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COVID and COVID Vaccine Update

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COVID and COVID Vaccine Update Friday General Session COVID and COVID Vaccine Update Jason Bowling, MD Associate Professor of Infectious Disease, Medical Director of Infection Control and Hospital Epidemiologist Company UT Health San Antonio San Antonio, Texas Educational Objectives By completing this educational activity, the participant should be better able to: 1. Evaluate the diagnostic challenges surrounding COVID. 2. Assess the risk factors for mild versus severe disease in patients infected with COVID. 3. Assess the rapidly changing treatment landscape for COVID patients with mild to moderate disease. Discuss the mechanism of action, side effects, and adverse events of COVID vaccines and review recommendations regarding COVID vaccination. Speaker Disclosure Dr. Bowling has disclosed that neither he nor members of his immediate family have a relevant financial relationship with an ineligible company. 6 COVID-19 and COVID-19 Vaccine Update Disclosures Jason Bowling, MD, FIDSA Associate Professor of Medicine Medical Director Infection Prevention UH & UTHSA Hospital Epidemiologist, University Hospital • I have no financial disclosures or conflicts of interest to report. • I will discuss medications being used in the context of a clinical trial. 12 Objectives • Analyze the clinical impact of the virology and epidemiology of COVID-19. • Evaluate the diagnostic challenges surrounding COVID-19. • Assess the rapidly changing treatment landscape for COVID-19 patients: outpatients and inpatients. • Discuss the mechanism of action, side effects, and adverse effects of COVID-19 vaccines and review recommendations regarding COVID-19 vaccination. https://coronavirus.jhu.edu/map.html - Accessed 5-19-21 34 San Antonio Metro Health: 5-19-21 56 1 Hospitalized COVID-19 Patients IHME COVID-19 PROJECTIONS: TEXAS University Hospital 5-19-21 COVID-19 (healthdata.org) – Updated 5/19/21 78 Brief SARS-CoV-2 Virology SARS-CoV-2 Pathogenesis • Spike protein binds ACE-2 receptor in human host • ACE-2 receptors . Respiratory tract epithelium - Oropharynx, upper airway . Blood vessel endothelium . GI tract, kidneys • Some proofreading during replication = less mutation than other RNA viruses BMJ 2020;371:m3862 BMJ 2020;371:m3862 910 Clinical Presentations of Influenza Question #1 and Other Respiratory Illnesses (continued) Influenza1 COVID‐19a2,3 Colds1 Allergiesb4 Signs/ Clinical diagnosis can readily distinguish COVID-19 from Symptoms Gradual onset, influenza infection. Abrupt onset, fever, Fever, dry cough, Rhinitis, sneezing, sneezing, sore aches, chills, fatigue, dyspnea, myalgia, sinus congestion, Common throat, stuffy nose, weakness, cough, fatigue, new loss of mild cough, mild to moderate headache taste or smell sore throat cough 1. True Pharyngitis, Less Sore throat, stuffy headache, GI upset, Fatigue, headache — common nose, GI upset 2. False productive cough Fever, dyspnea, Fever, dyspnea, Rare Dyspnea, sneezing — GI upset myalgia, GI upset aInformation evolving rapidly and subject to change bSeasonal GI, gastrointestinal 1. CDC. 12/30/19. www.cdc.gov/flu/symptoms/coldflu.htm. Accessed 8/17/20. 2. CDC. 8/4/20. www.cdc.gov/flu/symptoms/flu‐vs‐covid19.htm. Accessed 8/17/20. 3. Auwaerter PG. 5/23/20. www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ ABX_Guide/540747/all/Coronavirus_ COVID_19__SARS_CoV_2_. Accessed 8/17/20. 4. National Institute of Allergy and Infectious Diseases. www.niaid.nih.gov/ diseases‐conditions. Accessed 8/17/20. 13 11 13 2 Clinical Course of Influenza vs. COVID‐19 Natural History of COVID-19 Infection Influenza Clinical Course1,2 Fever, chills, fatigue, myalgia, Cough may persist >2 wk (eg, dry cough, sore Symptoms elderly, chronic lung disease) throat, headache, peak rhinitis 1 3 4 7 14+ Day Infectivity: 1 d before to 3‐4 d after symptom onset3 COVID‐19 Clinical Course2,4 Fever, cough, sore throat, new loss of taste/smell, Symptoms peak: ≈2‐4 wk headache, myalgias Recovery stage: ≈2‐8 wk 1 71410 21+ Day Remdesivir,Re Dexamethasone, Convalescent plasma, Monoclonal antibodies Infectivity (still under investigation): 2 d before to ≥10 d after symptom onset3 1. CDC. 3/8/19. www.cdc.gov/flu/professionals/acip/clinical.htm. Accessed 8/3/20. 2. Solomon DA et al. JAMA. 2020 Aug 14. [Epub ahead of print] 3. CDC. 7/27/20. www.cdc.gov/flu/symptoms/flu‐vs‐covid19.htm#anchor_1595599599www.cdc.gov/flu/about/disease/spread.htm. Accessed 8/3/20. 4. Subbarao K et al. Immunity 2020;52(6):905‐909. 14 14 15 Risk Factors for Severe COVID-19 Question #2 • Older age Mr. Jones is a 54 y/o male patient of yours who has had 2 days of acute • Chronic obstructive pulmonary disease fever, fatigue, loss of taste and smell, and a dry cough. His son returned home from college a week ago, was not feeling well, and tested positive for • Cardiovascular disease (e.g., heart failure, coronary artery disease, COVID-19. Mr. Jones went to an urgent care clinic near his house yesterday or cardiomyopathy) and had a rapid SARS-CoV-2 antigen test that was negative. He is now • Type 2 diabetes mellitus calling you for evaluation of his persistent symptoms. The best approach to • Obesity (BMI >= 30) establish his diagnosis would be to: • Sickle cell disease 1. Repeat the SARS-CoV-2 antigen test Chronic kidney disease • 2. Obtain a rapid test for influenza • Immunocompromised state from solid organ transplant 3. Perform a PCR test for SARS-CoV-2 • Cancer 4. Obtain an antibody test for SARS-CoV-2 5. Start doxycycline and see if he gets better N Engl J Med 2020;383:1757-66. 