COVID-19 Update: March 24th - April 5th
Welcome to the McGraw-Hill COVID-19 channel. This week we have information on a new FDA page that tracks mutations and how the mutations effect testing results, information on increased mortality with the British Variant B.1.1.7, information on enhanced communication with patients using an adaptive mask with a clear window, and demographic information about mental health problems related to COVID-19. Finally, bamlanivimab use as a single agent has been halted in the United States.
The FDA is maintaining a website that tracks SARS-CoV-2 variants and the impact these variants have on the validity of testing. There are now multiple variants of the SARS-CoV-2 virus in circulation. The FDA notes that depending on the variant and the test, there may be more false-negative tests. They recommend using a test that has multiple genetic targets to reduce the impact of genetic variations on the validity of tests. Test results should always be interpreted in conjunction with the clinical presentation. If the patient is symptomatic and a false negative test is suspected, repeat testing with a different diagnostic test should be considered. The tests that have been impacted by viral mutations as of 3/30/2021 include:
- Accula SARS-CoV-2 Test (Mesa Biotech Inc.)
- Linea COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
- TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, Xpert Omni SARS-CoV-2 (Cepheid)
This makes it more important to know what variants of SARS-CoV-2 are endemic locally and what test your laboratory is using. Complete information can be found here.
- US FDA. SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests
Patient communication is enhanced when providers use a clear mask. Communication is critical in medicine, especially now. This is a study of communication between surgeons and patients using a traditional mask or a clear mask. Two-hundred patient visits were randomized to visits in which one of 15 surgeons used either a standard surgical mask or a clear mask (equivalent to a surgical mask in efficacy (ASTM level 3)). High risk contacts in whom an N-95 mask was required were excluded from the trial. Several domains were examined including explaining, listening, answering questions, empathy, patient trust in surgeon decisions and comfort with the operative surgeon. More patients rated the surgeon higher in empathy (99% vs. 85%), had trust in the surgeon’s decision making (94% vs 72%), and believed the surgeon explained things clearly (95% vs. 78%) (p<0.001 for all) when the surgeon wore a clear mask. Overall, patients preferred the clear mask. The surgeons weren’t as pleased and worried about the safety of the clear masks with only 47% being positive about the experience on a 4-point Likert scale.
This is a small study; however, at least some communication is enhanced by the use of clear masks. Given the difficulty of patient communication in the best of times, anything that helps is welcome. The full study can be found here.
- Kratzke IM, Rosenbaum ME, Cox C, Ollila DW, Kapadia MR. Effect of Clear vs Standard Covered Masks on Communication With Patients During Surgical Clinic Encounters: A Randomized Clinical Trial. JAMA Surg.Published online March 11, 2021. doi:10.1001/jamasurg.2021.0836
Mortality is increased in those infected with the British SARS-Co-V2 variant B.1.1.7 when compared to the wild type. Two recent articles examine the mortality from the B.1.1.7 SARS-CoV-2 variant when compared to the wild type.
The first study from the BMJ is a community based matched cohort study of 109,812 individuals, half with the B.1.1.7 variant and half with wild type virus based on a positive PCR and viral genetic testing. The outcome was mortality, either in the hospital or in the community. The hazard ratio for death with the British variant when compared to the wild-type virus was 1.64 (95% CI 1.32-2.04, p <0.001). The overall absolute risk ranged from 2.4-4.1 deaths per 1000 cases.
The second study from Nature looked at 1,146,534 PCR positive SARS-CoV-2 individuals in whom the genetic subtype of the SARS-CoV-2 was identified. Of these, there were 4,945 deaths. The death rate was adjusted for age, sex, care home residence, etc. The absolute mortality varied depending on patient age, but was higher in those with the B22.214.171.124 variant (overall hazard of death 61%(42%-82%) higher). The absolute risk increased by age but was <1% in those less than age 70.
The B.1.1.7 virus variant seems both more contagious and more deadly. Both Moderna and Pfizer/BioNTech have released statements that their respective vaccines are effective against the B.1.1.7 strain which is somewhat reassuring.
- Challen R, Brooks-Pollock E, Read J M, Dyson L, Tsaneva-Atanasova K, Danon L et al. Risk of mortality in patients infected with SARS-CoV-2 variant of concern 202012/1: matched cohort study BMJ 2021; 372 :n579 doi:10.1136/bmj.n579
- Davies, N.G., Jarvis, C.I., CMMID COVID-19 Working Group. et al. Increased mortality in community-tested cases of SARS-CoV-2 lineage B.1.1.7. Nature (2021). https://doi.org/10.1038/s41586-021-03426-1
The CDC has released more data on the mental health effects of the SARS-CoV-2 pandemic. This is a study conducted between August 2020 and February 2021 looking at the social and economic impacts of the COVID-19 pandemic. Phase 3 of the study, from August 2020 to February 2021 included 358,977 individuals. The findings include an anxiety or depressive disorder in 41.5% of respondents, up from 36% in the prior period (August 2020-December 2020). This increase was especially acute in those 18-29 years of age and those with less than a high school education. Unmet mental health needs were reported by 11.7%.
This study emphasizes that the pandemic continues to take its toll on the mental health of Americans. We should remain vigilant for mental health concerns among our patients. The full study can be found here.
- Vahratian A, Blumberg SJ, Terlizzi EP, Schiller JS. Symptoms of Anxiety or Depressive Disorder and Use of Mental Health Care Among Adults During the COVID-19 Pandemic — United States, August 2020–February 2021. MMWR Morb Mortal Wkly Rep 2021;70:490–494. DOI: http://dx.doi.org/10.15585/mmwr.mm7013e2external icon.
Briefly, the FDA withdrew bamlanivimab as a single agent from distribution on March 24th, 2021 because of a lack of efficacy against emerging SARS-CoV-2 strains. They recommend the combination of bamlanivimab/estesevimab as an alternative for high-risk outpatients over 12 years of age who weigh at least 40kg. High risk criteria included a BMI ≥35, chronic kidney disease, sickle cell disease, diabetes, patients on immunosuppressives, and more. The full fact sheet for providers can be found here. This document includes indication, dosing, preparation, and administration. The Emergency Use Authorization for bamlanivimab/estesevimab can be found here.
- FDA Fact Sheet for Health Care Providers: Emergency Use Authorization of Bamlanivimab and Estesevimab. https://www.fda.gov/media/145802/download
- The Emergency Use Authorization for bamlanivimab/estesevimab can be found here. Note that this is more general information, and the Fact Sheet for Health Care Providers provides more details.