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1. 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

2. Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia

Author

Hermine, Olivier, Mariette, Xavier, Tharaux, Pierre-Louis, Resche-Rigon, Matthieu, Porcher, Raphaël, Ravaud, Philippe, Bureau, Serge, Dougados, Maxime, Tibi, Annick, Azoulay, Elie, Cadranel, Jacques, Emmerich, Joseph, Fartoukh, Muriel, Guidet, Bertrand, Humbert, Marc, Lacombe, Karine, Mahevas, Matthieu, Pene, Frédéric, Pourchet-Martinez, Valérie, Schlemmer, Frédéric, Yazdanpanah, Yazdan, Baron, Gabriel, Perrodeau, Elodie, Vanhoye, Damien, Kedzia, Cécile, Demerville, Lauren, Gysembergh-Houal, Anne, Bourgoin, Alexandre, Dalibey, Sarah, Raked, Nabil, Mameri, Lakhdar, Alary, Stéphanie, Hamiria, Samir, Bariz, Thinhinane, Semri, Hala, Hai, Dhiaa Meriem, Benafla, Moustafa, Belloul, Mohamed, Vauboin, Pernelle, Flamand, Saskia, Pacheco, Claire, Walter-Petrich, Anouk, Stan, Emilia, Benarab, Souad, Nyanou, Corine, Montlahuc, Claire, Biard, Lucie, Charreteur, Robin, Dupré, Celine, Cardet, Kévin, Lehmann, Blandine, Baghli, Kamyl, Madeleine, Claire, DOrtenzio, Eric, Puéchal, Oriane, Semaille, Caroline, Savale, Laurent, Harrois, Anatole, Figueiredo, Samy, Duranteau, Jacques, Anguel, Nadia, Monnet, Xavier, Richard, Christian, Teboul, Jean-Louis, Durand, Philippe, Tissieres, Pierre, Jevnikar, Mitja, Montani, David, Pavy, Stéphan, Noel, Nicolas, Lambotte, Olivier, Escaut, Lelia, Jauréguiberry, Stéphane, Baudry, Elodie, Verny, Christiane, Lefèvre, Edouard, Zaidan, Mohamad, Le Tiec, Clotilde Le Tiec, Verstuyft, Céline Verstuyft, Roques, Anne-Marie, Grimaldi, Lamiae, Molinari, Domitille, Leprun, Gaël, Fourreau, Alain, Cylly, Laurent, Virlouvet, Myriam, Meftali, Ramdane, Fabre, Solène, Licois, Marion, Mamoune, Asmaa, Boudali, Yacine, Georgin-Lavialle, Sophie, Senet, Patricia, Soria, Angèle, Parrot, Antoine, François, Hélène, Rozensztajn, Nathalie, Blin, Emmanuelle, Choinier, Pascaline, Camuset, Juliette, Rech, Jean-Simon, Canellas, Antony, Rolland-Debord, Camille, Lemarié, Nadège, Belaube, Nicolas, Nadal, Marine, Siguier, Martin, Petit-Hoang, Camille, Chas, Julie, Drouet, Elodie, Lemoine, Matthieu, Phibel, Audrey, Aunay, Lucie, Bertrand, Eliane, Ravato, Sylviane, Vayssettes, Marie, Adda, Anne, Wilpotte, Celine, Thibaut, Pélagie, Fillon, Julie, Debrix, Isabelle, Fellahi, Soraya, Bastard, Jean-Philippe, Lefèvre, Guillaume, Fallet, Vincent, Gottenberg, Jacques-Eric, Hansmann, Yves, Andres, Emmanuel, Bayer, Sophie, Becker, Guillaume, Blanc, Frédéric, Brin, Stéphane, Castelain, Vincent, Chatelus, Emmanuel, Chatron, Eva, Collange, Olivier, Danion, François, De Blay, Frédéric, Demonsant, Eric, Diemunsch, Pierre, Diemunsch, Sophie, Felten, Renaud, Goichot, Bernard, Greigert, Valentin, Guffroy, Aurélien, Heger, Bob, Hutt, Anne, Kaeuffer, Charlotte, Kassegne, Loic, Korganow, Anne Sophie, Le Borgne, Pierrick, Lefebvre, Nicolas, Martin, Tristan, Mertes, Paul Michel, Metzger, Catherine, Meyer, Nicolas, Nisand, Gabriel, Noll, Eric, Oberlin, Mathieu, Ohlmann-Caillard, Sophie, Poindron, Vincent, Pottecher, Julien, Ruch, Yvon, Sublon, Cédric, Tayebi, Hakim, Weill, François, Mekinian, Arsène, Chopin, Dorothée, Fain, Olivier, Garnier, Marc, Krause Le