16 17 Direct Viral Tests for SARS-CoV-2 Nucleic acid amplification tests Antigen tests COVID-19 Diagnostic Tests (NAAT) • Various assays, PCR is most • Target nucleocapsid protein common • Less sensitive than PCR test • Many target 2 or more genes: . Can cause false negative . nucleocapsid, envelope, spike • Works best earlier in illness when • Highly sensitive and specific viral loads are higher • Require specialized lab • Faster turnaround time (15-30 min) • Turnaround in lab • Point-of-care • More expensive • Cheaper Image credit: www.nejm.org 19 20 3 SARS-CoV-2 Antigen vs PCR testing CDC Algorithm • CDC analysis of 2 community COVID testing sites • Compared Antigen vs PCR testing and viral culture • Sensitivity . Asymptomatic: 35.8% . Symptomatic: 64.2% • Specificity . 99.8-100% in both groups • Can be useful but BEWARE risk of false negative MMWR Jan 2021;70(3):100-150 21 22 Suggested Approach with Antigen Important Caveats • Use in symptomatic patients • Direct viral tests good for time of test – like Polaroid • Best if used within first few days of symptom onset • PCR tests can remain persistently positive for weeks • Negative test in high risk should have PCR test • Negative antigen tests should have f/u PCR test • Positive test in consistent clinical presentation is likely a • Neither category is affected by variants thus far true positive • Neither category detects variants • COVID-19 vaccination does not influence results of direct viral tests 23 24 Antibody Tests Question #3 • Detect both neutralizing and non-neutralizing antibodies Your patient Mr. Jones had a positive PCR test for COVID-19. His O2 saturation is 98% on room air and he doesn’t require hospitalization. You • Early in pandemic, EUA was voluntary are concerned about his risk of progression to more severe COVID-19 disease because he has a BMI of 42, DM2, and 3 vessel CAD. What • Some tests cross-react with common coronavirus would be the best treatment recommendation for him? • Not recommended for use in first 14 days after symptom onset (IDSA guidelines) 1. Monoclonal antibody therapy • Not indicated to determine response to vaccine 2. Hydroxychloroquine 3. Azithromycin 4. High dose dexamethasone 5. Hydroxychloroquine, azithromycin, and dexamethasone www.idsociety.org/COVID19guidelines/serology 25 26 4 COVID-19 Treatment • Majority of rigorous trial data for treatment has focused on hospitalized patients COVID-19 Treatment • Currently no oral FDA-approved or authorized therapies for COVID-19 Outpatient Management Strategies • NIH and IDSA guidelines do not recommend non-FDA approved therapies outside of a clinical trial 28 29 COVID-19 Treatment Outpatient Strategies • Majority of rigorous trial data for • General Recommendations • Isolation – Persons treatment has focused on • Nutrition/hydration diagnosed with COVID-19 hospitalized patients • Adequate sleep should isolate at home. • Currently no oral FDA-approved • Continue isolation for: or authorized therapies for • Stop/limit smoking and vaping . 10 days from symptom-onset COVID-19 AND • NIH and IDSA guidelines do not • Limit alcohol use . At least 24 hours afebrile recommend non-FDA approved • Acetaminophen or ibuprofen • Asymptomatic – 10 days therapies outside of a clinical trial for fever from first positive test Document available at www.strac.org (Southwest Texas Regional Advisory Council) 30 31 Outpatient Strategies Monoclonal Antibodies Equipment for home Warning Signs – SEEK CARE • FDA authorization under EUA: • Thermometer • Oxygen saturation <94% at rest . Bamlanivimab and etesevimab • Pulse oximeter • Significant desaturation into . Casirivimab and imdevimab • Home blood pressure cuff 85% range upon walking • Only available via IV infusion over 1 hour with post-monitoring • Persistent shortness of breath Possible side effects: infusion-related reactions such as fever, • Persistent fever • chills, flushing, hives, itching, anaphylaxis • Decrease in mental status • Significant decrease in blood pressure 32 33 5 Monoclonal Antibodies – Who? Not Recommended . Have had a positive direct viral test for SARS-CoV-2 . Corticosteroids – not in outpatients . Have had < 5 days of symptoms (up to 10 days) - RECOVERY trial showed benefit for those requiring . 12 years of age and older supplemental oxygen. Weigh at least 40 kilograms (about 88 pounds) - Pts who did not require oxygen had worse clinical outcomes . AND at high risk for progressing to severe COVID-19 and/or . Hydroxychloroquine hospitalization - Multiple well-conducted studies show negative results . Especially at risk: > 65 yo or BMI > 35 - Side effects – GI and prolonged QT interval www.covid19treatmentguidelines.nih.gov The Recovery Collaborative Group. Dexamethasone in Hospitalized Patients with Covid-19.
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