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1. Clinical presentation, outcomes and factors associated with mortality: A prospective study from three COVID-19 referral care centres in West Africa

Author

Olivier Marcy, Denis Malvy, Flavien Kaboré, Augustin Augier, Mamadou Saliou Sow, Caroline Martin, Hans-Joerg Lang, Armel Poda, Sani Sayadi, Joseph Donamou, Adama Sanou, Billy Sivahera, Jean-Paul-Yassa Guilavogui, Fodé Bangaly Sako, Eudoxie Koumbem, Eric Arnaud Diendéré, Sylvain Juchet, Marie Jaspard, B. Serra, Moumouni Kinda, Brice Bicaba, Xavier Anglaret, Sakoba Keita, Fodé Amara Traoré, Richard Kojan, Apoline Sondo, Fanny Velardo, Halidou Tinto, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Donka University National Hospital [Guinée], The Alliance for International Medical Action [Dakar, Sénégal] (ONG ALIMA), Centre Hospitalier Universitaire Yalgado Ouédraogo (CHUYO), and Université Nazi Boni [Bobo-Dioulasso, Burkina Faso]

Subjects
Adult, Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Referral, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), SARS-Cov-2, 030106 microbiology, Disease, Infectious and parasitic diseases, RC109-216, West africa, Comorbidities, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Burkina Faso, Humans, Medicine, Prospective Studies, 030212 general & internal medicine, Mortality, Prospective cohort study, Referral and Consultation, Aged, Sub-Saharan Africa, business.industry, COVID-19, General Medicine, 3. Good health, Hospitalization, Infectious Diseases, Death toll, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Presentation (obstetrics), business
Abstract

International audience; OBJECTIVES: The overall death toll from COVID-19 in Africa is reported to be low but there is little individual-level evidence on the severity of the disease. This study examined the clinical spectrum and outcome of patients monitored in COVID-19 care centres (CCCs) in two West-African countries. METHODS: Burkina Faso and Guinea set up referral CCCs to hospitalise all symptomatic SARS-CoV-2 carriers, regardless of the severity of their symptoms. Data collected from hospitalised patients by November 2020 are presented. RESULT: A total of 1,805 patients (64% men, median age 41 years) were admitted with COVID-19. Symptoms lasted for a median of 7 days (IQR 4-11). During hospitalisation, 443 (25%) had a SpO2 < 94% at least once, 237 (13%) received oxygen and 266 (15%) took corticosteroids. Mortality was 5% overall, and 1%, 5% and 14% in patients aged

Published
2021

2. The OptiMA protocol in children with wasting and stunting - Authors' reply

Author

Renaud Becquet, Cécile Cazes, Kevin Phelan, Béatrice Kalenga Tshiala, Susan Shepherd, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Global Health in the Global South (GHiGS), Institut de Recherche pour le Développement (IRD)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Alliance for International medical Action (ALIMA), Ministry of Health, Kinshasa [Kinshasa, Democratic Republic of the Congo], The Alliance for International Medical Action [Dakar, Sénégal] (ONG ALIMA), and Admin, Oskar

Subjects
[SDV.AEN] Life Sciences [q-bio]/Food and Nutrition, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Wasting Syndrome, Prevalence, Humans, Infant, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, General Medicine, Child, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Growth Disorders
Abstract

International audience; No abstract available

Published
2022

3. Impact on disease mortality of clinical, biological, and virological characteristics at hospital admission and overtime in COVID‐19 patients

Author

Yazdanpanah, Yazdan, DIALLO, Alpha, PAUL, Christelle, MERCIER, Noémie, LE MESTRE, Soizic, PETROV‐SANCHEZ, Ventzislava, ANDREJAK, Claire, CHIROUZE, Catherine, MALVY, Denis, DEPLANQUE, Dominique, DUBOS, François, ROSSIGNOL, Patrick, ETIENNE, Manuel, ROSSIGNOL, Bénédicte, LEVY‐MARCHAL, Claire, GILG, Morgane, GIGANTE, Tristan, Marine, BELUZE, HULOT, Jean‐Sebastien, CHAIR, Anissa, KHALIL, Antoine, VISSEAUX, Benoit, COUFFIGNAL, Camille, ROY, Carine, LAOUÉNAN, Cédric, DA SILVEIRA, Charlene, TARDIVON, Coralie, BACHELET, Delphine, DESCAMPS, Diane, MENTRÉ, France, BOMPART, François, LESCURE, François‐Xavier, PEYTAVIN, Gilles, GORENNE, Isabelle, HOFFMANN, Isabelle, GHOSN, Jade, Christophe LUCET, Jean, TIMSIT, Jean‐François, MULLAERT, Jimmy, BHAVSAR, Krishna, BOUADMA, Lila, TAGHERSET, Lysa, TELLIER, Marie‐Capucine, DEBRAY, Marie‐Pierre, ESPOSITO‐FARESE, Marina, SCHNEIDER, Marion, LE, Minh, ETTALHAOUI, Nadia, SI MOHAMMED, Nassima, GAULT, Nathalie, PEIFFER‐SMADJA, Nathan, KEFIF, Ouifiya, ELOY, Philippine, LE HINGRAT, Quentin, KALI, Sabrina, LARIBI, Samira, TUBIANA, Sarah, TRIOUX, Théo, DUVAL, Xavier, VANEL, Noémie, PICONE, Olivier, BASMACI, Romain, ANGOULVANT, François, KAGUELIDOU, Florentia, PAGES, Justine, VEISLINGER, Aurélie, TUAL, Christelle, PAPADOPOULOS, Aurélie, ESPEROU, Hélène, JAAFOURA, Salma, COUFFIN‐CADIERGUES, Sandrine, COELHO, Alexandra, HOCTIN, Alexandre, DIOUF, Alphonsine, MAMBERT, Marina, GAYMARD, Alexandre, LINA, Bruno, ROSA‐CALATRAVA, Manuel, BOUSCAMBERT, Maude, TERRIER, Olivier, MEZIANE, Amina, DORIVAL, Céline, BENKEROU, Dehbia, TÉOULÉ, François, LINGAS, Guillaume, LE NAGARD, Hervé, GUEDJ, Jérémie, NEANT, Nadège, ABEL, Laurent, KHAN, Coralie, DESVALLÉE, Mathilde, WIEDEMANN, Aurélie, LEVY, Yves, MOUQUET, Hugo, BEHILILL, Sylvie, van der WERF, Sylvie, ENOUF, Vincent, SEMAILLE, Caroline, dORTENZIO, Eric, CERVANTES‐GONZALEZ, Minerva, PUÉCHAL, Oriane, NORET, Marion, RORIZ, Mélanie, RISPAL, Patrick, REDL, Sarah, LEFEBVRE, Laurent, GRANIER, Pascal, MAULIN, Laurence, JOSEPH, Cédric, MOYET, Julien, LION‐DAOLIO, Sylvie, MAHIEU, Rafael, DUCANCELLE, Alexandra, DUBEE, Vincent, SALLABERRY, Stéphane, MANUEL, Aldric, MACHEDA, Gabriel, MAILLET, Mylène, CHANZY, Bruno, GAGNARD, Jean‐Charles, GIORDANO, Guillermo, MOUTON PERROT, Clara, PESTRE, Vincent, FICKO, Cécile, GOMINET, Marie, BOUSQUET, Aurore, VAUCHY, Charline, BOUILLER, Kévin, PAGADOY, Maïder, MARTY‐QUINTERNET, Solène, LEPILLER, Quentin, LE BRIS, Cyril, THILL, Benoit, CASANOVA, Marie‐Laure, LE FALHER, Georges, OZIOL, Eric, CORDEL, Hugues, DOURNON, Nathalie, BOUCHAUD, Olivier, BRICHLER, Ségolène, NGUYEN, Duc, BELLECAVE, Pantxika, CICCONE, Camille, LAFON, Marie‐Edith, GREFFE, Ségolène, BOUISSE, Camille, SEDILLOT, Nicholas, BOUHOUR, Damien, CHASSIN, Camille, LHER, Erwan, ANSART, Séverine, TROMEUR, Cécile, GUELLEC, Dewi, MERCKX, Antoine, DJOSSOU, Felix, PEIGNE, Vincent, PIEROBON, Carola, CARRET, Marie‐Christine, JEGO, Florence, ISNARD, Margaux, AUCHABIE, Johann, COURTOIS, Roxane, LESENS, Olivier, MARTINOT, Martin, LACOSTE, Marie, ELHARRAR, Brigitte, GARRAIT, Valérie, DELACROIX, Isabelle, MAITRE, Thomas, Baptiste ASSIE, Jean, NYAMANKOLLY, Elsa, Xavier CATHERINE, François, BLOT, Mathieu, MAHY, Sophie, BUISSON, Marielle, PIROTH, Lionel, GUILLOTIN, Florence, DE ROUGEMONT, Alexis, CAMPANA, Valentine, PASQUIER, Jérémie, CABIE, André, BESSIS, Simon, EPAULARD, Olivier, TERZI, Nicolas, PAYEN, Jean‐François, BOUILLET, Laurence, HAMIDFAR, Rebecca, Le MARECHAL, Marion, MACHADO, Moïse, BARRELET, Audrey, BEDOSSA, Alexandra, COLIN, Gwenhaël, DECOURS, Romain, GUIMARD, Thomas, GOUJARD, Cécile, JAUREGUIBERRY, Stéphane, CHERET, Antoine, Sophie RESSEGUIER, Anne, POISSY, Julien, MATHIEU, Daniel, NSEIR, Saad, ENGELMANN, Ilka, REMY, Martine, VUOTTO, Fanny, GACHET, Benoit, FAURE, Karine, BOYER‐BESSEYRE, Marielle, Enagnon, Kazali, LAMBERT, Marc, SCHERPEREEL, Arnaud, FRY, Stéphanie, YELNIK, Cécile, BITKER, Laurent, MEZIDI, Mehdi, YONIS, Hodane, BENECH, Nicolas, PERPOINT, Thomas, CONRAD, Anne, ICARD, Vinca, VALETTE, Martine, THIBERVILLE, Simon‐Djamel, REBAUDET, Stanislas, DUSSOL, Bertrand, DIAMANTIS, Sylvain, CHAKVEATZE, Catherine, FLATEAU, Clara, DINOT, Vincent, GACI, Rostane, OUAMARA, Nadia, ILLES, Hajnal‐Gabriela, GERBAUD MORLAES, Louis, DIMET, Jérôme, LE MOING, Vincent, PANSU, Nathalie, LE BIHAN, Clément, MONTES, Brigitte, Sophie BOUREAU, Anne, ALLAVENA, Clotilde, BOUCHEZ, Sabelline, GUERY, Romain, LE TURNIER, Paul, MEAR‐PASSARD, Cécile, FERRE, Virginie, RAPP, Christophe, DEMONCHY, Elisa, MICHELANGELLI, Céline, RISSO, Karine, LOUBET, Paul, LAVIGNE, Jean‐Phillippe, DE MONTMOLLIN, Etienne, PATRIER, Juliette, Henri WICKY, Paul, LE FEVRE, Lucie, JACQUET, Pierre, BORIE, Raphael, DOSSIER, Antoine, LUTON, Dominique, ISERNIA, Valentina, LE GAC, Sylvie, AZOULAY, Cécile, CARLIER, Nicolas, LUONG, Liem, LACHATRE, Marie, LAUNAY, Odile, KERROUMI, Younes, MEYSSONNIER, Vanina, DIEHL, Jean‐Luc, HULOT, Jean‐Sébastien, CHOLLEY, Bernard, ARLET, Jean‐Benoît, SANCHEZ, Olivier, MANDA, Victoria, AZEMAR, Laurène, CASTOR‐ALEXANDRE, Guylaine, LACOMBE, Karine, CHIARABINI, Thibault, LEFEBVRE, Bénédicte, MORAND‐JOUBERT, Laurence, FOFANA, Djeneba, SCHNURIGER, Aurélie, DE CASTRO, Nathalie, DELAUGERRE, Constance, CHAIX, Marie‐Laure, CHAS, Julie, GABORIEAU, Valérie, LE COUSTUMIER, Eve, PICARD, Walter, ZABBE, Jean‐Benoît, PEELMAN, Florent, SOUM, Edouard, AUMAÎTRE, Hugues, CURLIER, Elodie, OUISSA, Rachida, FABRE, Isabelle, RAMMAERT, Blandine, SAIDANI, Nadia, BANI‐SADR, Firouzé, HENTZIEN, Maxime, NGUYEN, Yohan, ROMARU, Juliette, DIDIER, Kévin, ENDERLE, Isabelle, THIBAULT, Vincent, LAINE, Fabrice, LESOUHAITIER, Matthieu, REVEST, Matthieu, TATTEVIN, Pierre, PLANTIER, Jean‐Christophe, LEMEE, Véronique, FERRAND DEVOUGE, Eglantine, ALEXANDRE, Kévin, ARTAUD‐MACCARI, Elise, ALLOU, Nathalie, LAGRANGE, Marie, JABOT, Julien, ROZE, Benoît, BREGEAUD, Delphine, AIT TAMLIHAT, Younes, HACHEMI, Ali, SALVATOR, Hélène, FOURN, Erwan, ZUCMAN, David, DELAVEUVE, Eric, JAUD‐FISCHER, Coline, DUNAND, Paul, BISSUEL, François, DELAVIGNE, Karen, PIEL‐JULIAN, Marie, DELOBEL, Pierre, SARTON, Benjamine, RAFIQ, Marie, MARTIN‐BLONDEL, Guillaume, GUILLEMINAULT, Laurent, MURRIS, Marlène, SOMMET, Agnès, SENNEVILLE, Eric, ROBINEAU, Olivier, MEYBECK, Agnès, GAROT, Denis, PLANTIER, Laurent, GISSOT, Valérie, MARLET, Julien, STEFIC, Karl, GAUDY‐GRAFFIN, Catherine, BARIN, Francis, LEMAIGNEN, Adrien, CORVAISIER, Grégory, LARIVIERE, Delphine, LANGELOT‐RICHARD, Marie, BOTELHO‐NEVERS, Elisabeth, GAGNEUX‐BRUNON, Amandine, TROUILLON, Tiffany, BOURLET, Thomas, PILLET, Sylvie, POZZETTO, Bruno, KIMMOUM, Antoine, LEVY, Bruno, MATTEI, Mathieu, GOEHRINGER, François, RABAUD, Christian, BEVILACQUA, Sibylle, LEFEVRE, Benjamin, GUILLAUMOT, Anne, VENARD, Véronique, JEULIN, Hélène, SCHVOERER, Evelyne, HARTARD, Cédric, CARAUX PAZ, Pauline, RICHIER, Laurent, EL SANHARAWI, Mohamed, Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, ANRS France Recherche Nord & sud Sida-hiv hépatites, France REcherche Nord & sud Sida-hiv Hépatites (FRENSH), CHU Amiens-Picardie, Agents infectieux, résistance et chimiothérapie - UR UPJV 4294 (AGIR ), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, French COVID cohort study group, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Laboratoire Chrono-environnement (UMR 6249) (LCE), Centre National de la Recherche Scientifique (CNRS)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Lille, Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Centre d'investigation clinique plurithématique Pierre Drouin [Nancy] (CIC-P), Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy] (INI-CRCT), Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu [Nancy], French-Clinical Research Infrastructure Network - F-CRIN [Paris] (Cardiovascular & Renal Clinical Trialists - CRCT ), CHU Rouen, Normandie Université (NU), and The Alliance for International Medical Action [Dakar, Sénégal] (ONG ALIMA)

