COVID-19 Update: March 11th - March 23rd
Welcome to the McGraw-Hill AccessMedicine COVID-19 channel. This week we have information on the use of the SOFA score in COVID-19, information on the lack of benefit of a single dose of Vitamin D in those hospitalized with COVID-19, new guidelines on nursing home visits, a change in the CDC recommendations about returning to school in a safe fashion and an FDA warning about false positive SARS-CoV-2 (and influenza) results with one of Roche’s testing kits.
The Sequential Organ Failure Assessment (SOFA) score is a poor predictor of outcome in intubated patients with COVID-19. The SOFA score is a measurement of organ failure, which includes evaluation of pulmonary function, hepatic function, CNS function, renal function, coagulation function, and neurologic function. It is used in the ICU to determine which patients have a high risk of death.
This is a retrospective study of the predictive value of the SOFA score for mortality in sequential patients with COVID-19 pneumonia from 18 ICUs. All patients were intubated 4 or more hours after requiring oxygen therapy.
2,546 patients were screened, of whom 675 met the criteria for participation and had adequate documentation to allow the calculation of a SOFA score. They used the worst SOFA value within the 48-hours preceding intubation and calculated the area under the curve. 59% died or were admitted to hospice. The SOFA score performed poorly at predicting mortality (area under the curve of 0.55-0.63) and was a worse predictor than simply using age (area under the curve 0.62-0.70) p=0.02).
Trying to predict mortality is always a difficult endeavor and in intubated COVID-19 patients the pre-intubation SOFA score is not a good predictor of survival. This is important as we allocate vital resources such as ventilators. We should not use the pre-intubation SOFA score to decide who gets critical resources. The full study can be found here.
- Raschke RA, Agarwal S, Rangan P, Heise CW, Curry SC. Discriminant Accuracy of the SOFA Score for Determining the Probable Mortality of Patients With COVID-19 Pneumonia Requiring Mechanical Ventilation. Published online February 17, 2021. doi:10.1001/jama.2021.1545
A single high dose of Vitamin D administered to patients with “moderate to severe” COVID-19 failed to improve length of stay, mortality, admission to the intensive care unit, or need for mechanical ventilation. This was a randomized, double-blind, placebo-controlled trial of 240 patients with “moderate to severe” COVID-19 which looked at the effect of vitamin D on length of stay, mortality, need for intensive care, and need for mechanical ventilation. “Moderate to severe” was defined as, “respiratory rate greater than 24 breaths per minute, oxygen saturation less than 93% while breathing room air, or risk factors for complications” (e.g diabetes, obesity, hypertension, immunosuppression, etc.). One hundred and twenty patients received a single oral dose of vitamin D3 200,000 IU and 120 patients received placebo. After treatment, 87% of patients in the vitamin D group had a vitamin D level within the normal range compared to 11% in the control group.
There was no difference in outcomes in any domain. This includes the patients who were vitamin D deficient at baseline.
One weakness of this study is that only 62% of patients had PCR confirmed COVID-19; the rest of the diagnoses were made on clinical criteria (appropriate CT scan and an influenza like illness). Additionally, those getting vitamin D got only a single dose and it was administered after they were symptomatic. We still don’t know how vitamin D will perform in other settings. However, at least in this study population, there was no benefit. The full study can be found here.
- Murai IH, Fernandes AL, Sales LP, et al. Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients with Moderate to Severe COVID-19: A Randomized Clinical Trial. 2021;325(11):1053–1060. doi:10.1001/jama.2020.26848
The Centers for Medicare and Medicaid Services (CMS), along with the CDC, has relaxed guidelines for nursing home visits. The new guidelines allow for visitation with some restrictions. From the guidelines vebatim:
"Facilities should allow indoor visitation at all times and for all residents (regardless of vaccination status), except for a few circumstances when visitation should be limited due to a high risk of COVID-19 transmission (note: compassionate care visits should be permitted at all times).”
“These scenarios include limiting indoor visitation for:
- Unvaccinated residents, if the nursing home’s COVID-19 county positivity rate is >10% and <70% of residents in the facility are fully vaccinated.
- Residents with confirmed COVID-19 infection, whether vaccinated or unvaccinated until they have met the criteria to discontinue Transmission-Based Precautions (https://www.cdc.gov/infectioncontrol/basics/transmission-based-precautions.html); or
- Residents in quarantine, whether vaccinated or unvaccinated, until they have met criteria for release”
There are also specific recommendations for visitations when there is a new case of COVID-19 in a staff or resident. These are detailed and not easily summarized.
The guidelines note that outdoor visitation is preferred if possible. All basic infection control measures should remain in place, including mandatory mask wearing, social distancing of at least six feet, hand washing, surface cleaning and, resident and staff testing (see here), etc. Those interested should review the complete guideline, which is available here.
- CMS. “Nursing Home Visitation-COVID-19 (REVISED 3/10/2021). Available at https://www.cms.gov/files/document/qso-20-39-nh-revised.pdf
The CDC has updated the guideline for returning to in person learning in schools. These are nuanced and do not simply reduce physical distancing to three feet as has been reported in the United States press. The guideline recognizes the critical role of education including the social aspects of school such as food access and allowing parents to return to work. The overriding principle is to keep schools open if it is safe to do so. The guideline states that, “K–12 schools should be the last settings to close after all other prevention measures in the community have been employed, and the first to reopen when they can do so safely.” The guideline also stratifies recommendations based on local community transmission. Among the recommendations are:
Physical Distancing (verbatim with added emphasis)
- Between students in classrooms
- In elementary schools, students should be at least three feet apart.
- In middle schools and high schools, students should be at least three feet apart in areas of low, moderate, or substantial community transmission. In areas of high community transmission, middle and high school students should be six feet apart if cohorting is not possible.
Maintain six feet of distance in the following settings:
- Between adults (teachers and staff), and between adults and students, at all times in the school building. Several studies have found that transmission between staff is more common than transmission between students and staff, and among students, in schools.
- When masks cannot be worn, such as when eating.
- During activities when increased exhalation occurs, such as singing, shouting, band, or sports and exercise. Move these activities outdoors or to large, well-ventilated space, when possible.
- In common areas such as school lobbies and auditoriums.”
Other recommendations address the universal use of masks in the school as well as on school buses and other transportation (with exceptions for some students with disabilities), cohorting and maintaining six feet of distance between cohorts, increasing ventilation, including on school buses, having all desks facing the same direction and more.
Those interested should review the complete recommendation. You can find the full recommendation here.
- CDC. COVID-19: Operational Strategy for K-12 Schools through Phased Prevention. Updated 19 March 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strategy.html
The FDA is warning about false positive COVID-19 results in patients tested with the “Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System”. This is dues to two potential problems: leaking assay tubes which may cause a false positive influenza B and abnormal PCR cycling which may cause a false positive assay for influenza A, B or SARs-CoV-2. The recommendation is to:
- “Monitor for unexpected clusters of positive Flu B results, as this may indicate the cobas Liat System has experienced a tube leak.
- Repeat tests when two or three analytes are positive. Different results on the repeat test may indicate abnormal PCR cycling.
- Stop using the cobas Liat System and contact Roche if you suspect either of these two issues has occurred.”
- US FDA, Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers. Available at: https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-results-roche-molecular-systems-inc-cobas-sars-cov-2-influenza-test-use-cobas-liat