Garrec, Jessica, Morgand, Marjolaine, Pacanowski, Jerome, Urbina, Tomas, Mcavoy, Chloe, Pereira, Maria, Aratus, Gladys, Berard, Laurence, Simon, Tabassome, Daguenel Nguyen, Anne, Antignac, Marie, Leplay, Céline, Arlet, Jean-Benoit, Diehl, Jean-Luc, Bellenfant, Florence, Blanchard, Anne, Buffet, Alexandre, Cholley, Bernard, Fayol, Antoine, Flamarion, Edouard, Godier, Anne, Gorget, Thomas, Hamada, Sophie-Rym, Hauw-Berlemont, Caroline, Hulot, Jean- Se´bastien, Lebeaux, David, Livrozet, Marine, Michon, Adrien, Neuschwander, Arthur, Penet, Marie-Aude, Planquette, Benjamin, Ranque, Brigitte, Sanchez, Olivier, Volle, Geoffroy, Briois, Sandrine, Cornic, Mathias, Elisee, Virginie, Jesuthasan, Denis, Djadi-Prat, Juliette, Jouany, Pauline, Junquera, Ramon, Henriques, Mickael, Kebir, Amina, Lehir, Isabelle, Meunier, Jeanne, Patin, Florence, Paquet, Vale´rie, Tre´Han, Anne, Vigna, Ve´ronique, Sabatier, Brigitte, Bergerot, Damien, Jouve, Charle`ne, Knosp, Camille, Lenoir, Olivia, Mahtal, Nassim, Resmini, Léa, Lescure, Xavier, Ghosn, Jade, Bachelard, Antoine, Bironne, Timothee, Borie, Raphael, Bounhiol, Agathe, Boussard, Catherine, Chauffier, Jeanne, Chalal, Solaya, Chalal, Lynda, Chansombat, Malikhone, Crespin, Paul, Crestani, Bruno, Daconceicao, Olivia, Deconinck, Laurene, Dieude, hilippe, Dossier, Antoine, Dubert, Marie, Ducrocq, Greggory, Fuentes, Axelle, Gervais, Anne, Gilbert, Marie, Isernia, Valentina, Ismael, Sophie, Joly, Veronique, Julia, Zelie, Lariven, Sylvie, Le Gac, Sylvie, Le Pluart, Diane, Louni, Francoise, Ndiaye, Awa, Papo, Thomas, Parisey, Marion, Phung, Bao, Pourbaix, Annabelle, Rachline, Anne, Rioux, Christophe, Sautereau, Aurelie, Steg, Gabriel, Tharini, Hassan, Valayer, Simon, Vallois, Dorothee, Vermes, Paul, Volpe, Thomas, Nguyen, Yann, Honsel, Vasco, Weiss, Emmanuel, Codorniu, Anaïs, Zarrouk, Virginie, De Lastours, Victoire, Uzzan, Matthieu, Gamany, Naura, Rahli, Roza, Louis, Zeina, Boutboul, David, Galicier, Lionel, Amara, Yaël, Archer, Gabrielle, Benattia, Amira, Bergeron, Anne, Bondeelle, Louise, De Castro, Nathalie, Clément, Melissa, Darmont, Michaël, Denis, Blandine, Dupin, Clairelyne, Feredj, Elsa, Feyeux, Delphine, Joseph, Adrien, Lengliné, Etienne, Le Guen, Pierre, Liégeon, Geoffroy, Lorillon, Gwenaël, Mabrouki, Asmaa, Mariotte, Eric, Martin De Frémont, Grégoire, Mirouse, Adrien, Molina, Jean-Michel, Peffault De Latour, Régis, Oksenhendler, Eric, Saussereau, Julien, Tazi, Abdellatif, Tudesq, Jean-Jacques, Zafrani, Lara, Brindele, Isabelle, Bugnet, Emmanuelle, Celli Lebras, Karine, Chabert, Julien, Djaghout, Lalia, Fauvaux, Catherine, Jegu, Anne Lise, Kozaliewicz, Ewa, Meunier, Martine, Tremorin, Marie-Thérèse, Davoine, Claire, Madeleine, Isabelle, Caillat-Zucman, Sophie, Delaugerre, Constance, Morin, Florence, Sene, Damien, Burlacu, Ruxandra, Chousterman, Benjamin, Megarbane, Bruno, Richette, Pascal, Riveline, Jean-Pierre, Frazier, Aline, Vicaut, Eric, Berton, Laure, Hadjam, Tassadit, Vasquez-Ibarra, Miguel Alejandro, Jourdaine, Clément, Jacob, Aude, Smati, Julie, Renaud, Stéphane, Manivet, Philippe, Pernin, Claire, Suarez, Lydia, Semerano, Luca, Abad, Sebastien, Benainous, Ruben, Bloch