Subjects
Adult, Male, medicine.medical_specialty, Multivariate analysis, Adolescent, prospective cohort, SARS‐CoV‐2, Cohort Studies, Young Adult, coronavirus disease 2019, 03 medical and health sciences, Patient Admission, 0302 clinical medicine, Risk Factors, Virology, Internal medicine, Diabetes mellitus, emerging infection diseases, medicine, Humans, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, Research Articles, Aged, Aged, 80 and over, SARS-CoV-2, Proportional hazards model, business.industry, Hazard ratio, Age Factors, COVID-19, Middle Aged, Viral Load, medicine.disease, Obesity, Confidence interval, Hospitalization, Infectious Diseases, Female, 030211 gastroenterology & hepatology, France, business, Viral load, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Research Article
Abstract

Little is known on the association between clinical factors and coronavirus disease 2019 (COVID‐19) more than 15 days after diagnosis. We conducted a multicentric prospective cohort of COVID‐19 hospitalized patients to describe clinical, biological, and virological characteristics at hospital admission and over time, according to mortality up to Day 60 after admission. For the analysis of risk factors of survival, analyses assessing associations between mortality and demographic characteristics or comorbidities were performed using a Cox regression model. Between January 24 and March 15, 2020, 246 patients with reverse‐transcriptase polymerase chain reactions virologically confirmed COVID‐19 were enrolled. In multivariate analysis, mortality at Day 60 (n = 42 patients, 17.1% [95% confidence interval, 12.6–22.4]) was associated with older age (adjusted hazard ratio [aHR] for age ≥ 65 years: 5.22 [2.56–10.63, p, Highlights Older age, male gender, chronic pulmonary disease (not asthma), obesity, and diabetes were associated with mortality in COVID‐19 hospitalized patients. Viral load at admission decreased with the time since symptom onset, with an association with mortality adjusted on clinical risk factors.

Published
2020

4. A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever

Author

Adebola Tolulope Olayinka, Josephine Bourner, George O. Akpede, Joseph Okoeguale, Chukwuyem Abejegah, Nnennaya A. Ajayi, Christian Akude, Oluwafemi Ayodeji, Daniel G. Bausch, Hilde de Clerck, Chioma Dan-Nwafor, Jake Dunning, Cyril Erameh, Justus Ndulue Eze, Pierre Formenty, Annelies Gillesen, Sulaiman Jalloh, Marie Jaspard, Tolulope Jegede, Jacob Maikere, Denis Malvy, Ephraim Ogbaini-Emovon, Olalekan Ezekial Ojo, Sylvanus Okogbenin, Kwame O’Neill, Maria-Lauretta Orji, Sampson Omagbemi Owhin, Michael Ramharter, Robert J. Samuels, Nathan Shehu, Laura Merson, Alex Paddy Salam, Nzelle Delphine Kayem, Peter Horby, Chikwe Ihekweazu, Piero Olliaro, Nigeria Centre for Disease Control [Abuja, Nigeria] (NCDC), Nuffield Department of Medicine [Oxford, UK] (Big Data Institute), University of Oxford, Alex Ekwueme Federal University Ndufu Alike, Nigeria, Bingham University, Public Health England [London], London School of Hygiene and Tropical Medicine (LSHTM), Médecins Sans Frontières Belgique, World Health Organisation (WHO), Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), The Alliance for International Medical Action [Dakar, Sénégal] (ONG ALIMA), Global Health in the Global South (GHiGS), Institut de Recherche pour le Développement (IRD)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Bernhard Nocht Institute for Tropical Medicine - Bernhard-Nocht-Institut für Tropenmedizin [Hamburg, Germany] (BNITM), Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), Kenema Government Hospital, Jos University Teaching Hospital [Nigeria], and Bill and Melinda Gates Foundation

Subjects
Questionnaires, Viral Diseases, Drug Research and Development, Critical Care and Emergency Medicine, Pulmonology, Maternal Health, RC955-962, Fevers, Pain, Research and Analysis Methods, Antiviral Agents, Respiratory Disorders, Medical Conditions, Lassa Fever, Signs and Symptoms, Respiratory Failure, Drug Development, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Pregnancy, Surveys and Questionnaires, Arctic medicine. Tropical medicine, Drug Discovery, Medicine and Health Sciences, Humans, Clinical Trials, Lassa virus, Acute Respiratory Distress Syndrome, Pharmacology, Survey Research, Public Health, Environmental and Occupational Health, Obstetrics and Gynecology, Tropical Diseases, Phase III clinical investigation, Abdominal Pain, Infectious Diseases, Clinical Trials, Phase III as Topic, Research Design, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Women's Health, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Clinical Medicine, Public aspects of medicine, RA1-1270, Research Article, Neglected Tropical Diseases
Abstract

