but with an underlying chronic medical problem, as well as anyone who looked sick or had difficulty breathing).  These patients were treated immediately on first presentation with HCQ+AZT+Zinc — without waiting for test results.  "Statistically," Dr. Zelenko says, "out of that number, you would have expected 20 dead, and a multiple of that, perhaps 30 or 40, on a respirator."  But only nine of Dr. Z's patients were admitted to hospital.  Five had pneumonia, and they quickly recovered and returned home.  Four were temporarily on respirators before recovering.  Only two patients died.  None of these patients experienced any side effects during treatment.  The remaining 1,045 patients were low-risk (defined as under 60 with no symptoms and no chronic medical problems such as cancer, diabetes, high blood pressure, things like that), and they were not treated with this therapy and recovered on their own.

If a clinical study of HCQ+AZT+Zinc confirms Dr. Z's results, the president will need to make some decisions fast.  Here's why: 

The history of the Spanish flu epidemic of 1918 suggests that the virus could wane over the summer months and roar back in the fall.  For the sake of simplifying the math, let's assume that Dr. Zelenko treated only 1,000 patients and adjust all his findings proportionately.  In this scenario, he would have had 279 high-risk patients needing the therapy.  Of these, six would have needed to visit the emergency ward for a time, and all but one would have gone home within a few weeks.  Note also that 721 patients are not at high risk, and they will not receive the therapy because the initial diagnosis suggests and events will demonstrate that they will recover on their own.

Now, suppose President Trump launches a crash program on June 16 that by September 15 produces enough of these drugs to provide courses of treatment for one million individuals.  I'm using a million because my next assumption is that the U.S. experience with C19 will echo that of the Spanish Flu.  If that happens, we might well see two million new cases turning up between September 15 and October 15 — or somewhat under double what we have seen reported in the last two months.  If the HCQ+AZT+Zinc therapy is administered to high-risk individuals when they first present with symptoms, and it works according to the results described above, the U.S. will need to supply the therapy to 558,000 patients on first presentation.  It will also face an emergency room load of 12,000 visits, of which about 3,000 are relatively short, and approximately 3,000 will be a few weeks longer.  And we'll have 542,000 surplus treatment packages in reserve to meet demand if the spike is followed by additional cases.

  1. Here's the critical question: if we keep in mind that roughly half of this caseload will likely come from within 100 miles of New York City, can the U.S. medical system and emergency rooms handle such a caseload so that everyone who needs it will get the best possible medical care?
  1. And my final question: If the answer to my previous question is yes, will we even need a vaccine?

I think these are significant questions.  I wish someone would ask them of Dr. Fauci.

Rob Williamson is the pseudonym of a freelance writer with a longstanding interest in political decision making.

A preliminary study done by New York's Grossman School of Medicine reports on the use of HCQ+AZT+Zinc versus HCQ+AZT alone in four New York Hospitals has issued its report. Here's the key finding of the abstract.

Zinc sulfate increased the frequency of patients being discharged home, and decreased the need for ventilation, admission to the ICU, and mortality or transfer to hospice for patients who were never admitted to the ICU.  After adjusting for the time at which zinc sulfate was added to our protocol, an increased frequency of being discharged home (OR 1.53, 95% CI 1.12-2.09) reduction in mortality or transfer to hospice remained significant (OR 0.449, 95% CI 0.271-0.744).  Conclusion: This study provides the first in vivo evidence that zinc sulfate in combination with hydroxychloroquine may play a role in therapeutic management for COVID-19.

The "main finding of this study is that after adjusting for the timing of zinc therapy, we found that the addition of zinc sulfate to hydroxychloroquine and azithromycin was found to associate with a decrease in mortality or transition to hospice among patients who did not require ICU level of care, but this association was not significant in patients who were treated in the ICU."

