Serology Study Suggests Infections Greatly Exceed Confirmed Cases

A new serology (antibody) study conducted in Santa Clara County suggests that COVID infections are 25 to 50 times higher than the number of confirmed cases.  During the study period, SC county had 1870 cases and 73 deaths reported among its 1.7 million residents. The serology study estimated that 2.5% – 4.2% of county residents have been infected – which converts to between 48,000 – 81,000 total infections…  exceeding the number of known cases by a factor of 25–50.

If confirmed, this would suggest the overall infection fatality ratio would be approximately 0.1 – 0.2%, much lower than the current overall estimate.

Note:

The University of Arizona will begin providing antibody tests for 250,000 health care professionals and first responders who are on the front lines in the battle against COVID-19.  The UA will administer the antibody tests to check for antibodies through an individual’s blood sample to determine if they were exposed to COVID-19, had the virus and recovered.

I didn’t see when this actual work will begin, but that’s probably because there will be some type of approval that needs to happen first. These results will be the first good look we have into where we really are when it comes to herd immunity here in AZ.

Maricopa Association of Governments Produces Health Assets Viewer

The Maricopa Association of Governments Regional Analytics team has developed a statewide health assets viewer to assist with coordinating the COVID-19 response.  The new tool features population concentrations; a vulnerability index based on demographics such as age, income and access to medical care and technology; congressional and legislative districts; medical care locations with contact information and bed capacity; and weekly charts with the number of cases per county.  Users can sort the information by county, jurisdiction, or zip code.

Remdesivir Study Shows Lower Mortality Rate in Severe COVID-19

Remdesivir is emerging as an early leader in the quest for antiviral medications against SARS-CoV-2, the virus causing COVID-19. Overall mortality in treated patients was 13%, lower than in previously published studies of non-treated COVID-19 patients with serious symptoms.

Results from a clinical study showed that clinical improvement was observed in 68% of patients (36 of 53). The trial’s findings, funded by the drug’s manufacturer Gilead Sciences, were published in the New England Journal of Medicine.

Evidence Mounts that Existing AZ Hospital Capacity is Adequate with a Wide Margin of Safety

Evidence continues to mount that the public’s social distancing measures are slowing the spread of new COVID-19 infections in AZ, and that existing hospital capacity is adequate with a wide margin of safety.

The newest run of the IHME model predicts that Arizona has already reached our peak hospital demand (with the in the last few days). Future demand is predicted decline slowly over the next 4 weeks. The model no longer shows any scenarios in which capacity is likely to be exceeded (in the short-term).  Importantly, this model outcome assumes that we continue to maintain our social distancing efforts over the coming weeks.

Our statewide mitigation success provides policy makers with an opportunity to revise some earlier policy decisions that will improve public health while continuing to ensure that Arizona has the hospital surge capacity to meet peak demand for patients with COVID-19. 

Elective Procedures

The resulting safety margin for hospital capacity and our hospital system’s improving planning regarding the use of personal protective equipment provides an opportunity to relax the limitations on elective procedures under Executive Order 2020-10. We believe that adjusting Executive Order 2020-10 to allow hospitals to conduct elective procedures would improve public health outcomes for patients and allow for continued adequate surge hospital capacity.

Hospital Capacity

Under Executive Order 2020-16, Arizona hospitals have already implemented plans to increase hospital capacity by 25%. The Order further directs that hospitals implement an additional 25% increase by April 26. Given the success of Arizona’s control measures, and the predictive models suggesting that Arizona already has adequate capacity to meet peak demand, we urge the suspension of E.O. 2020-16 (the directive that Arizona hospitals increase capacity by another 25% by April 26).

Alternate Care Sites

The State has been preparing to stand up alternate care sites to handle the surge that was expected using model runs from a month ago (e.g. opening the closed St Luke’s Hospital).  Data and predictive modeling is now making it clear that scaled alternate care sites won’t be needed- and those financial resources and staff effort would be better served by improving testing and contact tracing capacity in my opinion.