Background Only one recommendation currently exists for the treatment of Lassa fever (LF), which is ribavirin administered in conjunction with supportive care. This recommendation is primarily based on evidence generated from a single clinical trial that was conducted more than 30 years ago–the methodology and results of which have recently come under scrutiny. The requirement for novel therapeutics and reassessment of ribavirin is therefore urgent. However, a significant amount of work now needs to be undertaken to ensure that future trials for LF can be conducted consistently and reliably to facilitate the efficient generation of evidence. Methodology We convened a consultation group to establish the position of clinicians and researchers on the core components of future trials. A Core Eligibility Criteria (CEC), Core Case Definition (CCD), Core Outcome Set (COS) and Core Data Variables (CDV) were developed through the process of a multi-stakeholder consultation that took place using a modified-Delphi methodology. Results A consensus position was achieved for each aspect of the framework, which accounts for the inclusion of pregnant women and children in future LF clinical trials. The framework consists of 8 core criteria, as well as additional considerations for trial protocols. Conclusions This project represents the first step towards delineating the clinical development pathway for new Lassa fever therapeutics, following a period of 40 years without advancement. Future planned projects will bolster the work initiated here to continue the advancement of LF clinical research through a regionally-centred, collaborative methodology, with the aim of delineating a clear pathway through which LF clinical trials can progress efficiently and ensure sustainable investments are made in research capacity at a regional level., Author summary Lassa fever (LF) is an acute viral haemorrhagic fever endemic to West Africa, causing an estimated 500,000 new infections and 10,000 deaths per year. At present, no treatment has been developed to specifically treat LF and only one prospective clinical trial has been conducted to evaluate the current treatment recommendation. Before a new era of LF clinical trials can begin, it is important to develop standardised methods and tools to ensure that trials are conducted in a consistent way and can generate reliable, comparable data. The aim of this project was initiate the first step to improve the comparability of LF studies by developing a standardised Phase III clinical trial methodology for LF therapeutics that could be applied in low-resource settings. Through multi-stakeholder consultation, we established a consensus position of clinicians and researchers on the core components of future Phase III clinical trials: Core Eligibility Criteria (CEC), Core Case Definition (CCD), Core Outcome Set (COS) and Core Data Variables (CDV).

Published
2022

5. Post-exposure prophylaxis following high-risk contact with Ebola virus, using immunotherapies with monoclonal antibodies, in the eastern Democratic Republic of the Congo: an emergency use program

Author

Placide Mbala, Denis Malvy, Issa Malam Kanta, Richard Kojan, Marie Jaspard, Baweye Mayoum, Sylvain Juchet, Béatrice Serra, Mohamed Seto Camara, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Recherche pour le Développement (IRD [France-Ouest]), The Alliance for International Medical Action [Dakar, Sénégal] (ONG ALIMA), Institut National de Recherche Biomédicale [Kinshasa] (INRB), CHU Bordeaux [Bordeaux], and Admin, Oskar

Subjects
Microbiology (medical), medicine.drug_class, medicine.medical_treatment, viruses, Ebola virus disease, Disease, Infectious and parasitic diseases, RC109-216, Antibodies, Monoclonal, Humanized, medicine.disease_cause, Monoclonal antibody, Post-exposure prophylaxis, Disease Outbreaks, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, medicine, Humans, 030212 general & internal medicine, 030304 developmental biology, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, 0303 health sciences, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Ebola virus, business.industry, Antibodies, Monoclonal, Outbreak, General Medicine, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, Hemorrhagic Fever, Ebola, Ebolavirus, Virology, 3. Good health, Drug Combinations, Infectious Diseases, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Democratic Republic of the Congo, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Monoclonal antibodies, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Immunotherapy, [SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy, Intermediate risk, business
Abstract

Introduction: With the development of therapeutics and vaccine against Ebola virus disease (EVD), the question of post-exposure prophylaxis for high-risk contact has emerged. Immunotherapies (monoclonal antibodies [mAbs]) recently validated for treating infected patients appear to be a good candidate for protecting contacts. Design: During the tenth EVD outbreak in the Democratic Republic of the Congo, we have administrated mAbs (Mab114 or REGN-EB3) to high and intermediate-risk contacts of EVD patients. Results: : Overall, 23 non-vaccinated contacts received mAbs after a median delay between contact and post-exposure prophylaxis of 1 day (interquartile range 1–2). All contacts were free of symptoms, and all had negative reverse transcriptase-polymerase chain reaction 14 days after the contact. Conclusion: Immunotherapies appear to be promising candidates to protect EVD contacts. Interaction with vaccine needs to be analyzed and a larger study on efficacy conducted.

