SARS CoV-2: Rising to the Testing Challenge in the United States Speakers: Supported by: Steven E. Cagas, PhD M. Laura Parnas, PhD, DABCC, FAACC
SA RS CoV - 2 : R i s i n g t o t h e Te s t i n g C h a l l e n g e i n t h e U n i t e d S t a t e s Steven E. Cagas, PhD M. Laura Parnas, PhD, DABCC, FAACC Medical and Scientific Affairs Roche Diagnostics April 29, 2020 2
Disclosures Dr. Cagas and Dr. Parnas are employees of Roche Diagnostics Corporation functioning as a Scientific Affairs Managers within the non-commercial division of Medical & Scientific Affairs. Data presented is intended for educational use to provide the participant with scientific, evidence-based information in compliance with FDA guidelines. All trademarks, trade names, images, or logos mentioned or used herein are the property of their respective owners and are not used for purposes of promotion or as an indication of affiliation with the provider of any particular good or service. 3 Information presented herein is current as of April 18, 2020.
Agenda • Background • Epidemiology • Tracking SARS-CoV-2 and COVID-19 • Testing Modalities • Testing Hurdles • Biomarkers and Serology • Potential Therapeutic Approaches • Questions and Answers
SARS-CoV-2: A Novel Coronavirus History The Virus • • World Health Organization (WHO) informed of A novel coronavirus ( SARS-CoV-2 ) was officially cases of pneumonia of unknown origin in Wuhan announced as the causative agent by Chinese City, Hubei Province, on 31-Dec-2019 . authorities on 07-Jan-2020 . • • WHO declares coronavirus a global emergency on The resulting disease has been named COVID-19 . 31-Jan-2020. 1.World Health Organization (WHO). Coronavirus. Geneva: WHO; 2020 Available from: [Accessed 26 Jan 2020]. 2.World Health Organization (WHO). Coronavirus Disease Outbreak: [Accessed 26 Jan 2020]. 5 3.Novel Coronavirus(2019-nCoV) Situation Report – 7. Available from: [Accessed 26 Jan 2020]. 4.Lu R, Zhao X, Li J, et al. Genomic characterization and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding ]The Lancet. Published online January 29
What are Coronaviruses? • Coronaviruses are large (HBV – 3kbp; CoV – 30 kb), enveloped RNA viruses • Coronaviruses are zoonotic, meaning they are transmitted between animals and people. • Animal reservoirs are ecologically diverse with the widest variety seen in bats , which are the reservoirs for many of these viruses . • Mammals may serve as intermediate hosts , facilitating recombination and mutation events with expansion of genetic diversity. • Not all coronaviruses are pandemic strains - endemic human coronavirus are responsible for approximately 5–10% of all upper and lower respiratory tract infections . • Two previous outbreaks: – Severe acute respiratory syndrome - SARS-CoV (2002) - China – Middle East respiratory syndrome - MERS-CoV (2012) - Saudi Arabia 1.Peiris, J., Guan, Y. & Yuen, K. Severe acute respiratory syndrome. Nat Med 10, S88–S97 (2004). https://doi.org/10.1038/nm1143 6
SARS* and MERS** - Brief History SARS-CoV MERS-CoV Focus of Outbreak China (2002) Saudi Arabia (2012), South Korea (2015) Animal source of human infection Civet cats Camels Infected people 8000 2494 % severe cases/mechanical ventilation 35 % 50-89% Deaths (mortality rate) 774 (<10%) 858 (34%) Distribution 29 countries 27 countries Global economy costs 30-120 billion (USD) 30-100 billion (USD) *SARS - Severe acute respiratory syndrome **MERS – Middle East respiratory syndrome 1. Center for Disease and Control Prevention. Evaluating and testing persons for Coronavirus disease 2019(COVID-19). (March 24, 2020).Retrieved from: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical- criteria.html?fbclid=IwAR30Pu8d3PT6vAR90E8xu93WryY5F5EIpSaJm6dAFcBAuHhdXi2K52SLGpw.Accesed on March 26, 2020. 2. Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) 7 Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA (2020).doi:10.1001/jama.2020.2648 3. Burrell C, Howard C & Murphy F. Chapter 31 – Coronavirus. In: Fenner and White’s Medical Virology. (2017) 437-446.