Follow-up Hydroxychloroquine Studies Disappointing

While Hydroxychloroquine showed some early indications that it may be helpful as a therapy to treat COVID-19 – recent trial results suggest that it’s probably a dead end.A French study this weekshowed that the drug is not clinically efficient for use of patients with COVID-19. The study retroactively looked at the medical records of 181 patients diagnosed with COVID-19 and whom developed pneumonia and required oxygen.

Forty-eight hours after being admitted, 84 patients were given Hydroxychloroquine and doctors found that there was no statistically significant difference in death rates. A side effect of taking of the drug is abnormal heart rhythms.

While a small study, it shows that this drug may not be suitable to use on COVID-19 patients. Additional studies are needed with larger sample sizes. This study has not been peer-reviewed and does not state how long patients remained in the hospital or have symptoms after taking the drug.

 

The Number of Diagnostic Kits is Expanding

The FDA has a very streamlined process for authorizing the emergency use of a host of testing kits for the novel coronavirus (2019-nCoV).  Some are the classic PCR tests and some are antibody tests (IgM and IgG).

So far there are 30 different tests on the Emergency Use Authorization list.  Here is a link to the FDA’s  Test Kit Manufacturers Table which includes the manufacturer and their contact information, fact sheets for providers and patients and instructions.

COVID-19 Vaccine Update

Various health and research agencies in the United States have begun work to create and develop a safe vaccine to combat COVID-19. Since the beginning of this year there has been a growing number of clinical trials for COVID-19 because of its increase incidence rate and mortality.

The first-in-human vaccine trial was administered in early March by the National Institute of Allergy and Infectious Diseases (NIAID) in Seattle, Washington. This vaccine trial is being conducted with 45 healthy males and non-pregnant women, ages 18-55 over approximately six weeks. The vaccine trial is expected to end in June 2021.

Additionally, the U.S. Department of Human and Health Services is working with New Jersey-based Janssen Research and Development, part of Johnson & Johnson, and Moderna of Cambridge, MA. The Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response, will support Phase 1 clinical trial of Janssen’s COVID-19 investigational vaccine.

This clinical trial will evaluate the vaccine’s safety in healthy adult volunteers and its ability to induce an immune response. This trial is expected to begin in Fall 2020, with the goal of making COVID-19 vaccinations available for emergency use in the U.S. in early 2021.

For more information about the COVID-19 vaccine clinical trials visit this site.

Natural Experiments Underway Across the Globe

Natural experiments are happening real-time during this pandemics and different countries take various public health intervention approaches to the COVID-19 pandemic. 

For example, Sweden is implementing calibrated precautions and isolating only the most vulnerable rather than imposing a full lock-down.  Gatherings of more than 50 people are prohibited but they have kept their borders open as well as its preschools, grade schools, bars, restaurants, parks, and shops. 

The strategy is to focus on social distancing among the known risk groups, like the elderly… and to develop herd immunity as their young people spread the virus (mostly asymptomatically) generating protective antibodies that make it harder for the virus to find a new host.  In the meantime, the social distancing measures focus primarily on the elderly and folks with chronic medical conditions.

The controls (Norway and Switzerland) are implementing measures much like the ones underway here in the U.S., with aggressive social distancing of the entire population (of course each state has a different idea about what the definition of an essential service or industry is). 

University researchers will be able to compare the effectiveness of the various public health intervention strategies and determine which were effective and how. The research will be able to shed light on the intervention effectiveness with respect to hospital capacity and mortality from the virus, but also compare the short and mid-term impact to the economy, GDP and the effects that those economic changes influence the social determinants and outcomes.

At the end of this pandemic we should have a rich base of public health literature to draw upon for future pandemics. Up until now, we’ve had to rely on old literature from 1918 and experiences from the less impactful H1N1 pandemic.

Evidence Mounts that Existing AZ Hospital Capacity is Adequate for the Surge

Social Distancing Successes Provide Policy Opportunities

Evidence continues to mount that the public’s social distancing measures are slowing the spread of new COVID-19 infections in AZ. The IHME model as run by Joe K. Gerald, MD, PhD now predicts hospitalizations will peak on April 26th. The mid-range estimate calls for 1,460 beds at the peak, suggesting that bed capacity (including ICU beds) will be fine – with a safety margin (even without the 50% bed capacity increase directed by Executive Order). For perspective, we currently have 6,017 regular beds available- a wide safety margin indeed.