Published
2021

6. Lassa fever clinical course and setting a standard of care for future randomized trials: A protocol for a cohort study of Lassa-infected patients in Nigeria (LASCOPE)

Author

Peter Horby, Marie Jaspard, Liasu Adeagbo Ahmed, Mahamadou Doutchi, Ephraim Ogbaini-Emovon, Bertine Siloué, Irmine Ahyi, Claire Levy-Marchal, Justine Schaeffer, Josephine Funmilola Alabi, Ijeoma Chukwudumebi Etafo, Alex P. Salam, Denis Malvy, Stephan Günther, Olufunke Gbenga-Ayeni, Adewale Oladayo Akinpelu, Larissa N'guessan-Koffi, Eric Ouattara, Delphine Gabillard, Johnson Etafo, Oyebimpe Ope Oyegunle, Chukwuyem Abejegah, Alexandre Duvignaud, Augustin Augier, Moronke Uzuajemeh Ireneh, Mamoudou Diabaté, Moses Adeniyi Adedokun, Kehinde Gbemisola Fadiminiyi, Sophie Karcher, B. Serra, Akinola Nelson Adedosu, Ayoleyi Omowunmi Dede, Patience Iziegbe Ehigbor, Oladele Oluwafemi Ayodeji, Macdonald Nonso Onyechi, Xavier Anglaret, Elvis Amani, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Programme PAC-CI, ANRS France Recherche Nord & sud Sida-hiv hépatites, Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS), Centre Hospitalier Universitaire de Treichville [Abidjan, Côte d'Ivoire] (CHU de Treichville), The Alliance for International Medical Action [Dakar, Sénégal] (ONG ALIMA), Université de Zinder - University of Zinder [Zinder, Niger], University of Oxford [Oxford], and Bernhard Nocht Institute for Tropical Medicine - Bernhard-Nocht-Institut für Tropenmedizin [Hamburg, Germany] (BNITM)

Subjects
medicine.medical_specialty, [SDV]Life Sciences [q-bio], 030231 tropical medicine, Nigeria, Viral hemorrhagic fever, law.invention, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Informed consent, Pregnancy, medicine, Humans, 030212 general & internal medicine, Prospective Studies, Intensive care medicine, Lassa fever, Prospective cohort study, Lassa virus, Randomized Controlled Trials as Topic, business.industry, Public Health, Environmental and Occupational Health, Standard of Care, medicine.disease, 3. Good health, Acute kidney injury, Clinical trial, Africa, Western, Infectious Diseases, Clinical research, Cohort, Female, business, Cohort study
Abstract

Background Lassa Fever (LF), is a severe viral disease prevalent in Western Africa. It is classified as a priority disease by the World Health Organization (WHO). Ribavirin is the recommended therapy despite weak evidence of its efficacy. Promising therapeutic agents are becoming available for evaluation in human. Before launching therapeutic trials, we need data on the evolution of the disease under the best possible conditions of care. Methods We have initiated a prospective study in Nigeria to better understand the clinical course and prognostic factors of LF while implementing high quality standardized care. Inclusion criteria are: suspected or confirmed LF and informed consent. Participants are followed 60 days from admission and receive free of charge standardized supportive care and biological monitoring, as well as intravenous ribavirin for those with confirmed LF. Data are collected using standardized case report forms (CRF). Primary and secondary outcomes are fatality and severe morbidity, with special focus on acute kidney dysfunction and pregnancy complications. Factors associated with outcomes will be investigated. Results The cohort is planned for 3 years. Inclusions started in April 2018 at the Federal Medical Center Owo in Ondo State. A second site will open in Nigeria in 2020 and discussions are underway to open a site in Benin. 150 to 200 new participants are expected per year. Conclusions This cohort will: provide evidence to standardize LF case management; provide key inputs to design future clinical trials of novel therapeutics; and establish clinical research teams capable of conducting such trials in LF-endemic areas. Study registration The LASCOPE study was registered on ClinicalTrial.gov (NCT03655561).

