COVID-19 Update 8/5: Latest Data, Antibody Tests and Treatments, and Metabolic Health

Dr. Steven Bishop returned to Facebook Live on August 5 for another COVID-19 update. He discussed the latest data trends, new antibody treatments under development, the importance of metabolic health, and answered questions on rapid testing, viral symptoms, and more. Watch the video below and read on for the full recap. 

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Numbers in Virginia and the U.S.

We had an increase in cases in Virginia over the course of July, mostly due to the eastern portion of the state. The numbers have once again stabilized and begun to trend down, which is great news. Deaths are very low across the state. There was one death recorded Tuesday in Northern Virginia. In Central Virginia, there hasn't been a reported death since July 29. Fantastic news. Numbers in Virginia aren't too bad overall. 

If you zoom out to the whole country, Texas, Florida, and California are driving a lot of the new cases. According to the CDC, case numbers overall appear to be stable from last week to this week. There has been a slight decline in hospitalizations and deaths in general across the country have gone slightly down. So, a lot of good news. Still not totally under control but it's better than the last few weeks.  

New Antibody Treatment from Eli Lilly

This is a new antibody treatment from Eli Lilly that just started recruiting patients for a clinical trial. They are recruiting actively sick people and will give them an infusion of monoclonal neutralizing antibodies. These antibodies bind up the virus and keep it from spreading in the body. This is a different one from the COVID shield we've discussed before from Sorrento, but it's a similar concept. You give someone antibodies right before or right as they get sick. I hope the strategy will show promise. It makes a lot of clinical and medical sense.

I think it may be more successful than what they've done with the convalescent antibodies, where they have taken plasma from people who have recovered and given it to sick people. That hasn't panned out very well in the trials, but that may be because it's not concentrated versions of specifically neutralizing antibodies.

Whenever you hear something about antibodies, you want to hear the term neutralizing. These drugs that are being created are highly concentrated versions of neutralizing antibodies, so I'm hoping that these will prove effective. 

Two New Antibody Tests Approved

The FDA recently approved two new antibody tests, which will be helpful for medical providers and researchers. The current antibody tests are what they called qualitative. It tells you if antibodies are there are not. It doesn't tell you how much is there or, if it's below a certain threshold, it doesn't detect it at all. There's a possibility with these that you could have a very low level of antibodies but the test just can't detect them. 

These new antibody tests are from Siemens and will tell us the amount of antibodies. It won't give a specific number, but it will say low, medium, or high. It's going to be a better overall test to tell us not only whether you have antibodies, but also how much.

That will be helpful in telling us whether these antibodies are going to stick around and what kinds of people develop really robust antibody responses to the infection, because not everyone does. Lots of reports have come out where people have antibodies for awhile and then they disappear. It seems to be the people who don't get very ill, the one's that have mild illness. The ones who get sicker seem to have antibodies that stick around longer.

We'll get a lot better information from these types of tests, where we are able to quantify a little bit better how many antibodies are being produced. 

Vaccine Research and Metabolic Health

A lot of researchers and public health officials are concerned about the efficacy of the vaccines, not just because of the technology and whether we will be able to accomplish it or not, but because of our population. Vaccines in general are not as effective when people have metabolic disease, or are overweight, or have obesity.

Unfortunately, a huge proportion of our population has problems with weight and obesity and metabolic disease, meaning pre-diabetes, diabetes, high blood pressure, etc., so the worry is that even if we get a vaccine, it won't be as effective as it could be because of those issues.

This is my plea, a public service announcement, if you have any of those problems, reach out to your doctor now. Start working on it. Get your diabetes under control. Improve your diet. Start exercising. Talk to your physician about what you need to do to lose weight, because that's going to be critical.

Even if we do get a vaccine, improving your metabolic health is the most important thing you can do to stave off the illness, and if you do get sick, to hopefully make your illness as mild as possible, AND, to make you as best a candidate for a vaccine as possible, because people who are metabolically healthy respond better to vaccines in general. That's true with all vaccines. 

If you're a PartnerMD member, we have lots of tools to help you out with that. Just talk to your doctor about what we can do. If you're not a PartnerMD member, please talk to your physician about metabolic health. 

Your Questions, Answered. 

• My daughter had a blood test for COVID-19 and for antibodies in a pharmacy in Paris with immediate results - have you heard of this type of test?
  
  Yes, absolutely. These are tests we are trying to get in various places throughout the country. We do have them here at PartnerMD, but they are difficult to obtain because of something called a CLIA-waiver status. We talked about this some last week. Not all physicians offices have access to these tests yet.
  
  There are "immediate" results tests for COVID antigens and COVID PCRs. They aren't quite immediate; it's usually 20-60 minutes. Those tests are widely available at places like BetterMed and we are working to get those as well.
  
  We have been using, since early April, COVID point of care antibody tests, because we have a moderate complexity CLIA-status for our lab (in Richmond). Those tests provide us data within 10 minutes if someone has antibodies or not, but those are not widely available because of the CLIA issue. You have to have a moderate or high complexity lab in order to use those tests, so most doctors offices cannot use them in the United States as of yet.
  
  I am hoping the FDA will grant them a CLIA-waived status, which will make them equivalent to something done commonly throughout doctors offices, such as a pregnancy test. Once that is accomplished, then I think you will see the rapid emergence of those tests pretty much everywhere. They are very inexpensive compared to the other test types.
    
• Avoiding the politics surrounding the voting issue right now, do you think that voting in person, using all precautions, is safe?
  