On the intensive care front, the Model now predicts ICU usage will peak on April 27th. The mid-range estimate calls for 293 beds at the peak, below the 508 available (a nice safety margin). Again, suggesting that ICU bed capacity will be fine even without the mandated 50% ICU bed capacity increase.

These models assume that we continue to maintain our social distancing efforts over the coming weeks. According to Dr Gerald’s analysis, the lag between new infections and hospitalizations and ICU admissions means that the pace of these outcomes will increase for the next 1-3 weeks before slowing.

Over the next 2 weeks, hospitals should prepare for a continued increase in admissions until a peak around April 27th. The strain is likely to be greater in critical care settings than general floor beds, but there appears to be adequate capacity to meet demand.

Our mitigation successes provide policy makers with an opportunity to revise some earlier policy decisions that will improve public health while continuing to ensure that Arizona has the hospital surge capacity to meet peak demand for patients with COVID-19. 

Hospital Capacity

Under Executive Order 2020-16, Arizona hospitals have already implemented plans to increase hospital capacity by 25%. The Order further directs that hospitals implement an additional 25% increase by April 26. Given the success of Arizona’s control measures (and the predictive models suggesting that Arizona already has adequate capacity to meet peak demand with a wide safety margin) we urge the governor to suspend the directive that Arizona hospitals increase capacity by another 25% by April 26.

Elective Procedures

The resulting safety margin for hospital capacity and our hospital system’s improving planning regarding the use of personal protective equipment also provides an opportunity to relax the limitations on elective procedures under Executive Order 2020-10. Specifically, we believe that adjusting Executive Order 2020-10 to allow hospitals more discretion regarding elective procedures would benefit public health by allowing Arizonans access to procedures while ensuring hospital capacity.

Note: Here is Maricopa County Department of Public Health’s hospital admissions epi-curve data… updated 4/14/20.

All of Us Research Program Could End Up Being a Great Tool for Tracking Herd Immunity to COVID-19

The All of Us Research Program is a historic effort to collect and study data from one million or more people living in the United States. The program began national enrollment in 2018 and is expected to last at least 10 years. The core objective of the program is to build the evidence base to facilitate healthcare’s increasing use of precision medicine. But it might also end up serving as an opportunity to track the path of herd immunity to the Coronavirus over time. More about that later- but first lets explore what All of Us is all about.

Too often, health care is one size fits all. Treatments meant for the “average” patient may not work well for individual people. Health care providers may find it difficult to coordinate care among specialists or to access all of a patient’s health information. Researchers may spend lots of time and resources creating new databases for every study.

All of Us is working to improve health care through research. Unlike research studies that focus on one disease or group of people, All of Us is building a diverse database that can inform thousands of studies on a variety of health conditions. This creates more opportunities to:

  • Know the risk factors for certain diseases

  • Figure out which treatments work best for people of different backgrounds

  • Connect people with the right clinical studies for their needs

  • Learn how technologies can help us take steps to be healthier

All of Us is creating a database on the All of Us Research Program website. Everyone can use this database to make discoveries. There are different levels of access. Some information is visible to the public. Some information can only be seen by approved researchers. The information in the database that anyone can see will be about the group of participants. For example, it might tell the average age of the people who have joined the All of Us Research Program. It will not include information about individual people.

Only researchers approved by the All of Us Research Program will be allowed to see data from individual participants. The data will not include your name or other information that directly identifies you. These researchers may be from anywhere in the world. They may work for commercial companies, like drug companies. The research may be on many different topics.

Will one be about COVID-19?

The program started collecting bio samples in 2018. I was one of the first participants in the program, and I provided samples for the program a couple of years ago. That means that the bio samples are being collected before, during and after the COVID-19 pandemic.

That means researchers might be able to use blood samples from before, during and after the pandemic to track the progression of the disease (and the pathway toward herd immunity) by looking at IgG antibodies over time- producing an epidemiological record how, where, among whom the virus spread.

You can participate in All of Us too. It’s simple and easy. You can sign up directly through JoinAllofUs.org or at a participating health care provider organization

Check it out!