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Abdominal Pain, Diarrhea in COVID-19 Linked to H pylori Infection

Among patients with coronavirus disease 2019 (COVID-19) who experience abdominal pain and diarrhea, there is a significant likelihood of Helicobacter pylori (H pylori) infection, according to the results of a study published in the Journal of Pediatric Gastroenterology and Nutrition.1

It is currently understood that severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), binds angiotensin-converting enzyme-2 (ACE-2) receptors.2 These receptors are highly expressed in the intestine, suggesting that SARS-CoV-2 infection may lead to gastrointestinal symptoms among patients with COVID-19.

As H pylori increases ACE-2 receptor expression in the gastrointestinal tract, a group of researchers in Turkey conducted an investigation from June 1, 2020, to July 20, 2020 to determine the effects of H pylori on the clinical presentation and course of COVID-19 infections.1

Patients who were COVID-19 positive, confirmed via polymerase chain reaction, were included in the analysis. Stool samples were collected and the presence of H pylori was determined via antigen screening tests.


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A total of 108 patients (mean age, 49.54 years) were included in the analysis: 77 patients tested negative for H pylori infection and 31 patients tested positive. Compared with patients who tested negative, patients with H pylori infection had significantly more frequent abdominal pain (P =.007) and diarrhea (P =.006). However, COVID-19 severity, outcomes of the disease, and the number of hospitalized days were not significantly associated with H pylori infection.

The investigators noted that the association between H pylori infection and abdominal pain and diarrhea in patients with COVID-19 is mediated by ACE-2 receptors. “[T]here is an urgent need for studies investigating the presence of H pylori and the expression of ACE-2 receptors in the lungs and upper respiratory system,” the investigators noted.1

References

  1. Balamtekin N, Artuk C, Arslan M, Gülşen M. The effect of Helicobacter pylori on the presentation and clinical course of coronavirus disease 2019 infection. JPGN. 2021;72(4):511-513. doi: 10.1097/MPG.0000000000003005
  2. Lan J, Ge J, Yu J, et al. Structure of the SARS-CoV-2 spike receptor-binding domain bound to the ACE2 receptorNature. 2020;581(7807):215–220. doi. 10.1038/s41586-020-2180-5

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Impact of the COVID-19 Pandemic on Adolescent Mental Health

Even before the COVID-19 pandemic began, concerning mental health trends and major treatment gaps were noted among adolescents in the United States. According to data from the National Survey on Drug Use and Health, an estimated 13.3% of US adolescents aged 12-17 experienced at least 1 episode of major depressive disorder in 2017, yet 60.1% of these individuals did not receive treatment for their illness.1

In addition, survey results from the Centers for Disease Control and Prevention demonstrated increasing rates of US high school students experiencing persistent sadness or hopelessness (from approximately 26% in 2009 to 37% in 2019), serious contemplation of suicide (from 14% to 19%), suicide planning (from 11% to 16%), and suicide attempts (from 6% to 9%). The highest risk levels were observed for White, female, and sexual minority students compared with non-White, male, and heterosexual students.2

Early findings indicate that these issues are being further exacerbated by the current crisis, with an especially high risk of worsening mental health among individuals with pre-existing psychological problems. These results have shown increased symptoms of depression, anxiety, and post-traumatic stress disorder among youth of various age groups.3,5 “The number, severity and duration of these symptoms are influenced by age, history of trauma, psychological status before the event, hours spent watching media coverage of the event, having a family member who died and the presence or absence of social and economic supports,” wrote Hertz and Barrios in a paper published in February 2021 in Injury Prevention.2

They noted that school closures may reduce access to mental health screening and care for vulnerable students, considering the large number of adolescents — nearly 3.5 million in 2018 — receiving such services in educational settings.2 These settings represent the only source of mental health services for many adolescents, particularly those from low‐income households and racial and ethnic minority groups. The authors thus emphasized the heightened importance of collaboration between schools and community health professionals to address the growing mental health needs of students.


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Adolescents and other youth are also affected by the impact of the pandemic on their caregivers, including unemployment, financial and emotional stress, and fear of infection, highlighting the need for adults to receive adequate care and support as well.6,7 Some youth have been forced to spend more time in abusive or otherwise dysfunctional homes due to quarantine requirements.

“Assessing the relative safety of a child at home is one of the major challenges posed to mental health professionals during a pandemic,” according to a November 2020 paper co-authored by Cécile Rousseau, MD, researcher, psychiatrist, and professor in the division of social and transcultural psychiatry at McGill University in Montreal, Canada.6 “Fueled by parental stress and in the absence of the benevolent gaze of the school or daycare, the risk of maltreatment is increasing as the rate of cases reported to youth protection is decreasing.”

Providers at hospitals across the US are reporting alarming increases in rates of attempted and completed suicides among youth — especially teenagers. One school district in Las Vegas has lost 19 children to suicide since the pandemic began. Regarding the increasing number of pediatric patients presenting to hospitals nationwide with suicidal ideation, clinicians have described them as having “worse mental states” compared to similar patients typically seen before the pandemic.8

Such trends underscore the vital importance of youth outreach and creative intervention and support during these times. Mental health providers “must continue to advocate to ensure that families and children get the mental health support that they need to support resilience, to decrease family conflict and child maltreatment, and to decrease risk-taking, unsafe, and dangerous behaviors,” as stated in the November 2020 article.6

We recently interviewed Dr Rousseau to further discuss these issues and potential solutions.

