This the Beginning of the End. From what I have learnt this week, I think that Known Risk Factors, Treatment, and Testing knowledge mean that the pandemic will soon begin to recede. What do we know now that we didn’t know last week?
Risk factors:
My own data and new data coming in from other doctors makes it clear: Diabetes (DM), pre-Diabetes (preDM), and Obesity are risk factors for severe COVID infection.The data are remarkable as the association of DM with a viral infection is unprecedented. It goes against my education, training and experience. But it is very real.
Notably by today, I have 20 patients intubated (tube down throat and on a vent). 18 out of the 20 had DM (diabetes). Th remaining 2, you ask? PreDM. Obesity is associated with insulin resistance and often eventually leads to Type 2 DM. So, it appears there some relation poor glucose control and severe COVID disease. By identifying people at risk of severe disease, we can now design approaches to keep protect them more than others from this infection.
Treatment:
The Marseilles group, led by Dr. Didier Raoult, have released two papers on using HCQ given with a Z-pak. The first paper, released on March 17th, demonstrated that people on HCQ cleared virus better than controls and that patients on HCQ/Z-pak cleared virus better than HCQ did by itself.
Last Friday, Dr. Raoult’s group released clinical data. 80 COVID pateints were treated with the HCQ/Z-pak combination. They did not have a control group. By Day 5, 97.5% of the patients had negative virus cultures. By Day 8, 93% were also RT-PCR negative. Many people think virus culture is more meaningful than RT-PCR, but that’s not proven yet.
When Dr. Raoult reported, 78 of the 80 patients recovered, 1 died and 1 was in the ICU still. Critics noted that the study had no control group; and, therefore, one could not conclude how effective this combo was compared with placebo. That’s true.
BUT there are many treatments which we use every day and consider first-line that similarly used historical controls. For Infectious Disease buffs, tetanus vaccine is an example. It was never studied in a controlled study. In past 15 years, Zosyn has been used in “extended infusion” or EI, which means Zosyn is infused IV over 4 hrs only 3 times per day. Usually, Zosyn is infused 4 times per day over 30 minutes.
Twice, EI of Zosyn has been studied using historical controls. EVERY hospital in the country uses EI, because is saves money, 3 doses per day instead of the usual 4 dose. “OUR” journal, called Clinical Infectious Diseases published both of these studies and praised them, even though they used historical controls for many years before. To this very day, EI Zosyn is given in every US hospital every day and we still do not know how well it works or doesn’t compared the standard dosing.
In this case, the Marseilles group’s data were so much more impressive than anything we have seen before. Just as important, the Marseilles group reported that the combination was safe.
My team started using HCQ/azithro after the first paper was released. Concerned about toxicity, we carefully monitored patients. Dr. Dave Dobesh volunteered (after I guilted him for being home doing nothing) to interpret their EKGs, which we performed very often. Dave is an outstanding EP cardiologist. So far, has gone through every EKG of over 40 patients. Dave found that this HCQ/azithro rarely causes EKG changes and only does so when the patients is on another drug, which affects the heart.
My team, of course, followed outcomes. Last week, Julie Traupman (nee Egan) mentioned how some docs were reporting late deteriorations of patients. That made me think about our intubated patients. Were we seeing late deteriorations. If the HCQ/azithro weren’t working, then we should intubations all throughout the hospital stay. So, my team quickly gathered the data. I was stunned. Almost all (16 of 20 patients) had been intubated in the first 1.5 days. Accordingly, none has been intubated after receiving 5 or more days of HCQ/azithro. These data, to me, prove that HCQ/azithro is working and clearing the infection. I am pretty sure it’s not the hospital food causing this effect.
Yesterday, as noted in the NYT, Chinese researchers published results from an HCQ clinical trial. The group randomly divided COVID patients to get placebo or HCQ alone. The dose of HCQ was 60% lower than the Marseilles’ group, but the patients had very mild disease. In fact, NONE of our patients would qualify for this study, because they are too sick. Still, HCQ outperformed placebo. 4 control patients progressed to serious illness; none of the HCQ patients did. Similarly, patients on HCQ cleared pneumonia more quickly than control patients. This study proves the HCQ works against COVID.
To me, the Chinese researchers made two observations which are maybe even more important. The Chinese group said two simple things about COVID and HCQ, which is used as chronic treatment for Lupus:
1. 80 Lupus patients are chronically taking HCQ; none has gotten COVID.
2. Conversely, 178 patients admitted to the hospital had COVID; none was on HCQ prior to admission.
From this Chinese study, now we KNOW HCQ works against COVID. From the Marseilles group’s data and our data, We KNOW the combination of HCQ/azithro works against COVID. From the Lupus patients, we think chronic HCQ use protects against COVID. Lupus patients take the same dose as the used in the Chinese study, but they take it for life, not just 5 days.
Antibody Testing:
Tests which can specifically detect COVID antibodies are being rapidly developed. The vast majority of patients recover from COVID and they develop antibodies this virus. If these tests are accurate, then we can identify people are now immune to COVID. The post-COVID patients can go around and socialize with anyone. Most probably, they can’t get re-infected, they can’t get sick or give the virus to anyone else.
Why the Beginning of the End?
So, now, with a valid treatment and antibody testing we can figure out who is COVID immune so they can go back to work/life andwe can prevent new infections and deaths.
The percent of people, who have immunity against COVID is unknown. Since asymptomatic infection is common and since most COVID patients recover, there should be hundreds of thousands of Americans who are COVID immune and they can go back to life as known before March 2020.
We know that HCQ works effectively treats COVID and we pretty dang sure HCQ protects people against COVID. We also know who is at high risk for severe disease - DM, preDM and obese individuals. As above, we can reduce the chances of DMs, etc. from contracting COVID by not allowing them to be exposed to COVID patients. But also, as soon as the Pharmas pick up production, we can use HCQ to prevent infection of those at increased risk of serious infection AND those who have a greater chance of infection, i.e. nurses, doctors, techs, police women and men, and other first responders, on HCQ prophylaxis. I happen to know that a Brooklyn FDNY Ladder 149, led by Captain Ciro Napolitano, is mostly immune already. But if not immune, first responders and HCWs can go on HCQ indefinitely. HCQ is already FDA-approved for malaria prophylaxis (only use it certain countries). Why not use HCQ for COVID prophylaxis?
So as proper dosing and testing is rolled out throughout the West, I believe the beginning of the end of the pandemic is upon us.
About Safety Concerns:
In closing, for those who think HCQ is highly toxic, I refer you to the literature on Lupus therapy. Lupus patients take HCQ every day for years, at the same dose used in the Chinese study above. HCQ builds up over months, so the blood levels in Lupus patients are much, much higher than the HCQ levels were in patients in the Chinese study, who took HCQ for 5 days.
“Hydroxychloroquine is the cornerstone of medical therapy in lupus. It should be used in every patient unless there is a clear contraindication. It is the only medication shown to increase survival in lupus patients.”
Fava A, Petri M. Systemic lupus erythematosus: Diagnosis and clinical management. J Autoimmun. 2019 Jan;96:1-13. doi: 10.1016/j.jaut.2018.11.001. Epub 2018 Nov 16. PMID: 30448290; PMCID: PMC6310637.
Here’s to seeing you at a “social gathering”, sharing a beer, kissing each other on the cheek, and double-dipping soon...ok, don't double-dip, that's gross.
Sincerely,
Dr. Stephen M. Smith
Dr. Steve take one dip and end it! Thank you.