Published
2020

7. Favipiravir pharmacokinetics in Ebola-Infected patients of the JIKI trial reveals concentrations lower than targeted

Author

Nguyen, Thi Huyen Tram, Guedj, Jérémie, Anglaret, Xavier, Laouénan, Cédric, Madelain, Vincent, Taburet, Anne-Marie, Baize, Sylvain, Sissoko, Daouda, Pastorino, Boris, Rodallec, Anne, Piorkowski, Géraldine, Carazo, Sara, Conde, Mamoudou N, Gala, Jean-Luc, Bore, Joseph Akoi, Carbonnelle, Caroline, Jacquot, Frédéric, Raoul, Hervé, Malvy, Denis, de Lamballerie, Xavier, Mentré, France, JIKI study group, Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC), Programme PAC-CI, ANRS France Recherche Nord & sud Sida-hiv hépatites, Laboratoire de Biotechnologie et Microbiologie Appliquée (LBMA), Institut National de la Recherche Agronomique (INRA)-Université Bordeaux Segalen - Bordeaux 2, AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Biologie des Infections Virales Émergentes - Biology of Emerging Viral Infections (UBIVE), Centre International de Recherche en Infectiologie - UMR (CIRI), Institut National de la Santé et de la Recherche Médicale (INSERM)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut Pasteur [Paris], Emergence des Pathologies Virales (EPV), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU), Médecins Sans Frontières Belgique, The Alliance for International Medical Action [Dakar, Sénégal] (ONG ALIMA), Université Catholique de Louvain = Catholic University of Louvain (UCL), Laboratoire des Fièvres Hémorragiques en Guinée, Université Gamal Abdel Nasser de Conakry, Laboratoire P4 - Jean Mérieux, Centre Européen de Virologie/Immunologie-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM), The JIKI trial was supported by grants from the French National Agency for AIDS and viral hepatitis research (ANRS, Paris, France, http://www.anrs.fr/), the French Institute for Health Research (Inserm, Paris, France, http://www.inserm.fr/) and the European Commission (EU Horizon 2020 programme, grant N° 666092 - REACTION, http://ec.europa.eu/programmes/horizon2020/)., European Project: 666092,H2020,H2020-Adhoc-2014-20,REACTION(2014), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Bordeaux Segalen - Bordeaux 2-Institut National de la Recherche Agronomique (INRA), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut Pasteur [Paris] (IP), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut Pasteur [Paris], MATEO, MATHIEU, Evaluation of the efficacy and of the antiviral activity of T-705 (favipiravir) duringEbola virus infection in non-human primates humans - REACTION - - H20202014-11-01 - 2016-10-31 - 666092 - VALID, Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut Pasteur [Paris] (IP), UCL - SSS/IREC/CTMA - Centre de technologies moléculaires appliquées (plate-forme technologique), UCL - (SLuc) Centre de génétique médicale UCL, Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM), and Université Catholique de Louvain (UCL)

Subjects
Male, Physiology, Blood plasma, Biochemistry, MESH: Child, Medicine and Health Sciences, Viral load, Child, [SDV.MP.VIR] Life Sciences [q-bio]/Microbiology and Parasitology/Virology, MESH: Aged, MESH: Guinea, MESH: Middle Aged, Pharmaceutics, lcsh:Public aspects of medicine, Hematology, Middle Aged, Ebolavirus, MESH: Amides, Body Fluids, Blood, MESH: Young Adult, Child, Preschool, Pyrazines, Creatinine, MESH: Pyrazines, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Female, Drug therapy, Anatomy, Research Article, Adult, MESH: Antiviral Agents, lcsh:Arctic medicine. Tropical medicine, Adolescent, lcsh:RC955-962, Antiviral Agents, Microbiology, Young Adult, Virology, Albumins, Dose prediction methods, Humans, Pharmacokinetics, MESH: Ebolavirus, Aged, Pharmacology, MESH: Adolescent, MESH: Humans, MESH: Child, Preschool, Biology and Life Sciences, Proteins, lcsh:RA1-1270, MESH: Adult, Hemorrhagic Fever, Ebola, Amides, MESH: Male, MESH: Hemorrhagic Fever, Ebola, Guinea, MESH: Female, Biomarkers, Viral Transmission and Infection
Abstract

Background In 2014–2015, we assessed favipiravir tolerance and efficacy in patients with Ebola virus (EBOV) disease (EVD) in Guinea (JIKI trial). Because the drug had never been used before for this indication and that high concentrations of the drugs were needed to achieve antiviral efficacy against EBOV, a pharmacokinetic model had been used to propose relevant dosing regimen. Here we report the favipiravir plasma concentrations that were achieved in participants in the JIKI trial and put them in perspective with the model-based targeted concentrations. Methods and findings Pre-dose drug concentrations were collected at Day-2 and Day-4 of treatment in 66 patients of the JIKI trial and compared to those predicted by the model taking into account patient’s individual characteristics. At Day-2, the observed concentrations were slightly lower than the model predictions adjusted for patient’s characteristics (median value of 46.1 versus 54.3 μg/mL for observed and predicted concentrations, respectively, p = 0.012). However, the concentrations dropped at Day-4, which was not anticipated by the model (median values of 25.9 and 64.4 μg/mL for observed and predicted concentrations, respectively, p, Author summary In 2014–2015, the JIKI trial was conducted in Guinea to test favipiravir tolerance and efficacy in patients with Ebola virus disease (EDV). The main results of the trial were previously published without drug concentrations which were not available at the time of publication. The purpose of this study was to report favipiravir concentrations achieved in participants in the JIKI trial and to compare them with the targeted concentrations. We analyzed drug concentrations obtained at Day-2 and Day-4 and compared them to the targeted concentrations. At Day-2, favipiravir concentrations were significantly below but still close to the targeted concentration. At Day-4, a significant and unanticipated drop of concentrations as compared to Day-2 was observed. The origin of the lower-than-targeted concentrations and the unexpected drop could be due to severe sepsis conditions and/or to intrinsic properties of favipiravir metabolism. No significant correlation was found between the drug exposure and the virological response, indicating that it is possible that the favipiravir concentrations in the JIKI trial were not sufficient to strongly inhibit the viral replication. These findings suggest the necessity of performing dose-ranging studies with high doses of favipiravir in healthy volunteers to inform any further development of favipiravir for treatment of EVD.