Cécile Rousseau, MD

What are believed to be the reasons for the generally low rates of mental health treatment among adolescents even pre-pandemic?

I believe there are 2 main reasons: First, MH services are overall difficult to access and often not very user-friendly for youth. Although some emerging models are addressing this, they are not generalized. Second, there is a widespread tendency to confound psychological distress and its expression — through sadness, anxiety, and anger — and mental disorder.

The first is associated with life being hurtful, which is very common, while the second is associated with more individual vulnerabilities. Of course, the 2 phenomena overlap, but in past times, distress was not medicalized or an object of treatment. Rather, it was addressed through interpersonal networks, spirituality, and so on. In the past decades there has been a shift in paradigm.

How has the pandemic affected and exacerbated mental health issues in this population?

The pandemic has generated first an acute stress response — which is normal, with fear and panic reactions, among others. To a certain extent, this has supported adherence to public health measures. As time passes, this becomes a chronic stress reaction with predominant avoidance symptoms such as denial and minimization of the pandemic risk. Frustration and anger regarding constraints have also increased, leading to scapegoating through conspiracy theories, and to legitimation of violence.

These are widespread reactions, which are not within the disorder range. For many people with vulnerabilities, however, the pandemic has exacerbated their symptoms, except for some cases of phobia — particularly school phobia — or cyberdependence, as these individuals may enjoy the confinement.

What are the relevant recommendations for clinicians about how to address these issues in practice and advocate for their adolescent patients?

Clinically, outreach to our patients to maintain continuity of care is crucial. In cases of frequent family conflict, virtual care should be used cautiously as it may not provide the needed confidentiality and safety and may aggravate the family conflict in some cases.

For new cases, management should include decreasing the impact of the collateral consequences of the pandemic — most commonly from social isolation and lack of stimulation — on adolescents’ development.

What are some of the broader, longer-term solutions that are also warranted?

Schools and colleges should be at the forefront of prevention. In Canada, pediatricians have advocated for the return of youth to school and the preservation of their social network (not partying, of course!). Youth need their peers to pursue their individuation-separation task, and this has been made impossible during confinement. We need to find a balance between the security of the elderly and the fulfillment of adolescent developmental needs.

References

  1. Major depression. National Institute of Mental Health. Updated February 2019. Accessed online February 7, 2021. https://www.nimh.nih.gov/health/statistics/major-depression.shtml
  2. Hertz MF, Barrios LC. Adolescent mental health, COVID-19, and the value of school-community partnerships. Inj Prev. 2021;27(1):85-86. doi:10.1136/injuryprev-2020-044050
  3. Rogers AA, Ha T, Ockey S. Adolescents’ perceived socio-emotional impact of COVID-19 and implications for mental health: results from a U.S.-based mixed-methods study. J Adolesc Health. 2021;68(1):43-52. doi:10.1016/j.jadohealth.2020.09.039
  4. Liang L, Ren H, Cao R, et al. The effect of COVID-19 on youth mental healthPsychiatr Q. 2020;91(3):841-852. doi:10.1007/s11126-020-09744-3
  5. Ma Z, Zhao J, Li Y, et al. Mental health problems and correlates among 746 217 college students during the coronavirus disease 2019 outbreak in China. Epidemiol Psychiatr Sci. 2020;29:e181. doi:10.1017/S2045796020000931
  6. Rousseau C, Miconi D. Protecting youth mental health during the COVID-19 pandemic: a challenging engagement and learning process. J Am Acad Child Adolesc Psychiatry. 2020;59(11):1203-1207. doi:10.1016/j.jaac.2020.08.007
  7. Chatterjee R. Make space, listen, offer hope: How to help a suicidal teen or child. NPR. Published online February 2, 2021. Accessed online February 7, 2021. https://www.npr.org/sections/health-shots/2021/02/02/962185779/make-space-listen-offer-hope-how-to-help-a-child-at-risk-of-suicide
  8. Chatterjee R. Child psychiatrists warn that the pandemic may be driving up kids’ suicide risk. NPR. Published online February 2, 2021. Accessed online February 7, 2021. https://www.npr.org/sections/health-shots/2021/02/02/962060105/child-psychiatrists-warn-that-the-pandemic-may-be-driving-up-kids-suicide-risk

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New Guidance: American College of Physicians Discusses Antibody Response in COVID-19 Immunity

Because of the novelty of the coronavirus that causes COVID-19, there is not enough evidence to determine whether antibodies produced after exposure are protective against reinfection. As such, the American College of Physicians (ACP) published rapid, evidence-based living practice points in the Annals of Internal Medicine discussing the role of antibodies in, tests for diagnosing, and tests for estimating the prevalence of COVID-19.

Practice Point 1: Antibody Tests for COVID-19 Diagnosis

The ACP does not recommend using SARS-CoV-2 antibody tests to diagnose COVID-19. This recommendation is based on the limited evidence that suggests not all patients with COVID-19 develop antibodies early in the course of their infection, as the presence and levels of antibodies can vary across patients and be dictated by certain disease characteristics.

The guideline panel adds that clinicians and patients should be mindful that some SARS-CoV-2 antibody tests may provide false-positive results, which are caused by cross-reactivity with antibodies of other coronaviruses.