  I think so. It's fairly simple to social distance people, you kind of have to be distanced anyway for voting. I think if people wear mask, if they set the lines 6-feet apart, they give each person their own pencil, wipe down the voting booths, etc., I think that's pretty simple to do. Where we vote we feed our ballot into the machine ourselves so no one else touches it.
  
  If you're a place with electronic voting, same thing, wipe down the screens after each user. I don't think that's too difficult. They will probably have to have more polling station volunteers to try and make things stay as clean as possible. There are some things they will have to do to make it safer, but I think it can be done. 
• Are any monoclonal antibody therapies in phase 3 clinical trials? If so, how many? Also, how long do clinical trials for antibody therapies take versus vaccine trials?
  
  The only ones I'm aware of, from Sorrento and Eli Lilly, are in Phase II. These are smaller trials they are doing mostly for safety and some efficacy data before moving onto Phase III.
  
  Clinical trials for antibodies are usually pretty fast, because it's a treatment trial. Treatment trials are much simpler to do. They just have to recruit sick people, give them whatever the drug is, and see if they get better, which happens usually pretty quickly. 
  
  So if the researchers are efficient about the data collection and data analysis and publication piece, you can probably see something published within weeks to a month after the trial is completed. If they're starting trials now in early August, I would expect to see something late September in terms of the data on Phase II antibody trials. Phase III, if the therapy works and is safe, they can probably start Phase III pretty quickly after that.
  
  But it's definitely much faster than vaccine trials, because especially the safety piece. Monoclonal antibodies don't stick around in the system very long, so you generally know whether they are going to cause harm much quicker than a vaccine.  
   
• What are your top three therapies at this moment? By contrast, what do you hope will be your top three therapeutics by, say, the end of October?
  
  My top therapies will differ based on if it's for a hospitalized patient vs. a non-hospitalized patient. For a hospital patient, there's not really a top three. It's really two. Remdesivir, the anti-viral drug, and IV Dexamethasone seem to be the only ones with reasonable data for people who have severe disease and they need oxygen supplementation. 
  
  For a non-hospital patient, the caveats being the data is not complete and going past all the politics of outpatient treatment of COVID-19, I'm not sure I have a top therapy. There is nothing approved and nothing with extremely robust data. But the hydroxychloroquine, zinc, azithromycin cocktail is certainly one that is reasonable to use and inhaled budesonide is another one that is a reasonable therapy to use.
  
  Other than that, it's general good viral care. Hydration, rest, anti-inflammatory drugs like Advil or Aleve.
  
  In October, if I had my dreams, I would hope something like the COVID shield would be effective and easy to use, and we could use as a prophylactic. Or that our officials do what we need to them and do the trials on some of these other outpatient treatments, like hydroxychloroquine and others, and truly figure out in a large-scale outpatient trial if these things work or not. If someone can do a big trial and show that one of these drugs is great for prophylaxis, fantastic, then we just give it to people assuming that it is safe.
  
  That would be my dream, to have an easy prophylactic drug that's either a pill or something else if it comes along. Or we have something we can give people on a periodic basis, that would be my second option, something like the COVID shield where we could give people once a month, an antibody injection, they could take it at home once a month to prevent them from getting sick while we continue to work on a vaccine. 
  
  I put the vaccine third, not because of its importance, but because of the likelihood it is going to be available. I don't think it will be available by October or even the end of the year. I'm hoping the trial results will be settled on a vaccine by the end of the year, but it's not going to be ready by then. 
  
  
• My son is going back to college in Indiana. What are some of the things he should think of to keep himself safe? 
  
  For the most part, as a young college-aged person, assuming he's otherwise healthy, he just needs to follow the guidelines. Wash your hands, don't touch your face, stay away from sick people, avoid large crowds. Don't go to parties with hundreds of people. Quarantine himself and get tested if he becomes sick. And wear a mask if you're going around other people if you have no medical reason not to wear one. 
  
  
• What do we think flu season combined with COVID-19 will be like?
  
  Really interesting question. What we're all concerned about is that the two things will combine and it will be a huge disaster. That being said, it seems like a lot of what we are doing to prevent COVID is also working for flu. It's a good public health practice for respiratory viruses of all kinds.
  
  We were looking at a report from the Wall Street Journal last week about the Southern Hemisphere, where it is flu season right now. They actually are seeing very little flu compared to prior years, and it's probably because of all the distancing, the mask wearing, the hand washing, all that stuff that we are keenly paying attention to...it works for flu, too. 
  
  I'm hoping that we see the same thing here, as long as people continue doing what they are doing for COVID, and we may avoid the situation we're all afraid of, which is flu season combining with COVID. 
  
  
• Particularly with respect to children, one of the issues being discussed a lot recently is the long term effects, like heart inflammation, that the virus might cause. Regarding such inflammation, do other viruses also sometimes cause such inflammation, and if so, how long does such inflammation last?
  
  Yes, this is extremely common. Many viruses can cause auto-immune disorders or inflammatory-type disorders. We actually got an email on Tuesday from the Virginia Department of Health warning us about acute flaccid myelitis season.
  
  Over the last few years we've been battling the resurgence of an odd polio-like infection in various parts of the country where children are coming down with these paralytic illnesses similar to polio. It's not polio. They think it might be enterovirus, which is a gut virus and can cause inflammatory syndromes. 
  
  Viruses cause all sorts of strange things beyond their immediate effects. They cause inflammation. They cause post-viral syndromes of all kinds. Post-viral irritable bowel syndrome is a common one. It doesn't surprise me that COVID is doing this with children, and adults, too. Some of these things may be permanent, some may be temporary in terms of how long the inflammation might last.