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.
The Association of State and Territorial Health Officials collaborated with Johns Hopkins University to produce A National Plan to Enable Comprehensive COVID-19 Case Finding and Contact Tracing in the US. The report calls for a robust and comprehensive system to identify all COVID-19 cases and trace all close contacts of each identified case, and outlines a vision—complete with resources and specific action steps—to accomplish this goal. Here’s the media release.
Also, the Singapore Ministry of Health has built a Contact Tracing App that conducts scaled contract tracing and involves public engagement in the process. They recently announced they’re making it open source. The advantage of something like this is its value in identifying pre-symptomatic contacts, while maintaining confidentiality.
I downloaded the App to test it out but couldn’t activate it because on the verification screen they have Singapore’s country code hard wired.
The federal government issued new guidelines to help state and local government officials with decision criteria to consider to relax some of the interventions currently in place without jeopardizing public health from exceeding hospital treatment capacity.
It’s a three-phase set of guidelines for governors and others to consider with the goal of mitigating the risk of resurgence and protect the most vulnerable. The guidelines specify symptoms, cases, and hospital capacity criteria that must be satisfied before proceeding to a phased comeback.
Take a look at the guidelines for yourself. My take was that it is reasonably well thought out but there wasn’t any gating criteria emphasis (page 1) regarding diagnostic and antibody testing availability.
That seems like a pretty big oversight to me- as testing availability is important for contact tracing (once community spread wanes). Widespread accurate antibody testing is also important information for businesses to have access to as they plan their individual re-openings.
The guidelines don’t even mention predictive modeling as a gating criteria component. Predictive modeling can provide important information for decision makers- arguably more important than the information provided by looking at simple trends in case counts (gating criteria number 2).
There’s also a big emphasis on syndromic survieillance in the gating criteria that (in my opinion) is given too high of a priority. I would have replaced the syndromic surveillance gating criteria with predictive modeling outcomes.
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.
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 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 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.
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 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.
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.