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Studies also suggest that the sensitivity, specificity, and accuracy of currently available antibody tests widely vary, further complicating their use as reliable diagnostic tools. Variation in the sensitivity and specificity of these tests can also contribute to both false-negative and false-positive results, leading to inaccurate conclusions about infection and possibly inappropriate or insufficient treatment.

Practice Point 2: Antibody Tests for Estimating Community Prevalence

Studies suggest that patients develop immune responses following exposure to the novel coronavirus. The evidence shows immunoglobulin (Ig)A and IgM antibodies are detectable in the majority of patients who are infected with the SARS-CoV-2 virus. Nearly all patients also demonstrate detectable IgG and neutralizing antibodies.

Over time, the prevalence and levels of these antibodies may vary by different patient characteristics, disease symptoms, and disease severity. On average, the levels of each of the antibody types peak between 20 to 31 days following symptom onset or polymerase chain reaction diagnosis. Studies also show that the IgM antibodies may persist for up to 115 days and neutralizing antibodies may persist up to 152 days. Therefore, the ACP notes that antibody tests could be feasible options for estimating community prevalence of COVID-19.

Practice Point 3: The Protective Effect of SARS-CoV-2 Antibodies Against Reinfection

There is a paucity of evidence to suggest that natural immunity is conferred by SARS-CoV-2 antibodies. There is no evidence to suggest SARS-CoV-2 antibodies can predict the presence, level, or durability of any conferred natural immunity, especially as it relates to protection against reinfection.

Given that most patients exhibit detectable antibodies at least 100 days after infection, it may be plausible that natural immunity can occur. However, the panel reiterates that there is no direct evidence to answer the question of whether these antibodies can protect against reinfection.

Some literature indicates that both asymptomatic and symptomatic patients can develop an antibody response indicative of natural immunity following COVID-19, but variables such as disease severity, patient factors, type and amount of antibodies developed, as well as the longevity of those antibodies, play an important role.

The guideline panel cites a small study of hospitalized patients with COVID-19 that reported a single possible case of reinfection during the convalescence stage. This patient did not have IgM or IgG antibodies detected at the 4-week follow-up period.

Limitations of the Practice Points

According to the guideline authors, the practice points presented concern only the antibody-mediated natural immunity response in COVID-19 and do not particularly address the involvement of other natural immune responses, including cell-mediated immunity or vaccine-acquired immunity.

Currently, the only evidence-based recommendation for increasing immunity to the SARS-CoV-2 virus and preventing infection is to receive an authorized COVID-19 vaccine. Additional prevention strategies recommended in the guideline include social distancing, wearing a mask in public, quarantining, and regular hand washing.

“Given limited knowledge about the association between antibody levels and natural immunity,” the guideline authors wrote, “patients with SARS-CoV-2 infection and those with a history of SARS-CoV-2 infection should follow recommended infection prevention and control procedures to slow and reduce the transmission of SARS-CoV-2.”

Reference:

Qaseem A, Yost J, Etxeandia-Ikobaltzeta I, et al; for the Scientific Medical Policy Committee of the American College of Physicians. What is the antibody response and role in conferring natural immunity after SARS-CoV-2 infection? Rapid, living practice points from the American College of Physicians (version 1). Ann Intern Med. Published online March 16, 2021. doi:10.7326/M20-7569

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Venous Thromboembolism Management in Patients With COVID-19

The severe systemic inflammatory processes and hypercoagulability occurring with COVID-19 illness increase the risk for atherosclerotic plaque disruption and acute myocardial infarction (AMI). Patients with a previous history of coronary disease and/or other significant comorbidities are particularly predisposed to cardiovascular complications with COVID-19 infection.1 In this installment, we will discuss a patient with COVID-19 and venous thromboembolism.

Case Presentation

A 61-year-old woman presents to a rural emergency department with complaints of progressively worsening dyspnea over the past 24 hours and pleuritic chest pain. On initial presentation, the patient is hypoxic with an oxygen saturation of 92% on 5 L/min supplemental oxygen via nasal cannula and exhibits sinus tachycardia (130-140 beats per minute).

The patient’s COVID-19 polymerase chain reaction (PCR) test is positive. Blood work reveals D-dimer is 3 times higher than normal (<0.4 mcg/mL), initial troponin within normal limits (0-0.1 ng/mL), hemoglobin 10.7 g/dL, hematocrit 33.1%, and platelet count 172 ×10/µL.

A massive saddle pulmonary emboli (PE) is present on spiral computed tomography (CT) arteriography with intravenous contrast of the pulmonary arteries. Echocardiogram demonstrates acute cor pulmonale with a right ventricular (RV) to left ventricular (LV) diameter ratio of 1.4. Venous ultrasound reveals a nonocclusive popliteal venous thromboembolism.


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The patient is given full-dose enoxaparin and is transferred to an acute care cardiac specialty hospital for further treatment. Upon arrival at the specialty hospital, she is taken to the catheterization laboratory where a right and left pulmonary angiogram is performed with thrombectomy of the right and left pulmonary arteries.

Significant Medical History

The patient’s medical history includes type 2 diabetes mellitus, hypertension, dyslipidemia, hypothyroidism, and a 60-pack/year history of smoking.

Physical Examination

The patient is a middle-aged woman with obesity who is in acute respiratory distress. She has labored breathing and is tachypneic, with a respiratory rate in the mid-30s. Lung examination reveals mild expiratory wheezing bilaterally; a cardiac summation gallop is noted.

Electrocardiography (ECG) monitoring may indicate findings of cor pulmonale (right-sided heart failure) identified by a new incomplete or complete right bundle branch block, right axis deviation, or right ventricular ischemia with ST-segment depression in right pericardial leads. Monitoring with ECG also helps with evaluating for atrial arrhythmias such as atrial fibrillation commonly seen with PE.1

Spiral CT arteriography of the chest with contrast is ordered to rule out pulmonary embolus, which can be a contributing factor to respiratory symptoms, elevation in biomarkers, and a sequela of COVID-19 infection.3

Ultrasound of the lower extremities (bilaterally) is used to rule out deep vein thrombosis (DVT) in the lower extremities.

Diagnosis

The gold standard for confirmation of a PE is a spiral CT with arteriography. In this case, the test confirmed the presence of a massive saddle pulmonary embolus. Minimally invasive intervention is indicated if the patient is found to have right ventricular strain on echocardiogram (Table 1).

Table 1. Recommended Diagnostic/Laboratory Tests

Coagulation: elevation in PT/INR, D-dimer, platelet count, fibrinogen
Cardiac biomarkers: troponin
Factor V Leiden mutation
Prothrombin gene mutation
Anticardiolipin antibodies (including lupus anticoagulant)
Hyperhomocysteinemia (usually due to folate deficiency)1,2
PT/INR, prothrombin time/international normalized radio

Radionuclide lung scan, commonly known as ventilation-perfusion (VQ) scan, may serve as a diagnostic tool for inpatients who have elevation in renal indices and are not able to undergo contrast studies. A VQ scan with a high clinical suspicion confirms the diagnosis of PE in 40% of cases.1

Echocardiogram is a useful tool for performing risk stratification. The presence of right ventricular wall akinesis or hypokinesis with sparing of the apex has a high specificity for acute PE. Also, in cases of PE, the ratio of the right ventricular end-diastolic area (RVEDA) to left ventricular end-diastolic area (LVEDA) exceeds the upper limit of normal, which is 0.6 mm.1

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Potential Drug Interaction Between Warfarin, COVID-19 Treatment Reported

A probable drug interaction was observed in 2 patients taking warfarin who were initiated on remdesivir and dexamethasone for the treatment of COVID-19, according to a case series recently published in the Journal of Pharmacy Practice.

The patients, a 71-year-old man and a 62 year-old-man, both on long-term warfarin therapy, presented to the emergency department with symptoms of COVID-19. Per the report, each patient’s international normalized ratio (INR) was within their specific goal and both denied any diet, lifestyle, or medication changes prior to admission.

“During admission, both patients experienced a marked elevation in INR within 24 to 48 hours of the initiation of remdesivir with dexamethasone for COVID-19 pneumonia directed therapy,” the authors reported. After several days of modification to their warfarin doses, both patients were stable enough for discharge and were counseled to continue monitoring per the instructions of their outpatient pharmacist.

Although the exact mechanism of action resulting in the interaction between dexamethasone, remdesivir, and warfarin is unknown, the authors concluded that there is potential for interaction based on a calculated Drug Interaction Probability Scale score of 5. “This probable interaction is demonstrated by marked INR elevations within 24 to 48 hours of initiation of the combination in 2 cases with patients with historically stable INR history,” the authors stated.


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Reference

Landayan RP, Saint-Felix S, Williams A. Probable interaction between warfarin and the combination of remdesivir with dexamethasone for coronavirus disease 2019 (COVID-19) treatment: A 2 case report. J. Pharm. Pract. [Published online April 5, 2021]. doi: 10.1177/08971900211008623

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Inflammatory Heart Disease Prevalence in Professional Athletes With Prior COVID-19 Infection

Among professional athletes who have tested positive for coronavirus disease 2019 (COVID-19 infection 0.6% had imaging findings suggestive of inflammatory heart disease that resulted in restriction from participation, according to a screening protocol based on American Heart Association (AHA)/American College of Cardiology (ACC) guidelines, researchers reported in JAMA Cardiology.

In May 2020, a number of major North American professional sports leagues —including Major League Soccer, Major League Baseball, the National Hockey League, the National Football League, and the men’s and women’s National Basketball Association — implemented a conservative return-to-play (RTP) cardiac testing program according to the AHA/ACC recommendations for all athletes who test positive for severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2), the virus that causes COVID-19. In this cross-sectional study, investigators sought to assess the prevalence of detectable inflammatory heart disease in professional athletes with prior SARS-CoV-2 infection in accordance with the current RTP screening recommendations.

The analysis included 789 professional athletes who tested positive for SARS-CoV-2 from May 2020 to October 2020 and underwent RTP cardiac screening. The mean age of the cohort was 25±3 (range, 19-41) years, and 777 (98.5%) were men. Among the athletes, 460 (58.3%) had previous symptomatic COVID-19 illness, and 329 (41.7%) were asymptomatic or paucisymptomatic but had tested positive for SARS-CoV-2.

