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Clinical Issues and Guidance

Promising Therapeutics

Study Weighs the Benefits of Use of Remdesivir in Critically Ill Patients

A newly published article in the New England Journal of Medicine reports on a small study of compassionate use of remdesivir in severely ill COVID-19 patients. Sponsored by the manufacturer—Gilead—the study was open-label, non-randomized, and non-controlled, which is interesting because this drug is currently in wide use. The study observes that clinical improvement was seen in 36 of 53 patients (68 percent) treated with remdesivir and calls for a randomized, controlled study.

Debate Regarding Use of Hydroxychloroquine Continues

The ongoing debate on use of chloroquine and hydroxychloroquine in the treatment of COVID-19 patients has become even more controversial with the publication of a small Brazilian study of high-dose chloroquine (12 grams total dose over 10 days) versus lower dose (total dose of 2.7 grams over five days) that showed higher cardiac toxicity (more prolongation of corrected QT interval [QTc] > 500ms and a trend to higher mortality). Confounding the results was the concomitant use of azithromycin in all these patients, which can also prolong QTc and cause cardiac arrhythmias. The high-dose treatment arm was halted prematurely because of the potential safety hazard. The study also showed a low clearance rate of respiratory virus in only one of 14 patients (7 percent).

Convalescent Plasma May Be Useful in Prevention and Treatment

A viewpoint article was published in the Journal of Clinical Investigation describing the use of convalescent plasma for prophylaxis and therapy. The authors argue that human convalescent plasma is an option for prevention and treatment of COVID-19 disease that could be rapidly available when there are sufficient numbers of people who have recovered and can donate immunoglobulin-containing plasma.

Emerging Treatment Protocols and Issues Surrounding Unique Aspects of COVID-19 Patients

As physicians gain more experience with COVID-19 patient management, treatment protocols and issues surrounding the unique aspects of these patients are becoming available. Among those issues are management of COVID-related acute respiratory distress syndrome (ARDS), management of COVID coagulopathy and its treatment, as well as specific issues surrounding cardiopulmonary resuscitation (CPR) in this highly contagious disease. The critical care group at Stony Brook, NY, gave an early report on use of anticoagulants in managing the COVID patient. Also, Lena M. Napolitano, MD, FACS, FCCP, FCCM, has provided the University of Michigan’s presentation  on the worldwide experience in COVID patient management. Finally, Dr. Lang offers a bullet-point summary and real-world tips on ventilation and the issues of CPR at the University of Washington Medical Center in Seattle.

Anticoagulation Strategies in Patients with COVID-19 Infection: Brief Commentary

Retrospective reviews of COVID-19 patients in China show that patients with severe infection developed disseminated intravascular coagulation, as reflected by elevated D-dimer, prolonged prothrombin time/international normalized ratio, partial thromboplastin time, decreased fibrinogen, and thrombocytopenia.

Of note, elevated D-dimer with three- to fourfold increase may be prognostic for severe COVID-19 infection, indicating the necessity for admission. Autopsy reports show microthrombi in the pulmonary vasculature, which may be an explanation for the acute respiratory distress syndrome-like clinical presentation.1,2 Tang and colleagues observed a decreased mortality rate in their cohort of patients who received anticoagulant treatment, primarily with low-molecular-weight heparin (LMWH),) during their clinical course.3 The increased risk of venous thromboembolism in severe COVID-19 is unclear.

The International Society of Thrombosis and Haemotology (ISTH) has provided interim guidance for management of COVID-19 coagulopathy based on these early reports from Wuhan, China.4 Current recommendations are for all COVID-19-positive patients to be treated with LMWH prophylaxis. Fondaparinux is recommended for patients with increased risk for bleeding. Therapeutic anticoagulation in COVID-19 is indicated only when a venous thromboembolism (VTE) is present or when a patient has been on anticoagulation for pre-existing VTE or atrial fibrillation. Additional guidance can be reviewed in this article. In our experience, we have seen COVID-19-positive patients clotting renal replacement circuits, lines, and some anecdotal experience in increasing VTEs. More data are needed to develop standardized care for these patients. We are learning as we go, and this process is fluid in nature.

References

  1. Luo W, Yu H, Gou J, Li X, Sun Y, Li J, Liu L. Clinical pathology of critical patient with novel coronavirus pneumonia (COVID-19). Preprints. 2020.
  2. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: A descriptive study. Lancet.2020;395: 507-513.
  3. Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost.2020.
  4. Thachil J, Tang N, Gando S, et al. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020.

University of Miami Study Discusses Potential Uses of Anticoagulation in COVID-19 Patients

Members of the University of Miami’s division of trauma surgery and surgical critical care team have published a review of anticoagulation use and recommendations for the treatment of a hypercoagulable state in those affected by COVID-19. The use of an anticoagulant appears to be associated with decreased mortality in all patients, but, more specifically, the use of heparin is discussed because of its anticoagulant, anti-inflammatory, and potential antiviral properties. Read the full report here.

Expert Medical Societies Release Multidisciplinary Recommendations for Breast Cancer Patient Care During COVID-19 Pandemic

The American Society of Breast Surgeons, the National Accreditation Program for Breast Centers, the National Comprehensive Cancer Network, the Commission on Cancer of the American College of Surgeons, and the American College of Radiology® have released new joint recommendations for prioritization, treatment, and triage of breast cancer patients during the COVID-19 pandemic.

University of Chicago Team Offers New System to Prioritize Operations

A team of investigators at the University of Chicago, IL, has devised a new scoring system that helps surgeons across surgical specialties decide when to proceed with medically necessary operations in the face of the resource constraints and increased risks posed by the COVID-19 pandemic. The process, called Medically Necessary Time-Sensitive (MeNTS) Prioritization, is published as an “article in press” on the Journal of the American College of Surgeons website ahead of print.

The MeNTS Prioritization process was created by a team of six representatives from general surgery, vascular surgery, surgical oncology, transplantation, cardiac surgery, otolaryngology, and surgical ethics. The team reviewed studies of the effect of COVID-19, as well as severe acute respiratory syndrome on hospital resources, health care providers, surgical procedures, and surgical patients in Asia and Europe and identified 21 factors related to outcome, risk of viral transmission to health care professionals, and use of resources.

Medically necessary time sensitive procedures: scoring system to ethically and efficiently manage resource scarcity and provider risk during the COVID-19 pandemic

Gastrointestinal Societies Offer Guidance on Endoscopy

Several gastrointestinal (GI) health care organizations released a guidance document April 13 on “Management of Endoscopes, Endoscope Reprocessing, and Storage Areas during the COVID-19 Pandemic.” The joint GI society document provides best practice recommendations on disinfection, handling, and storage and provides guidance for resumption of elective endoscopy.