Additional Resources

New data regarding the prevention, diagnosis, and management of COVID-19 are emerging daily. Please see the list of COVID-19 resources for healthcare professionals provided below for additional up-to-date and comprehensive information.

Managing Patients with COVID-19

Factsheets for healthcare providers

Recommendations on the management of special populations during the COVID-19 pandemic.

New data regarding the prevention, diagnosis, and management of COVID-19 are emerging daily. Please see the list of COVID-19 resources for healthcare professionals provided below for additional up-to-date and comprehensive information.

Resources CDC, HHS, NIH, and WHO

US Department of Health and Human Services (HHS). Find ways to prevent, treat or help fight COVID-19. https://combatcovid.hhs.gov/

National Institutes of Health (NIH). COVID-19 Treatment Guidelines. https://covid19treatmentguidelines.nih.gov/introduction/

Centers for Disease Control and Prevention (CDC). Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html

CDC. Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html

NIH. COVID-19 Treatment Guidelines. https://covid19treatmentguidelines.nih.gov/introduction/

CDC. Information for Healthcare Professionals about Coronavirus (COVID-19). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html

World Health Organization (WHO). Country & Technical Guidance – Coronavirus disease (COVID-19). https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance

Additional Guidance on the Management of Patients with COVID-19.

Society of Critical Care Medicine. Surviving Sepsis Campaign: COVID-19 Guidelines. https://www.sccm.org/SurvivingSepsisCampaign/Guidelines/COVID-19

Infectious Disease Society of America (IDSA). COVID-19 Resource Center. https://www.idsociety.org/public-health/COVID-19-Resource-Center/

IDSA. Infectious Diseases Society of America Guidelines on Infection Prevention in Patients with Suspected or Known COVID-19. https://www.idsociety.org/practice-guideline/covid-19-guideline-infection-prevention/

Recommendations on the Management of Special Populations During the COVID-19 Pandemic.

Al-Shamsi HO, Alhazzani W, Alhuraiji A, et al. A practical approach to the management of cancer patients during the novel coronavirus disease 2019 (COVID-19) pandemic: an international collaborative group. Oncologist. 2020. https://doi.org/10.1634/theoncologist.2020-0213

American College of Surgeons (ACS). Recommendations for prioritization, treatment and triage of breast cancer patients during the COVID-19 pandemic. Available at https://www.facs.org/quality-programs/cancer/executive-summary

American Society of Clinical Oncology (ASCO). COVID-19 Patient Care Information. https://www.asco.org/asco-coronavirus-information/care-individuals-cancer-during-covid-19

Centers for Disease Control and Prevention (CDC). Considerations for Inpatient Obstetric Healthcare Settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/inpatient-obstetric-healthcare-guidance.html

American College of Obstetricians and Gynecologists (ACOG). Novel Coronavirus 2019 (COVID-19). https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/03/novel-coronavirus-2019

Supporting Patient Journeys Through Resources and Tools to Promote Positive Patient Outcomes in Care

National Infusion Center Association. COVID-19 Antibody Therapies Resource Center. https://infusioncenter.org/infusion_resources/covid-19-antibody-treatment-resource-center/

CombatCOVID.hhs.gov. Monoclonal Antibodies for High-Risk COVID-19 Positive Patients. https://combatcovid.hhs.gov/i-have-covid-19-now/monoclonal-antibodies-high-risk-covid-19-positive-patients?gclid=EAIaIQobChMI4r-5loX27gIVCaiGCh3AQgwgEAAYASAAEgI76fD_BwE

Joost Wiersinga W, et al. Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): A review. JAMA. 2020;10.1001/jama.2020.12839. https://pubmed.ncbi.nlm.nih.gov/32648899/

Guan WJ, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020;382:1708-1720. https://pubmed.ncbi.nlm.nih.gov/32109013/

Rothan HA, et al. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020;109:102433. https://pubmed.ncbi.nlm.nih.gov/32113704/

Lechien JR, et al. Clinical and epidemiological characteristics of 1420 European patients with mild-to-moderate coronavirus disease 2019. [published online ahead of print, 2020 Apr 30]. J Intern Med. 2020; 10.1111/joim.13089. https://pubmed.ncbi.nlm.nih.gov/32352202/

Wang W, et al. Updated understanding of the outbreak of 2019 novel coronavirus (2019-nCoV) in Wuhan, China. J Med Virol. 2020;92:441-447. https://pubmed.ncbi.nlm.nih.gov/31994742/

Wu Z, et al. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: Summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020;323:1239-1242. https://jamanetwork.com/journals/jama/fullarticle/2762130