SARS-CoV-2 positivity was diagnosed by polymerase chain reaction (PCR) assay in 587 (74.4%) athletes and antibody testing in 202 (25.6%) athletes. For athletes who tested positive for SARS-CoV-2 with PCR assay, cardiac screening was performed a mean of 19±17 (range, 3-156) days after the positive SARS-CoV-2 test.


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A total of 30 athletes had initial abnormal screening results and were sent for additional testing. Cardiac magnetic resonance imaging (CMR) was performed in 27 athletes in this group. Downstream testing confirmed diagnosis of inflammatory heart disease in 5 (18.5%) of the 27 athletes (0.6% of the total cohort); 3 athletes had CMR-confirmed myocarditis (0.4% of the total cohort), and 2 athletes had CMR-confirmed pericarditis (0.3% of the total cohort).

The athletes with confirmed inflammatory heart disease were held out from participation in their sport according to the RTP screening recommendations. The remaining 25 (83.3%) athletes who underwent additional testing ultimately did not have findings that suggested acute cardiac injury and returned to play. No clinical cardiac events have occurred in any of the athletes who had cardiac screening and resumed full professional sporting activity, as of late December 2020.

This study has important limitations, according to the researchers. RTP screening examinations were performed in a clinical setting and were usually analyzed and adjudicated by team physicians and cardiologists across the United States and Canada, which may lead to varying determinations of potential cardiac pathology and need for downstream testing. There was also variability in the time between SARS-CoV-2 testing and cardiac screening, and 98.5% of the athletes were men.

“We observed only rare cases of athletes having potential cardiac involvement,” stated the study authors. “This reporting of systematic RTP cardiac screening, while not generalizable to all athletic populations, can provide clinical guidance for other athletic organizations who are preparing and optimizing RTP protocols.”

Disclosures: Some of the authors reported affiliations with sports leagues, associations, and teams. Please see the original reference for a full list of disclosures.

Reference

Martinez MW, Tucker AM, Bloom OJ, et al. Prevalence of inflammatory heart disease among professional athletes with prior COVID-19 infection who received systematic return-to-play cardiac screening. JAMA Cardiol. Published online March 4, 2021. doi: 10.1001/jamacardio.2021.0565

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Vitamin D Supplementation May Lead to Small Risk Reduction for Acute Respiratory Infections

Vitamin D supplementation may safely reduce the overall risk for acute respiratory infection compared with placebo, but the risk reduction is small and the relevance of these findings to coronavirus disease 2019 (COVID-19) is unknown and requires additional investigation. This is according to research published in Lancet Diabetes Endocrinology.

Since the COVID-19 pandemic began, interest in the role of vitamin D in reducing acute respiratory infections has increased. Results of randomized controlled trials, though, have been heterogenous and variable, with some demonstrating protection and others reporting findings that are null. Results of a 2017 meta-analysis indicated the potential protective effect of vitamin D supplementation. Researchers sought to build on those results by conducting a new systematic review and meta-analysis of studies conducted since December 31, 2015.

The primary study outcome was the proportion of patients who had one or more acute respiratory infection (upper, lower, or location unclassified). Secondary outcomes included the proportion of participants who experienced one or more upper or lower respiratory infection, emergency department visit, hospitalization, or both for an acute respiratory infection, death due to acute respiratory infection or respiratory failure, antibiotic use, absence from school or work, serious adverse events, death, and potential adverse reactions to vitamin D.

The analysis included 46 studies representing 75,541 patients. Thirty-five studies compared the effects of vitamin D regimen with placebo, 5 compared higher- and lower-dose vitamin D with placebo groups, and 6 compared the effects of higher dose vitamin D with lower-dose vitamin D regimens.


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Primary outcome data were obtained for 98.1% of 49,419 available participants.

In the 35 studies that measured baseline 25(OH)D concentrations, mean levels ranged from 18.9 to 90.9 nmol/L. Across studies, vitamin D was administered through variable routes, including oral dosing, weekly dosing, bolus dosing once every month to once every 3 months, and combination bolus and daily dosing.

A significantly lower proportion of participants who were taking vitamin D supplements had 1 or more acute respiratory infections compared with those taking placebos (61.3% vs 62.3%; odds ratio [OR], 0.92; 95% CI, 0.86-0.99). The heterogeneity effect for these data was moderate (I2=35.6%).

For secondary comparisons of high vs low dose vitamin D supplementation, no significant differences in the proportion of at least one acute respiratory infection was noted between participant groups (68.2% vs 64.6%; OR, 0.87; 95% CI, 0.73-1.04; I2=0.0%).

In order to investigate the reasons for the heterogeneity of the effect for the primary comparison (vitamin D vs placebo), researchers conducted an analysis stratified by 2 participant level factors (baseline 25(OH)D concentration and age) and 4 trial-level factors (dose, dose frequency, trial duration, and presence or absence of airway disease). Four of these factors—baseline 25(OH)D concentration, dose, dose frequency, and trial duration—were prespecified in study protocols and two—age and presence or absence of airway infections—were exploratory analyses.

Compared with placebo groups, there was no significant effect of vitamin D supplementation on the risk of having 1 or more acute respiratory infection in participants with baseline 25(OH)D concentrations of less than 25 nmol/L, 25 to 49.9 nmol/L, 50 to 74.9 nmol/L, or greater than 75 nmol/L (ORs, 0.81, 1.04, 0.88, 0.76, and 1.00, respectively).