Here are the statistics:

Discharged home:

  • Zinc, 317 (77.1%) No Zinc 356 (68.3%)
  • Needed ICU Zinc: 38 (9.2%) No Zinc 82 (15.7%)
  • Needed Invasive Ventilation Zinc 33 (8.0%) No Zinc 86 (16.5%)
  • Expired/Hospice Zinc 54 (13.1%) No Zinc 119 (22.8%)
  • Expired/Hospice (Patients needing ICU) Zinc 28 (73.6%) No Zinc 61 (74.4)
  • Expired/Hospice (Non-ICU Patients) Zinc 26 (6.9%), No Zinc 58 (13.2%)

Why do we need a clinical trial of HCQ+AZT+Zinc?

It may cut ICU visits by 40%
It may halve the need for ventilation.
And it may cut the death rate by almost 50%.

Let's try a thought experiment.  Suppose the government launches a full-scale clinical trial of HCQ+AZT+Zinc, perhaps as a control group in the currently ongoing South Dakota or University of Washington clinical trials.  (The latter is already testing HCQ+AZT but not zinc.  To date, outside the Grossman report, I have seen trials testing only one or both of the first two drugs.)  Let's also assume that one or both of these clinical trials do test HCQ+AZT+Zinc on early stage patients and their early results (as of June 15) echo those found in the anecdotal reports of Dr. Armstrong, who saved 39 of 39 patients at a Texas nursing home using this therapy, and Dr. Zelenko, who reported treating 1,450 patients, of whom 405 were high-risk (over 60 with symptoms, under 60 with no symptoms but with an underlying chronic medical problem, as well as anyone who looked sick or had difficulty breathing).  These patients were treated immediately on first presentation with HCQ+AZT+Zinc — without waiting for test results.  "Statistically," Dr. Zelenko says, "out of that number, you would have expected 20 dead, and a multiple of that, perhaps 30 or 40, on a respirator."  But only nine of Dr. Z's patients were admitted to hospital.  Five had pneumonia, and they quickly recovered and returned home.  Four were temporarily on respirators before recovering.  Only two patients died.  None of these patients experienced any side effects during treatment.  The remaining 1,045 patients were low-risk (defined as under 60 with no symptoms and no chronic medical problems such as cancer, diabetes, high blood pressure, things like that), and they were not treated with this therapy and recovered on their own.

If a clinical study of HCQ+AZT+Zinc confirms Dr. Z's results, the president will need to make some decisions fast.  Here's why: 

The history of the Spanish flu epidemic of 1918 suggests that the virus could wane over the summer months and roar back in the fall.  For the sake of simplifying the math, let's assume that Dr. Zelenko treated only 1,000 patients and adjust all his findings proportionately.  In this scenario, he would have had 279 high-risk patients needing the therapy.  Of these, six would have needed to visit the emergency ward for a time, and all but one would have gone home within a few weeks.  Note also that 721 patients are not at high risk, and they will not receive the therapy because the initial diagnosis suggests and events will demonstrate that they will recover on their own.

Now, suppose President Trump launches a crash program on June 16 that by September 15 produces enough of these drugs to provide courses of treatment for one million individuals.  I'm using a million because my next assumption is that the U.S. experience with C19 will echo that of the Spanish Flu.  If that happens, we might well see two million new cases turning up between September 15 and October 15 — or somewhat under double what we have seen reported in the last two months.  If the HCQ+AZT+Zinc therapy is administered to high-risk individuals when they first present with symptoms, and it works according to the results described above, the U.S. will need to supply the therapy to 558,000 patients on first presentation.  It will also face an emergency room load of 12,000 visits, of which about 3,000 are relatively short, and approximately 3,000 will be a few weeks longer.  And we'll have 542,000 surplus treatment packages in reserve to meet demand if the spike is followed by additional cases.

  1. Here's the critical question: if we keep in mind that roughly half of this caseload will likely come from within 100 miles of New York City, can the U.S. medical system and emergency rooms handle such a caseload so that everyone who needs it will get the best possible medical care?
  1. And my final question: If the answer to my previous question is yes, will we even need a vaccine?

I think these are significant questions.  I wish someone would ask them of Dr. Fauci.

Rob Williamson is the pseudonym of a freelance writer with a longstanding interest in political decision making.