Richardson S, et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area. JAMA. 2020 May 26;323:2052–2059. https://pubmed.ncbi.nlm.nih.gov/32320003/

Docherty AB, et al. Features of 20,133 UK patients in hospital with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol: Prospective observational cohort study. BMJ. 2020;369:m1985. https://www.bmj.com/content/369/bmj.m1985

Yuan X, et al. Changes of hematological and immunological parameters in COVID-19 patients. [published online ahead of print, 2020 Jul 12]. Int J Hematol. 2020;1-7. https://pubmed.ncbi.nlm.nih.gov/32656638/

Bhimraj A, et al. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. IDSA Guidelines. V2.1.0. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/

Alhazzani W, et al. Surviving Sepsis Campaign: Guidelines on the management of critically ill adults with coronavirus disease 2019 (COVID-19). Intensive Care Med. 2020;46:854-887. https://pubmed.ncbi.nlm.nih.gov/32222812/

World Health Organization (WHO). Clinical management of COVID-19. Interim Guidance. 2020 May 27. https://www.who.int/publications/i/item/clinical-management-of-covid-19

National Institutes of Health (NIH). COVID-19 Treatment Guidelines. https://www.covid19treatmentguidelines.nih.gov/

Beigel JH, et al. Remdesivir for the treatment of COVID-19 – Final Report. N Engl J Med. 2020;383:1813-1826. https://www.nejm.org/doi/full/10.1056/NEJMoa2007764

Spinner CD, et al. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. JAMA. 2020;324:1048-1057. https://jamanetwork.com/journals/jama/fullarticle/2769871

Horby P, et al. Dexamethasone in hospitalized patients with COVID-19 – preliminary report. N Engl J Med. 2020;Epub ahead of print. https://pubmed.ncbi.nlm.nih.gov/32678530/

Siddiqi HK, et al. COVID-19 illness in native and immunosuppressed states: A clinical-therapeutic staging proposal. J Heart Lung Transplant. 2020;39:405-407. https://www.jhltonline.org/article/S1053-2498(20)31473-X/fulltext

Li L, et al. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: A randomized clinical trial. [published online ahead of print, 2020 Jun 3].JAMA. 2020;e2010044. https://pubmed.ncbi.nlm.nih.gov/32492084/

Kalil AC, et al. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med. 2020;Epub ahead of print. https://www.nejm.org/doi/full/10.1056/NEJMoa2031994

Baum A, et al. Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies. Science. 2020;369:1014-1018. https://pubmed.ncbi.nlm.nih.gov/32540904/

Gandhi RT, et al. Mild or moderate COVID-19. N Engl J Med. 2020;383:1757-1766. https://pubmed.ncbi.nlm.nih.gov/32329974/

Docherty AB, et al. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020;369:m1985. https://pubmed.ncbi.nlm.nih.gov/32444460/

Simonovich VA, et al. A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. N Engl J Med. 2020;Epub ahead of print. https://pubmed.ncbi.nlm.nih.gov/33232588/

Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Baricitinib. https://www.fda.gov/media/143823/download

Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Bamlanivimab. http://pi.lilly.com/eua/bamlanivimab-eua-factsheet-hcp.pdf

Fact Sheet for Health Providers Emergency Use Authorization (EUA) of Bamlanivimab and Etesevimab. https://www.fda.gov/media/145802/download

Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Casirivimab and Imdevimab. https://www.fda.gov/media/143892/download

Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of COVID-19 Convalescent Plasma for Treatment of Hospitalized Patients with COVID-19. https://www.fda.gov/media/141478/download

Weinreich DM, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-29. N Engl J Med. 2020;Epub ahead of print. https://www.nejm.org/doi/pdf/10.1056/NEJMoa2035002

Gottlieb RL, et al. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2021;325:632-644. https://jamanetwork.com/journals/jama/fullarticle/2775647

Chen P, et al. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med. 2020;Epub ahead of print. https://www.nejm.org/doi/full/10.1056/NEJMoa2029849

ACTIV-3/TICO LY-CoV555 Study Group. A neutralizing monoclonal antibody for hospitalized patients with COVID-19. N Engl J Med. 2020;Epub ahead of print. https://www.nejm.org/doi/full/10.1056/NEJMoa2033130

Hansen J, et al. Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail. Science. 2020;369:1010-1014. https://science.sciencemag.org/content/369/6506/1010

Callaway E. The coronavirus is mutating – does it matter? Nature. 2020;585:174-177. https://www.nature.com/articles/d41586-020-02544-6

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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