A significant protective effect of vitamin D supplementation was seen on the risk for developing one or more acute respiratory infection compared with placebo, particularly in trials where vitamin D was given daily (OR 0.78) compared with weekly dosing or bolus dosing once a month or once every 3 months (ORs, 0.97 and 0.98).

Significant protective effects were also noted against the risk of having one or more acute respiratory infection vs placebo in trials that were not restricted only to participants with asthma or chronic obstructive pulmonary disease (COPD).

The meta-analysis for secondary outcomes included only the results of placebo-controlled trials. Without considering participant- or trial-level factors, vitamin D supplementation did not demonstrate a significant effect on the proportion of participants who experienced 1 or more upper or lower respiratory infection, used antibiotics to treat an infection, reported absence from school or work, or had been admitted to the hospital, or who went to the emergency department.

Study limitations include the analysis of aggregate trial-level, rather than individual participant-level data due to the need for results in the face of the COVID-19 pandemic, a lack of participant-level data on race, ethnicity, or obesity as potential effect-modifiers, and an inability to account for other factors that might influence the protective effect of supplementation.

“This updated meta-analysis…showed a significant overall protective effect of this intervention compared with a placebo control,” the researchers wrote. “In contrast to findings of our previous meta-analysis of individual participant-level data, we did not see a protective effect…among participants with the lowest baseline 25(OH)D concentrations.”

“The vitamin D dosing regimen of most benefit was daily and used standard doses (400-1000 IU) for up to 12 months. The relevance of these findings to COVID-19 is not known and requires further investigation,” they concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Jolliffe DA, Camargo Jr CA, Sluyter JD, et al. Vitamin D supplementation to prevent acute respiratory infections: A systematic review and meta-analysis of aggregate data from randomized controlled trials. Published online March 30, 2021. Lancet Diabetes Endocrinol. doi: 10.1016/S2213-8587(21)00051-6.

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Patients With Underlying Medical Conditions Now a Priority for COVID-19 Vaccination

In March, the Centers for Disease Control and Prevention (CDC) announced that it would prioritize all patients with diabetes for COVID-19 vaccinations—a decision that was applauded by the American Diabetes Association which sought to reverse a previous guidance that didn’t prioritize all diabetes patients.

“The updated recommendation is a welcome change for the nearly 1.6 million Americans who have type 1 diabetes, many of whom were left behind—even if inadvertently—by the CDC’s previous guidance,” said Tracey D. Brown, the chief executive officer for the American Diabetes Association (ADA). “We know people with diabetes account for nearly 40 percent of all COVID-19 related deaths. Having the CDC acknowledge the serious risk to all people with diabetes from COVID-19 will go a long way toward boosting increasing access to the vaccine for our community at a critical time. It is crucial that remaining states follow suit. The science and the CDC recommendation leave no doubt that all people with diabetes should be prioritized equally.”

As part of the CDC’s phase 1c COVID-19 vaccine rollout that began in March, the CDC recommends that all patients between 16 and 64 years old with underlying medical conditions receive a COVID-19 vaccine. In addition to patients with type 1 or type 2 diabetes, the list includes patients with cancer, chronic kidney disease, chronic lung diseases (including chronic obstructive pulmonary disease, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension), dementia or other neurological conditions, Down syndrome, cardiovascular conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension), HIV infection, patients with immunodeficiency, liver disease, obesity, sickle cell disease or thalassemia, stroke or cerebrovascular disease, among other conditions.

Clinicians should use their judgment and may recommend patients for vaccination even if their underlying medical condition is not included on the list. “Studies have shown that COVID-19 does not affect all population groups equally. The risk of severe COVID-19 increases as the number of underlying medical conditions increases in an individual. Some chronic medical conditions occur more frequently or at a younger age in racial or ethnic minority populations,” the CDC stated in a report published on its website.


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According to a study published in JAMA Network Open by Ning Rosenthal, MD, MPH, PhD, of Premier Applied Sciences, North Carolina, 70.1% of inpatients and 25.1% of outpatients with COVID-19 had at least one comorbidity with the most common being hypertension (30,236 [46.7%]), hyperlipidemia (18,744 [28.9%]), diabetes (18,091 [27.9%]), and chronic pulmonary disease (10,434 [16.1%]). Old age of at least 80 years was found to be the risk factor most often associated with death which applied to 20.3% of inpatients in the Rosenthal et al. study.

Still, pre-existing comorbidities were associated with a higher risk of mortality for patients who were admitted to the hospital for COVID-19 treatment. Rosenthal et al. found that COVID-19 patients with a metastatic solid tumor had a 57% higher risk of inhospital mortality as compared to patients with a history of myocardial infarction (47% increase), patients with cerebrovascular disease (39% increase), congestive heart failure (37% increase), hemiplegia (34% increase), any malignant neoplasm (27% increase), dementia (20% increase), diabetes (20% increase), chronic pulmonary disease (16% increase), and hyperlipidemia (11% increase). The presence of multiple comorbidities was associated with a higher risk of in hospital mortality.

