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.
Menu

Updates in the Treatment and Prevention of COVID-19​

EUA of Bamlanivimab Plus Etesevimab Expanded to Include Younger Pediatric Patients

The emergency use authorization (EUA) for bamlanivimab plus etesevimab now includes an indication for treatment and post-exposure prophylaxis for children and newborn babies who are at high risk for severe disease. The expansion of the EUA is supported by a trial of 125 pediatric patients with at least one risk factor for severe illness; the study had safety and efficacy data similar to findings for adolescents and adults.

For more information visit www.fda.gov/news-events/press-announcements/fda-expands-authorization-two-monoclonal-antibodies-treatment-and-post-exposure-prevention-covid-19

 

Oral Antiviral Therapies With Emergency Use Authorization (EUA) for COVID-19

Two new oral antiviral therapies received emergency use authorization (EUA) for COVID-19: Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) and molnupiravir. Both therapies are authorized for the treatment of mild-to-moderate COVID-19 in certain people who are at high risk of progressing to severe illness.

In the EPIC-HR clinical trial, nirmatrelvir/ritonavir significantly reduced the risk of hospitalization or death from any cause by 88% compared with placebo. This treatment is indicated for adults and pediatric patients, 12 years of age and older who weigh at least 40 kilograms. Side effects include an impaired sense of taste, diarrhea, high blood pressure, and muscle aches. The safety and effectiveness of this combination therapy continue to be evaluated.

The main outcome measure of the MOVe-OUT trial of molnupiravir was the percentage of people who were hospitalized or died due to any cause during 29 days of follow-up. Compared with 9.7% of people who received placebo, 6.8% of those in the molnupiravir group were hospitalized or died. One person who received molnupiravir died versus nine people in the placebo group. Molnupiravir is not recommended for pregnant women or for those people younger than 18 years of age because of its effect on bone and cartilage growth.

For more information regarding the EUA for these oral antivirals, visit the following FDA URLs:

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

 

FDA Authorized Emergency Use Authorization (EUA) for Long-Acting Monoclonal Antibodies as Pre-Exposure Prophylaxis of COVID-19

Evusheld (tixagevimab co-packaged with cilgavimab and administered together) has been granted EUA for the prevention of COVID-19 in certain people with compromised immune systems or with a history of severe adverse reactions to a COVID-19 vaccine or any of its components. This combination is not meant to be a substitute for vaccination for those who have no contraindications to a COVID-19 vaccine.

The PROVENT clinical trial demonstrated a 77% reduction in the risk of developing COVID-19 compared with placebo, and protection appears to have been maintained through six months. Safety and efficacy of the tixagevimab/cilgavimab combination continues to be investigated.

For more information, visit www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure