Copyright © 2020 | COVID Frontline | All Rights Reserved | Website by Divigner

Patient Toolkit

The COVID FRONTLINE Patient Toolkit is a resource center for patients who have been diagnosed with or who are interested in learning about COVID-19. Choose from the options below to learn more.

Clinical Toolkit

The COVID-19 Clinical Toolkit is an online tool that aims to provide clinicians with up-to-date information on the presentation, prognosis, pathophysiology, and treatment strategies for COVID-19. Click on one of the options below to learn more.

This activity is provided by Med Learning Group. This activity is co-provided by Ultimate Medical Academy/CCM.
This activity is supported by educational grants from AbbVie, Astellas, Genentech, Lilly, Merck & Co., Inc., Pfizer and Regeneron Pharmaceuticals, Inc.

Copyright © 2019 | COVID Frontline | All Rights Reserved | Website by Divigner

Updates in the Treatment and Prevention of COVID-19​

Emergency use authorization for BNT162b2 for the prevention of COVID-19

BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine) is a messenger RNA (mRNA) vaccine delivered in a lipid nanoparticle to express the spike protein of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).1 On December 11, 2020, the US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for BNT162b2 for the prevention of coronavirus disease 2019 (COVID-19) in individuals 16 years of age and older.2, 3

Authorization is based on data from an ongoing phase 3 trial (NCT04368728), which showed that BNT162b2 was 95% effective in preventing symptomatic COVID-19 infections.1 With a median follow-up of 2 months after vaccination, there were 170 COVID-19 cases among study participants (8/21,720 in the vaccine group versus 162/21,728 in the placebo group) reported at or after 7 days following the second dose. Similar vaccine efficacy was reported across subgroups defined by age, sex, race, ethnicity, BMI, and coexisting conditions. Nine of the 10 severe COVID-19 cases reported in the trial occurred in the placebo group. The safety profile of BNT162b2 was characterized by local and systemic reactions (pain at the injection site, fatigue, headache, fever, chills), which were mostly short-term and mild-to-moderate. Reactions were relatively more common after the second dose in younger participants. Rare cases of anaphylaxis and Bell’s palsy were also reported in the trial.

Emergency use authorization for mRNA-1273 for the prevention of COVID-19

mRNA-1273 (Moderna COVID-19 Vaccine) is an mRNA vaccine delivered in a lipid nanoparticle to express the spike protein of SARS-CoV-2.4 On December 18, 2020, the FDA granted an EUA for mRNA-1273 for the prevention of COVID-19 in individuals 18 years of age and older.5, 6

Authorization is based on data from an ongoing phase 3 trial (NCT04470427), which showed that mRNA-1273 was 94.1% effective in preventing symptomatic COVID-19 infections.4 With a median follow-up of 2 months after vaccination, there were 196 COVID-19 cases among study participants (11/15,210 in the vaccine group versus 185/15,210 in the placebo group) reported at or after 14 days following the second dose. Vaccine efficacy was similar across key secondary subgroup analyses. All 30 severe COVID-19 cases reported in the trial (including 1 fatality) occurred in the placebo group. Mild-to-moderate, transient local and systemic reactions (pain at the injection site, fatigue, headache, myalgia, arthralgia) after vaccination were reported. Reactions were relatively more common after the second dose in younger participants. Rare cases of anaphylaxis and Bell’s palsy were also reported after vaccination.

Emergency use authorization for bamlanivimab for outpatients with mild-to-moderate COVID-19

Bamlanivimab (also known as LY-CoV555 and LY3819253) is a neutralizing monoclonal antibody against the spike protein of SARS-CoV-2.7 On November 9, 2020, the FDA granted an EUA for bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients (≥12 years of age and ≥40 kg) who test positive for SARS-CoV-2 and are at high risk for progressing to severe COVID-19 and/or hospitalization.8 High risk is defined as patients who are ≥65 years of age or have certain chronic medical conditions. Treatment with bamlanivimab should be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset.9 Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.8

Authorization is based on data from the ongoing phase 2/3 BLAZE-1 trial (NCT04427501) in which nonhospitalized participants with recently diagnosed mild or moderate COVID-19 were randomly assigned to receive placebo or bamlanivimab.7 Compared with placebo, treatment with bamlanivimab was associated with a reduction in SARS-CoV-2 viral load at day 11. Furthermore, the percentage of participants who had a COVID-19-related hospitalization or visit to an emergency department within 28 days was lower in the bamlanivimab group compared to the placebo group (1.6% versus 6.3%). Nausea and infusion-related reactions to bamlanivimab were reported but were generally uncommon.9

Emergency use authorization for bamlanivimab plus etesevimab for outpatients with mild-to-moderate COVID-19

Bamlanivimab (LY3819253 or LY-CoV555) and etesevimab (LY3832479 or LY-CoV016) are neutralizing monoclonal antibodies that bind to different epitopes of the spike protein of SARS-CoV-2.10 On February 09, 2021, the FDA granted an EUA for bamlanivimab plus etesevimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients (≥12 years of age and ≥40 kg) who test positive for SARS-CoV-2 and are at high risk for progressing to severe COVID-19 and/or hospitalization.11 High risk is defined as patients who are ≥65 years of age or have certain chronic medical conditions. Treatment with bamlanivimab plus etesevimab should be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset.12 Bamlanivimab and etesevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.11

Authorization is based on data from the ongoing phase 2/3 BLAZE-1 (NCT04427501) and phase 2 BLAZE-4 (NCT04634409) trials.10-12 Among nonhospitalized adults with mild-to-moderate COVID-19 who were at high risk for progressing to severe COVID-19, hospitalization or death occurred in 7% of participants who received placebo compared to 2% of those who received bamlanivimab plus etesevimab.11 All-cause death was also significantly lower in the bamlanivimab plus etesevimab group compared to the placebo group. Possible adverse effects of bamlanivimab plus etesevimab include nausea, dizziness, pruritus, and rash.