In a review of 235 studies on COVID-19 and its effect on patients with pre-existing comorbidities, the CDC concluded that based on the meta-analysis and systematic reviews included in the CDC review, only nine conditions were found to have a significant association with risk of severe COVID-19 illness. These include cancer, cerebrovascular disease, chronic kidney disease, COPD (chronic obstructive pulmonary disease), diabetes mellitus (type 1 and type 2), cardiovascular conditions (such as heart failure, coronary artery disease, or cardiomyopathies), obesity (BMI ≥30 kg/m2), pregnancy, and a history of smoking or current smokers. Studies that identified other comorbidities said to be a high risk for mortality or severe illness were mostly observational or as a result of case reports.

THE DIABETES PATIENT

Writing in Acta Diabetolgica in February, Qing Cheng of Huazhong University of Science and Technology in Wuhan, China, diabetes patients may be at higher risk of mortality and more severe COVID-19 prognosis possibly because insulin resistance ultimately stimulates the production of pro-inflammatory cytokines, oxidative stress, and adhesion molecules.

“Infection leads to destruction of pancreatic beta cells, decreased pancreatic insulin content, and changes in the host’s ability to respond normally to glucose tolerance tests,” Cheng et al. wrote in the study.

Drs. Rimesh Pal and Sanjay K. Bhadada—two endocrinologist from India—writing in Diabetes & Metabolic Syndrome:  Clinical Review & Reviews, described the physiological disease process between diabetes mellitus and COVID-19 as a “vicious cycle.”

“The two-way interaction between COVID-19 and diabetes mellitus sets up a vicious cycle wherein COVID-19 leads to worsening of dysglycemia and diabetes mellitus, in turn, exacerbates the severity of COVID-19. Thus, it is imperative that people with diabetes mellitus take all necessary precautions and ensure good glycemic control amid the ongoing pandemic,” they wrote.

Pal and Bhadada theorized that “compromised innate immunity, pro-inflammatory cytokine milieu, reduced expression of ACE2 and the use of renin-angiotensin-aldosterone system antagonists in people with diabetes mellitus contribute to poor prognosis in COVID-19. On the contrary, direct β-cell damage, cytokine-induced insulin resistance, hypokalemia and drugs used in the treatment of COVID-19 (like corticosteroids, lopinavir/ritonavir) can contribute to worsening of glucose control in people with diabetes mellitus.”

A panel of physicians writing in The Lancet in April 2020, issued a set of treatment recommendations for diabetes patients with COVID-19. For out-patient care, they recommend stressing to the patient the importance of achieving optimal metabolic control and they caution against prematurely stopping treatments diabetes patients are receiving.

For in-patient care, they recommend monitoring patients for new onset diabetes in patients who are infected with COVID-19.

For diabetes patients receiving in-patient care for COVID-19, routine monitoring should include plasma glucose monitoring, electrolytes, pH, blood ketones, or β-hydroxybutyrate, the panel wrote.

The ultimate goal for treatment should be:

·  Plasma glucose concentration: 4–8 mmol/L (72–144 mg/dL)

·  HbA1c:† less than 53 mmol/mol (7%)

·  CGM/FGM targets

·  TIR (3·9–10 mmol/L): more than 70% (>50% in frail and older people)

·  Hypoglycaemia (<3·9 mmol/L): less than 4% (<1% in frail and older people)

·  Plasma glucose concentration: 4–10 mmol/L (72–180 mg/dL)

For patients with type 2 diabetes and COVID-19, the panel warns against possible negative drug interactions. Patients taking metformin, for example, may experience dehydration and lactic acidosis so it may be necessary to temporarily stop taking the drug. These patients are at high risk of renal injury so renal function should be monitored.

Insulin therapy should not be stopped for patients with COVID-19 and diabetes. They should monitor blood-glucose every 2–4 hours or follow continuous glucose monitoring practices. Medicines should be adjusted, if appropriate, to reach therapeutic goals.

Patients taking sodium-glucose-co-transporter 2 inhibitors canagliflozin, dapagliflozin, and empagliflozin are at risk of dehydration and diabetic ketoacidosis, so they should temporarily stop taking these drugs should these symptoms occur.

Patients taking glucagon-like peptide-1 receptor agonists albiglutide, dulaglutide, exenatide-extended release, liraglutide, lixisenatide, and semaglutide are at risk of dehydration which can lead to a serious illness so they should adhere to strict fluid intake and a routine diet.

Dipeptidyl peptidase-4 inhibitors alogliptin, linagliptin, saxagliptin, and sitagliptin are generally well tolerated and can be continued.

“We do realize that all our recommendations and reflections are based on our expert opinion, awaiting the outcome of randomized clinical trials. Executing clinical trials under challenging circumstances has been proven feasible during the COVID-19 pandemic, and trial networks to provide evidence-based therapies are arising. Investigating subgroups with diabetes and how these relate to COVID-19 outcomes will be important, in particular investigating if some of the various management approaches would be particularly effective in managing diabetes in a COVID-19 context,” Bornstein et al. wrote.

For more information from the American Diabetes Association on COVID-19, visit the ADA’s COVID-19 hub (https://www.diabetes.org/coronavirus-covid-19) for vaccine plans by state.

Disclosures:

n/a

References

1. “American Diabetes Association Applauds CDC Decision to Prioritize All People with Diabetes for the COVID-19 Vaccine,” American Diabetes Association statement issued March 30, 2021 | Arlington, Virginia.

2. “COVID-19, People with Certain Medical Conditions,” Centers for Disease Control and Prevention, March 29, 2021.