SARS-CoV-2: Relationship between SARS-CoV and SARS-CoV-2 • In December 2019, a cluster of pneumonia cases related to exposure to a live animal market emerged in Wuhan City, China. • Viral genome sequences identified novel coronavirus as causative agent ( originally named 2019-nCoV ) • On February 11, 2020, the World Health Organization (WHO) announced the official name of the novel coronavirus, SARS-CoV-2 , and the official name of the respiratory disease caused by the virus, COVID-19 . 1. Xu Y. Unveiling the Origin and Transmission of 2019-nCoV.Trends Microbiol. (2020)Apr;28(4):239-240.doi: 10.1016/j.tim.2020.02.001. 8
COVID-19 Signs and Symptoms Symptoms Fever, respiratory symptoms, abdominal pain, diarrhea, vomiting, headache, myalgia Clinical presentation Asymptomatic infection, mild illness, or fatal disease Transmission SARS-CoV-2 Person-to-person via respiratory secretions Incubation Range of 2-14 days (median – 5 days) Clinical progression Can cause severe respiratory disease 1 Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395:507-13. PMID: 32007143. 2. Holshue ML, DeBolt C, Lindquist S, et al. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020. PMID: 32004427. 3. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497-506. PMID: 31986264. 4. Wang D, Hu B, Hu C, 9 et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020. PMID: 32031570. 5. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19)–Evaluating and Reporting Persons Under Investigation (PUI). Accessed March 4, 2020. 6. Joseph T Wu*, Kathy Leung*, Gabriel M Leung, Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study Lancet 2020.
Clinical Classification of COVID-19 The Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th Edition) • Children meet any of the following criteria: Mild • The clinical symptoms are mild, and there was no sign of • Shortness of breath (<2 months old, RR ≥60 beats/min; 2 to pneumonia on chest imaging 12 months old, RR ≥50 beats/min; 1 to 5 years old, RR ≥40 beats/min; >5 years old, RR ≥30 beats/min), excluding Moderate the effects of fever and crying • These patients had fever and respiratory symptoms. • Oxygen saturation is ≤92% in the resting state Radiologic assessments found signs of pneumonia. • Assisted breathing (groaning, wing flaps, tri-retraction sign), Severe cyanosis, intermittent apnea • Adults meet any of the following criteria: • Lethargy and convulsions • Shortness of breath, RR ≥30 times/min • Refuse to feed, and have signs of dehydration • Oxygen saturation ≤93% at rest Critically Severe • Alveolar PaO 2 / FiO 2 ≤300 mmHg (1 mmHg = 0.133 • Patients meet any of the following conditions: kPa).* Patients whose pulmonary imaging showed • Respiratory failure requiring mechanical ventilation significant progression of lesion >50% within 24–48 hours should be treated as severe • Shock • Patients combined with other organ failure needed ICU monitoring and treatment * At high altitudes (>1000 m), PaO 2 / FiO 2 should be corrected according to the following formula: PaO 2 / FiO 2 x [Atmospheric pressure (mmHg)/760]. PaO 2 / FiO 2 , oxygen partial pressure / fraction of inspiration O 2.. The Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7 th Edition) http://kjfy.meetingchina.org/msite/news/show/cn/3337.html 10
COVID-19 Global Cases 27 January 2020 Source: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 (Accessed 01/27/20) 11
COVID-19 Global Cases 23 February 2020 https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 Accessed 02/23/20 12
COVID-19 Global Cases 18 April 2020 https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 (Accessed 04/18/20) 13
COVID-19 Global Cases 18 April 2020 https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 (Accessed 04/18/20) 14
Other Resources https://covid19.healthdata.org/united-states-of-america(Accessed 04/18/20) https://nextstrain.org/ncov/global (Accessed 4/18/20) 15
Other Resources https://usafacts.org/visualizations/coronavirus-covid-19-spread-map/(Accessed 04/18/20) https://www.google.com/covid19/mobility/(Accessed 4/18/20) 16
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