Emergency use authorization for casirivimab plus imdevimab for outpatients with mild-to-moderate COVID-19

Casirivimab (REGN10933) and imdevimab (REGN10987) are neutralizing monoclonal antibodies that bind to different epitopes of the spike protein of SARS-CoV-2.13 The combination of casirivimab and imdevimab (previously known as REGN-COV2) has been authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (≥12 years of age and ≥40 kg) who are at high risk for progressing to severe COVID-19 or hospitalization.14 High risk is defined as patients who are ≥65 years of age or have certain chronic medical conditions. Treatment with casirivimab plus imdevimab should be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset. Casirivimab plus imdevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.14

Interim results from 275 nonhospitalized patients in a placebo-controlled trial (NCT04425629) of casirivimab plus imdevimab found that the combination therapy reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Patients who received casirivimab plus imdevimab required fewer medical visits for COVID-19 than patients who received placebo (3% vs 6%, respectively). Among patients who were serum antibody-negative at baseline, 15% in the placebo group and 6% in the treatment group required COVID-19-related medical care.13 Infrequent infusion-related reactions to treatment with casirivimab plus imdevimab were reported.14

Baricitinib in combination with remdesivir authorized for emergency use in hospitalized patients with COVID-19

Baricitinib is an oral Janus kinase (JAK) inhibitor with anti-inflammatory as well as potential antiviral activity.15 Baricitinib, in combination with remdesivir, is authorized for emergency use in adult and pediatric patients ≥2 years of age hospitalized for COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).16

A recent trial (NCT04401579) of 1033 patients hospitalized for COVID-19 found that baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time (7 days vs 8 days, respectively; P= .03). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination therapy and 18 days with the control (rate ratio for recovery, 1.51). The addition of baricitinib to remdesivir was associated with 30% higher odds of improvement in clinical status at day 15 compared with remdesivir alone.15 Known adverse effects of baricitinib include serious venous thrombosis, such as pulmonary embolism, and serious infections.16

 

References 

  1. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603-2615.
  2. FDA. Pfizer-BioNTech COVID-19 Vaccine. Available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine. Accessed 2/10/2021.
  3. FDA. Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Fact Sheet for Healthcare Providers Administering Vaccine. Available at https://www.fda.gov/media/144413/download. Accessed 2/10/2021.
  4. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-416.
  5. FDA. FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine. Available at https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid. Accessed 2/10/2021.
  6. FDA. Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Factsheet for Healthcare Providers Administering Vaccine. Available at https://www.fda.gov/media/144637/download?utm_medium=email&utm_source=govdelivery. Accessed 2/10/2021.
  7. Chen P, Nirula A, Heller B, et al. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19. N Engl J Med. 2021;384(3):229-237.
  8. FDA. Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19. Available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19?utm_medium=email&utm_source=govdelivery. Accessed 2/10/2021.
  9. FDA. Emergency Use Authorization (EUA) of Bamlanivimab. Fact Sheet for Healthcare Providers. Available at https://www.fda.gov/media/143603/download. Accessed 2/10/2021.
  10. Gottlieb RL, Nirula A, Chen P, 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;e210202.
  11. FDA. Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19. Available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0. Accessed 2/10/2021.
  12. FDA. Emergency Use Authorization (EUA) of Bamlanivimab and Etesevimab. Fact Sheet for Healthcare Providers. Available at https://www.fda.gov/media/145802/download. Accessed 2/10/2021.
  13. Weinreich DM, Sivapalasingam S, Norton T, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19. N Engl J Med. 2021;384(3):238-251.
  14. FDA. Emergency Use Authorization (EUA) of Casirivimab and Imdevimab. Fact Sheet for Health Care Providers. Available at https://www.fda.gov/media/143892/download. Accessed 12/23/2020.
  15. Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus remdesivir for hospitalized adults with Covid-19. N Engl J Med. 2020;NEJMoa2031994.
  16. Emergency Use Authorization (EUA) of Baricitinib. Fact Sheet for Healthcare Providers. Available at https://www.fda.gov/media/143823/download. Accessed 12/23/2020.

Copyright © 2020 | COVID Frontline | All Rights Reserved | Website by Divigner

Patient Toolkit

The COVID FRONTLINE Patient Toolkit is a resource center for patients who have been diagnosed with or who are interested in learning about COVID-19. Choose from the options below to learn more.

Clinical Toolkit

The COVID-19 Clinical Toolkit is an online tool that aims to provide clinicians with up-to-date information on the presentation, prognosis, pathophysiology, and treatment strategies for COVID-19. Click on one of the options below to learn more.

This activity is provided by Med Learning Group. This activity is co-provided by Ultimate Medical Academy/CCM.
This activity is supported by educational grants from AbbVie, Astellas, Genentech, Merck & Co., Inc., and Pfizer.

Copyright © 2019 | COVID Frontline | All Rights Reserved | Website by Divigner