3. “Underlying Medical Conditions Associated with High Risk for Severe COVID-19: Information for Healthcare Providers,” Centers for Disease Control and Prevention. Updated March 29, 2021. 

4. Ning Rosentha, MD, MPH, PhD; Zhun Cao, PhD; Jake Gundrum, MS; Jim Sianis, PharmD, MBA; Stella Safo, MD, MPH. “Risk Factors Associated With In-Hospital Mortality in a US National Sample of Patients With COVID-19,” JAMA Open Network. Dec. 10, 2020.  doi:10.1001/jamanetworkopen.2020.29058

5. “Science Brief: Evidence used to update the list of underlying medical conditions that increase a person’s risk of severe illness from COVID-19,” Centers for Disease Control and Prevention. March 29, 2021.

6. Zeng-hong Wu, Yun Tang, and Qing Cheng. “Diabetes increases the mortality of patients with COVID-19: a meta-analysis,” Acta Diabetolgica, a publication of Springer Nature. Received: 23 April 2020 / Accepted: 6 May 2020. Published Feb. 2021. https://doi.org/10.1007/s00592-020-01546-0  

7. Rimesh Pal, Sanjay K Bhadada. “COVID-19 and diabetes mellitus: An unholy interaction of two pandemics,” Diabetes & Metabolic Syndrome:  Clinical Review & Reviews. May 6, 2020. DOI: 10.1016/j.dsx.2020.04.049

8. Stefan R Bornstein, Francesco Rubino, Kamlesh Khunti, et al. “Practical recommendations for the management of diabetes in patients with COVID-19,” The Lancet. Published in print June 2020. Published online April 23, 2020. https://doi.org/10.1016/S2213-8587(20)30152-2  

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COVID-19 Home Collection Antibody Test Gets Emergency Use Authorization

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc), the first antibody test authorized for use with home collected dried blood spot samples.

The Symbiotica COVID-19 Self-Collected Antibody Test System is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The EUA allows for fingerstick dried blood samples to be self-collected at home by an individual 18 years of age and older or collected by an adult from an individual 5 years of age and older. The collected samples are then sent to a Symbiotica, Inc laboratory for analysis. The test is available only by prescription.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. 

The Agency cautioned that the Symbiotica COVID-19 Self-Collected Antibody Test System should not be used to diagnose or exclude acute SARS-CoV-2 infection. It is unknown at this time if the presence of antibodies confers immunity and how long antibodies persist after an infection.


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Reference

Coronavirus (COVID-19) update: FDA issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System. [press release]. Silver Spring, MD: US Food and Drug Administration; April 6, 2021. 

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COVID-19 Vaccination and Imaging Misinterpretation: An Interview With Lacey McIntosh, DO, MPH

The United States is, according to a recent declaration from President Joe Biden, aiming to offer all US adults vaccination against SARS-CoV-2, the virus that causes COVID-19, by May 2021.1 To date, furthermore, more than 30 people per 100 across the country have received at least 1 dose of a currently approved vaccine.2

The vaccination program is likely to improve overall survival in the population of patients with cancer, given the high risk of COVID-19-related mortality in this group. The clinical considerations related to vaccination in this population are, however, not yet established, and some research suggests that oncologists and patients should be aware of the potential manifestations of vaccination on imaging and the consequences this might have on disease assessment, treatment monitoring, and decision-making.

A recent article published in the American Journal of Roentgenology suggests that vaccination can result in axillary, supraclavicular, and/or cervical lymph node enlargement on the side of the injection. Such enlargement may, according to the authors, lead to confounding results and/or even misinterpretation of fluorodeoxyglucose (FDG) positron emission tomographic/computer tomographic (PET/CT) imaging in some cases.

While lymphadenopathy has previously been reported with other vaccines, notably those against seasonal influenza and human papillomavirus, the widespread use of SARS-CoV-2 vaccination necessitates awareness in the clinical community of the potential for confounding findings on imaging, in particular with FDG PET/CT. Clinician awareness of vaccine site and timing can be useful with coordination of imaging to help avoid these manifestations that can, in some cases, interfere with the accuracy of the examinations. Yet given the number of patients with cancer who have received — or are likely to soon receive — vaccination, some scans may not be interpretable, leading to treatment indecision in the face of potentially aggressive disease.


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To this end, Lacey McIntosh, DO, MPH, assistant professor at the University of Massachusetts Medical School in Worcester, and the study’s first author, discussed the implications of this research.

What is the dilemma with performing PET/CT in patients who have been recently vaccinated against COVID-19?

Dr McIntosh: The diagnostic dilemma that we are encountering is that the imaging manifestations of a recent COVID-19 vaccine can mimic cancer, especially on PET/CT. The vaccine causes tracer uptake and sometimes enlargement of lymph nodes of the axilla, supraclavicular region, and neck on the side of administration.

PET/CT is used for a variety of indications in oncology, including lesion characterization, disease staging, monitoring response to treatment, and surveillance for recurrence. Often, treatment decisions and disease status rely heavily on the results of this imaging. These studies can be difficult for physicians to get for their patients, so we want to make sure that when they are done, they are done well and give us the best chance to get the information we need with clear results.

In some cases, a recent vaccine just prior to imaging can potentially result in confusing findings rendering the study not useful and even lead to misinterpretation if information about vaccination is not available to the reading radiologist.

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