Queyrat, Coralie, Bonnet, Nicolas, Brahmi, Sabrina, Cailhol, johann, Cohen, Yves, Comparon, Celine, Cordel, Hugues, Dhote, Robin, Dournon, Nathalie, Duchemann, Boris, Ebstein, Nathan, Giroux-Leprieur, Benedicte, Goupil De Bouille, Jeanne, Jacolot, Anne, Nunes, Hilario, Oziel, Johanna, Rathouin, Vanessa, Rigal, Marthe, Roulot, Dominique, Tantet, Claire, Uzunhan, Yurdagul, Costedoat-Chalumeau, Nathalie, Ait Hamou, Zakaria, Benghanem, Sarah, Blanche, Philippe, Canoui, Etienne, Carlier, Nicolas, Chaigne, Benjamin, Contejean, Adrien, Dunogue, Bertrand, Dupland, Pierre, Durel - Maurisse, Aurélie, Gauzit, Remy, Jaubert, Paul, Joumaa, Hassan, Jozwiak, Mathieu, Kerneis, Solen, Lachatre, Marie, Lafoeste, Hélène, Legendre, Paul, Luong Nguyen, Liem Binh, Marey, Jonathan, Morbieu, Caroline, Mouthon, Luc, Nguyen, Lee, Palmieri, Lola-Jade, Regent, Alexis, Szwebel, Tali-Anne, Terrier, Benjamin, Guerin, Corinne, Zerbit, Jérémie, Cheref, Kahina, Chitour, Kamil, Cisse, Mamadou Salif, Clarke, Ada, Clavere, Gaelle, Dusanter, Isabelle, Gaudefroy, Caroline, Jallouli, Moez, Kolta, Sami, Le Bourlout, Catherine, Marin, Nathalie, Menage, Nathalie, Moores, Alexandre, Peigney, Isabelle, Pierron, Cédric, Saleh-Mghir, Samira, Vallet, Mathilde, Michel, Marc, Melica, Giovanna, Lelievre, Jean-Daniel, Fois, Elena, Lim, Pascal, Matignon, Marie, Guillaud, Constance, Thiemele, Alaki, Schmitz, David, Bouhris, Marion, Belazouz, Syllia, Languille, Laetitia, Mekontso-Dessaps, Armand, Sadaoui, Thiziri, Mayaux, Julien, Cacoub, Patrice, Corvol, Jean-Christophe, Louapre, Céline, Sambin, Sara, Mariani, Louise-Laure, Karachi, Carine, Tubach, Florence, Estellat, Candice, Gimeno, Linda, Martin, Karine, Bah, Aïcha, Keo, Vixra, Ouamri, Sabrine, Messaoudi, Yasmine, Yelles, Nessima, Faye, Pierre, Cavelot, Sébastien, Larcheveque, Cecile, Annonay, Laurence, Benhida, Jaouad, Zahrate-Ghoul, Aida, Hammal, Soumeya, Belilita, Ridha, Lecronier, Marie, Beurton, Alexandra, Haudebourg, Luc, Deleris, Robin, Le Marec, Julien, Virolle, Sara, Nemlaghi, Safaa, Bureau, Côme, Mora, Pierre, De Sarcus, Martin, Clovet, Olivier, Duceau, Baptiste, Grisot, Paul Henri, Pari, Marie hélène, Arzoine, Jérémy, Clarac, Ulrich, Faure, Morgane, Delemazure, Julie, Decavele, Maxence, Morawiec, Elise, Demoule, Alexandre, Dres, Martin, Vautier, Mathieu, Allenbach, Yves, Benveniste, Olivier, Leroux, Gaelle, Rigolet, Aude, Guillaume-Jugnot, Perrine, Domont, Fanny, Desbois, Anne Claire, Comarmond, Cloé, Champtiaux, Nicolas, Toquet, Segolene, Ghembaza, Amine, Vieira, Matheus, Maalouf, Georgina, Boleto, Gonçalo, Ferfar, Yasmina, Charbonnier, Fanny, Aguilar, Claire, Alby-Laurent, Fanny, Alyanakian, Marie-Alexandra, Bakouboula, Prissile, Broissand, Christine, Burger, Carole, Campos-Vega, Clara, Chavarot, Nathalie, Choupeaux, Laure, Elie, Caroline, Fournier, Benjamin, Granville, Sophie, Issorat, Elodie, Rouzaud, Claire, Vimpere, Damien, Geri, Guillaume, Derridj, Nawal, Sguiouar, Naima, Meddah, Hakim, Djadel, Mourad, Chambrin-Lauvray, Helene, Duclos-Vallée, Jean-Charles, Saliba, Faouzi, Sacleux, Sophie-Caroline, Koumis, Ilias, Michot, Jean-Marie, Stoclin, Annabelle, Colomba, Emeline, Pommeret, Fanny, Willekens, Chistophe, Da