Published
2017

8. Vaccination and blood sampling acceptability during Ramadan fasting month: A cross-sectional study in Conakry, Guinea

Author

Abdoul Habib Beavogui, Vinh-Kim Nguyen, Zahra Zeggani, Sylvain Landry Faye, Eric D'Ortenzio, Yazdan Yazdanpanah, Ramatou Ouedraogo, Papa Ndiaga Cisse, Nathan Peiffer-Smadja, Frédéric Le Marcis, Dupuis, Christine, Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service des maladies infectieuses et tropicales, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Les Afriques dans le monde (LAM), Sciences Po Bordeaux - Institut d'études politiques de Bordeaux (IEP Bordeaux)-Institut de Recherche pour le Développement (IRD)-Institut d'Études Politiques [IEP] - Bordeaux-Université Bordeaux Montaigne-Centre National de la Recherche Scientifique (CNRS), Fondation Maison des sciences de l'homme (FMSH), Département de Sociologie [Dakar, Sénégal], Université Cheikh Anta Diop [Dakar, Sénégal] (UCAD), The Alliance for International Medical Action [Dakar, Sénégal] (ONG ALIMA), Centre National de Formation et de Recherche en Santé Rurale [Maférinyah, Guinée] (CNFRSR), Département de Parasitologie et Mycologie [Conakry, Guinée], Université Gamal Abdel Nasser de Conakry, Laboratoire d’Anthropologie Des Enjeux Contemporains (LADEC), École normale supérieure - Lyon (ENS Lyon)-Université Lumière - Lyon 2 (UL2)-Centre National de la Recherche Scientifique (CNRS), Ecole de Santé Publique de l'Université de Montréal, Université de Montréal (UdeM), Graduate Institute of International and Development Studies [Geneva, Switzerland] (Institut de hautes études internationales et du développement), This work was supported by the National Institutes of Health and by the Institut national de la santé et de la recherche médicale., Sciences Po Bordeaux - Institut d'études politiques de Bordeaux (IEP Bordeaux)-Institut de Recherche pour le Développement (IRD)-Institut d'Études Politiques [IEP] - Bordeaux-Université Bordeaux Montaigne (UBM)-Centre National de la Recherche Scientifique (CNRS), École normale supérieure de Lyon (ENS de Lyon)-Université Lumière - Lyon 2 (UL2)-Centre National de la Recherche Scientifique (CNRS), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)

Subjects
Male, Pediatrics, medicine.medical_specialty, Blood sampling, Cross-sectional study, 030231 tropical medicine, Islam, West africa, 03 medical and health sciences, 0302 clinical medicine, Acceptability, Muslim countries, Surveys and Questionnaires, West Africa, Humans, Medicine, 030212 general & internal medicine, Adverse effect, Vaccines, Ramadan, General Veterinary, General Immunology and Microbiology, business.industry, Vaccination, Public Health, Environmental and Occupational Health, Fasting, Patient Acceptance of Health Care, humanities, 3. Good health, Clinical trial, Cross-Sectional Studies, Infectious Diseases, Vaccination Campaigns, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Molecular Medicine, Female, Guinea, Immunization, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Blood Chemical Analysis, Demography
Abstract

International audience; INTRODUCTION:There are few data on the acceptability of vaccination or blood sampling during Ramadan fasting month in Muslim countries. This could impact vaccination campaigns, clinical trials or healthcare during Ramadan.METHODS:Using a semi-structured questionnaire, we conducted a cross-sectional study on 201 practising Muslims and 10 religious leaders in Conakry, Guinea in the wake of the recent epidemic Ebola epidemic. Acceptability of vaccination and blood sampling during Ramadan were investigated as well as reasons for refusal.RESULTS:Vaccination was judged acceptable during Ramadan by 46% (93/201, 95% CI 0.40-0.53) of practising Muslims versus 80% (8/10, 95% CI 0.49-0.94) of religious leaders (p=0.11). Blood sampling was judged acceptable during Ramadan by 54% (108/201, 95% CI 0.47-0.60) of practising Muslims versus 80% (8/10, 95% CI 0.49-0.94) of religious leaders (p=0.19). The percentage of participants that judged both blood sampling and vaccination acceptable during Ramadan was 40% (81/201, 95% CI 0.34-0.47) for practising Muslims versus 80% (8/10, 95% CI 0.49-0.94) for religious leaders (p=0.048). The most common reasons for refusal of vaccination or blood sampling were that nothing should enter or leave the body during Ramadan (43%), that adverse events could lead to breaking the fast (32%), that blood should not be seen during Ramadan (9%) and that the Quran explicitly forbids it (9%).DISCUSSION:Although most Muslims leaders and scientists consider that injections including immunization and blood sampling should be authorized during Ramadan, many Muslims in our study judged vaccination or blood sampling unacceptable when fasting. Widely available recommendations on healthcare during Ramadan would be useful to inform Muslims.

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