The INMI experience for the Ebola response in Africa and in Europe and patients management

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1 The INMI experience for the Ebola response in Africa and in Europe and patients management Giuseppe Ippolito on behalf of INMI s VHFs response team National Institute for Infectious Diseases Lazzaro Spallanzani-Rome-Italy giuseppe.ippolito@inmi.it WHO Collaborating Center for clinical care, diagnosis, response and training on Highly Infectious Diseases

2 Ethical issues the INMI s Institutional Ethical Board (IEB) assessed the criteria for access to experimental drugs and invasive procedures, approved informed consent form. the patient signed an informed consent for any single procedure or treatment performed the Italian Drug Agency (AIFA) issued Emergency Use Authorization for investigational new drugs

3 Key point of the management virological monitoring on a large set of different biological specimen (urine, blood, stools, respiratory secretion) which made it possible to document the Ebola kinetics in different body compartments; the use experimental therapy; daily determination of EBOV RNA concentration in blood to describe potential temporal association between drugs administration and change in viremia levels; close monitoring of blood counts and clinicalchemistry.

4 First Patient: Ebola RNA in lung secretions documentation of interstitial pneumonia by X- rays with detection of Ebola RNA from unconcentrated lung secretion more than 100 times higher than in concomitant plasma sample;

5 First patient: treatments Favipiravir Convalescent plasma ZMAb Melanocortin

6 Second patient documentation of interstitial pneumonia by X- rays with detection of Ebola RNA from sputum

7 First patient: treatments Favipiravir Mill 77

8 Members of the INMI s VHFs Team Crisis unit 21

9 Members of the INMI s EBOV Team=61 Infectious Diseases Physicians 11 Intensive Care Physicians 5 Nurses 14 Radiologists 1 Hospital pharmacist 1 Virologists and microbiologists 23 Electronic Microscopists 2 Drivers biocontainment ambulance 2 Engineers 2 Press Office 5 Logistician 1

10 Pathway towards the establishment of INMI as a model of response to emerging IDs Key words: Research Diagnosis Prevention Care Ntl Referral Center for Bioterrorism Approval of an High Isolation Facility, new BSL4, 3 BSL3 labs and a biocontainment cryobank Concept proposed for 1 BSL4 and 2 BSL3 lab WHO Collaborating Center for clinical care, diagnosis, response and training on Highly 2009 Infectious Diseases Coordination of EU Networks on BSL4, 2006 HIDs units, training in EIDs emergencies, harmonization Ntl Referral Center for Avian Flu New Clinical Center (200 beds at negative pressure) and a BSL3 Lab Ntl Referral Center for VHFs Isolation Unit for dangerous pathogens with Biocontainement Lab National Referral Center for Smallpox and dangerous IDs 1936 Opening IDs Center Infrastructure of Pan-European Interest identified by EC in the ESFRI on Highly Pathogenic Agents BSL4 and 2 BSL3 labs open Agreement with NIH-NIAID -BSL4-authorized -2 BSL3 and cryobank open -Ntl Referral Center for SARS -GOARN partner High Isolation Facility

11 Italian Institutions Acknowledgments Ministry of health of Italy Italian Air Force National Blood Center National Drug Agency- AIFA Customhouses Fiumicino and Malpensa The state police, the fire department and Carabinieri national military police The Italian Red Cross The Lazio Region

12 Acknowledgments International Institutions World Health Organization WHO-Geneva European Commission, DG Special Pathogens Program, Public Health Agency of Canada Infectious Diseases Royal Free London NHS Foundation Trust, London, United Kingdom Centers for Disease Control and Prevention, Atlanta, GA, USA Bernhard Nocht Institute for tropical medicine, Section Parasitology University Hospital Frankfurt, Frankfurt/Main, Germany. University Hospitals of Geneva, Switzerland, Intensive Care Hospital La Paz, Madrid, Spain Instituto de Salud Carlos III, Madrid, Spain (María Paz Sanchez-Seco, Pedro Anda) Agence Nationale de Sécurité du Médicament et des produits de santé-ansm EPRUS (French Establishment for the Preparation and Response to Health Emergencies), IHU Mediterranee Infection,Southern France Service de Maladies Infectieuses et tropicales, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Madrid-Spain (César Hernàndez Garcìa) Ministerio de Sanidad, Servicios Sociales e Igualdad, Madrid-Spain

13 Acknowledgments Industrial research, diagnostic, pharmaceutical and regulatory companies Altona Diagnostics GmbH. Hamburg, Germany Chimerix Ltd. Durham North Carolina- USA Optum- Regulatory Services, Life Sciences Orlando, Florida Toyama Chemical Co., Ltd./Fuji Chemical Industry Co., Ltd. Japan Medivector Boston, MA, USA Mapp Biopharmaceutical, Inc. San Diego, CA USA Health Ricerca e Sviluppo - HR&S, Massa Lombarda, RA, Italy MChE-F4Pharma, Vienna, Austria Accella Advisors GmbH, Uetliburg SG, Switzerland

14 The INMI s motto is: deeds not words.