Silva, Rosa, Dejean, Valérie, Mekid, Yasmina, Ben-Mabrouk, Ines, Pradon, Caroline, Drouard, Laurence, Camara-Clayette, Valérie, Morel, Alexandre, Garcia, Gilles, Mohebbi, Abolfazl, Berbour, Férial, Dehais, Mélanie, Pouliquen, Anne-Lise, Klasen, Alison, Soyez-Herkert, Loren, London, Jonathan, Keroumi, Younes, Guillot, Emmanuelle, Grailles, Guillaume, El Amine, Younes, Defrancq, Fanny, Fodil, Hanane, Bouras, Chaouki, Dautel, Dominique, Gambier, Nicolas, Dieye, Thierno, Bienvenu, Boris, Lancon, Victor, Lecomte, Laurence, Beziriganyan, Kristina, Asselate, Belkacem, Allanic, Laure, Kiouris, Elena, Legros, Marie-Hélène, Lemagner, Christine, Martel, Pascal, Provitolo, Vincent, Ackermann, Félix, Le Marchand, Mathilde, Clan Hew Wai, Aurélie, Fremont, Dimitri, Coupez, Elisabeth, Adda, Mireille, Duée, Frédéric, Bernard, Lise, Gros, Antoine, Henry, Estelle, Courtin, Claire, Pattyn, Anne, Guinot, Pierre-Grégoire, Bardou, Marc, Maurer, Agnes, Jambon, Julie, Cransac, Amélie, Pernot, Corinne, Mourvillier, Bruno, Servettaz, Amélie, Deslée, Gaetan, Wynckel, Alain, Benoit, Philippe, Marquis, Eric, Roux, Damien, Gernez, Coralie, Yelnik, Cécile, Poissy, Julien, Nizard, Mandy, Denies, Fanette, Gros, Hélène, Mourad, Jean-Jacques, Sacco, Emmanuelle, Renet, Sophie, CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Service de Rhumatologie [CHU Bicêtre], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Immunologie des Maladies Virales et Autoimmunes (IMVA - U1184), Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Equipe 2 : ECSTRA - Epidémiologie Clinique, STatistique, pour la Recherche en Santé (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hopital Saint-Louis [AP-HP] (AP-HP), Centre d'épidémiologie Clinique [Hôtel-Dieu], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Hôtel Dieu, CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Saint-Antoine [AP-HP], Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Centre de recherche en Myologie – U974 SU-INSERM, Service de Département de médecine interne et immunologie clinique [CHU Pitié-Salpêtrière] (DMIIC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CORIMUNO-19 Collaborative Group, Porcher, Raphaël, Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158), and ANR-21-COVR-0024,ACT-LONG-COVID,Caractérisation clinique et biologique du syndrome d'activation mastocytaire dans le COVID long et prédisposition génétique(2021)

Subjects
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Internal Medicine
Abstract

International audience; Importance Severe pneumonia with hyperinflammation and elevated interleukin-6 is a common presentation of coronavirus disease 2019 (COVID-19).Objective To determine whether tocilizumab (TCZ) improves outcomes of patients hospitalized with moderate-to-severe COVID-19 pneumonia.Design, Setting, and Particpants This cohort-embedded, investigator-initiated, multicenter, open-label, bayesian randomized clinical trial investigating patients with COVID-19 and moderate or severe pneumonia requiring at least 3 L/min of oxygen but without ventilation or admission to the intensive care unit was conducted between March 31, 2020, to April 18, 2020, with follow-up through 28 days. Patients were recruited from 9 university hospitals in France. Analyses were performed on an intention-to-treat basis with no correction for multiplicity for secondary