Clinical Toolkit

  • The most common signs and symptoms of COVID-19 are fever, cough, and shortness of breath. Less common symptoms include nausea, muscle ache, confusion, headache, and sore throat.

  • Pre-existing comorbid conditions that increase the likelihood of severe illness with COVID-19 include cardiovascular disease, diabetes, chronic respiratory disease, hypertension, cancer, and obesity.

  • It is estimated that roughly 15% of people infected with the new coronavirus will develop severe disease requiring hospitalization, and another 5% will become critically ill.

Clinical Care Toolkit Introduction

COVID-19 has created unprecedented challenges for the health care community worldwide. Recently, the emergence of novel therapeutic agents and vaccines against COVID-19 has significantly improved patient outcomes and reduced the number of individuals infected with SARS-CoV-2. In order to best serve patients, clinicians require up-to-date resources on how to utilize new therapies and the latest on changes to treatment recommendations. This Clinical Care Toolkit aims to provide health care providers with the most recent information on monoclonal antibodies, vaccines, and other agents for the treatment and prevention of COVID-19.

Click on the links below to begin exploring the COVID FRONTLINE initiative.

References

  1. Centers for Disease Control and Prevention (CDC). Learn About Age-Related Macular Degeneration. https://www.cdc.gov/features/healthyvisionmonth/index.html. Accessed March 6, 2020.
  2. Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. Lancet. 2018;392(10153):1147-1159.
  3. American Macular Degeneration Foundation [AMDF website]. Wet Macular Degeneration. https://www.macular.org/wet-amd. Accessed March 6, 2020.
  4. Fine AM. Earliest symptoms caused by neovascular membranes in the macular. Arch Ophthal. 1986;104:513-514.
  5. National Institutes of Health (NIH)/National Eye Institute (NEI). AMD Data and Statistics. https://www.nei.nih.gov/learn-about-eye-health/resources-for-health-educators/eye-health-data-and-statistics/age-related-macular-degeneration-amd-data-and-statistics. Accessed April 1, 2020.
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Updates in the Treatment and Prevention of COVID-19​

Bebtelovimab Is the Only Monoclonal Antibody That Retains Activity Against Omicron Subvariants

The Omicron subvariants BA.2 and BA.2.12.1 now account for 99% of all COVID-19 cases in the United States. Studies assessing the neutralizing activity of monoclonal antibodies for the treatment of COVID-19 have found that only bebtelovimab retains activity against BA.2 and BA.2.12.1. Other monoclonal antibodies, including sotrovimab, bamlanivimab, etesevimab, casirivimab, and imdevimab, are not effective against these new subvariants and are not currently authorized by the US Food and Drug Administration (FDA) to treat COVID-19 due to the high incidence of Omicron BA.2.

Bebtelovimab is authorized for emergency use by the FDA for the treatment of mild-to-moderate COVID-19 in patients 12 years and older weighing at least 40 kg with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death. Bebtelovimab should be administered as soon as possible after positive SARS-CoV-2 results and within 7 days of symptom onset.

FDA Approves Baricitinib for Hospitalized COVID-19 Patients

Baricitinib, an oral Janus kinase (JAK) inhibitor, is now FDA-approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). It is also authorized for emergency use by the FDA for hospitalized pediatric patients between 2 and 18 years of age who require oxygen support. The approval of baricitinib is based on efficacy and safety data from the ACTT-2 and COV-BARRIER clinical trials. In ACTT-2, baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time, particularly in patients receiving high-flow oxygen or noninvasive ventilation (10 days vs 18 days; rate ratio for recovery, 1.51; 95% confidence interval (CI), 1.10 to 2.08). The 28-day mortality was 5.1% with baricitinib plus remdesivir and 7.8% with remdesivir alone (hazard ratio [HR] for death, 0.65; 95% CI, 0.39 to 1.09). The COV-BARRIER trial found that baricitinib, in addition to standard of care (SoC), was associated with reduced 28-day mortality in hospitalized adults with COVID-19 compared with SoC alone (8% vs 13%; HR, 0.57; 95% CI, 0.41 to 0.78; P= .0018). The 60-day all-cause mortality was 10% with baricitinib plus SoC versus 15% with SoC (P= .005).

References:
Baricitinib fact sheet for healthcare providers. May 2022. (https://www.fda.gov/media/143823/download).  Accessed 5.24.2022.

Baricitinib (Olumiant®) PI 2022 (https://pi.lilly.com/us/olumiant-uspi.pdf). Accessed 5.24.2022.

Bebtelovimab fact sheet for healthcare providers. May 2022. (https://www.fda.gov/media/156152/download).  Accessed 5.24.2022.

Centers for Disease Control and Prevention (CDC). COVID data tracker. May 23, 2022. (https://covid.cdc.gov/covid-data-tracker/#variant-proportions). Accessed 5.24.2022.

Iketani S, et al. Antibody evasion properties of SARS-CoV-2 Omicron sublineages. Nature. 2022;604:553-556.

Kalil AC, et al. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med. 2021;384:795-807.

Marconi VC, et al. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. Lancet Resp Med. 2021;9:1407-1418.