outcomes.Interventions Patients were randomly assigned to receive TCZ, 8 mg/kg, intravenously plus usual care on day 1 and on day 3 if clinically indicated (TCZ group) or to receive usual care alone (UC group). Usual care included antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants.Main Outcomes and Measures Primary outcomes were scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 4 and survival without need of ventilation (including noninvasive ventilation) at day 14. Secondary outcomes were clinical status assessed with the WHO-CPS scores at day 7 and day 14, overall survival, time to discharge, time to oxygen supply independency, biological factors such as C-reactive protein level, and adverse events.Results Of 131 patients, 64 patients were randomly assigned to the TCZ group and 67 to UC group; 1 patient in the TCZ group withdrew consent and was not included in the analysis. Of the 130 patients, 42 were women (32%), and median (interquartile range) age was 64 (57.1-74.3) years. In the TCZ group, 12 patients had a WHO-CPS score greater than 5 at day 4 vs 19 in the UC group (median posterior absolute risk difference [ARD] −9.0%; 90% credible interval [CrI], −21.0 to 3.1), with a posterior probability of negative ARD of 89.0% not achieving the 95% predefined efficacy threshold. At day 14, 12% (95% CI −28% to 4%) fewer patients needed noninvasive ventilation (NIV) or mechanical ventilation (MV) or died in the TCZ group than in the UC group (24% vs 36%, median posterior hazard ratio [HR] 0.58; 90% CrI, 0.33-1.00), with a posterior probability of HR less than 1 of 95.0%, achieving the predefined efficacy threshold. The HR for MV or death was 0.58 (90% CrI, 0.30 to 1.09). At day 28, 7 patients had died in the TCZ group and 8 in the UC group (adjusted HR, 0.92; 95% CI 0.33-2.53). Serious adverse events occurred in 20 (32%) patients in the TCZ group and 29 (43%) in the UC group (P = .21).Conclusions and Relevance In this randomized clinical trial of patients with COVID-19 and pneumonia requiring oxygen support but not admitted to the intensive care unit, TCZ did not reduce WHO-CPS scores lower than 5 at day 4 but might have reduced the risk of NIV, MV, or death by day 14. No difference on day 28 mortality was found. Further studies are necessary for confirming these preliminary results.Trial Registration ClinicalTrials.gov Identifier: NCT04331808

Published
2021
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3. Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

Author

Sissoko, Daouda, Laouenan, Cedric, Folkesson, Elin, M'Lebing, Abdoul-Bing, Beavogui, Abdoul-Habib, Baize, Sylvain, Camara, Alseny-Modet, Maes, Piet, Shepherd, Susan, Danel, Christine, Carazo, Sara, Conde, Mamoudou N., Gala, Jean-Luc, Colin, Géraldine, Savini, Hélène, Bore, Joseph Akoi, Le Marcis, Frederic, Koundouno, Fara Raymond, Petitjean, Frédéric, Lamah, Marie-Claire, Diederich, Sandra, Tounkara, Alexis, Poelart, Geertrui, Berbain, Emmanuel, Dindart, Jean-Michel, Duraffour, Sophie, Lefevre, Annabelle, Leno, Tamba, Peyrouset, Olivier, Irenge, Léonid, Bangoura, N'Famara, Palich, Romain, Hinzmann, Julia, Kraus, Annette, Barry, Thierno Sadou, Berette, Sakoba, Bongono, André, Camara, Mohamed Seto, Chanfreau Munoz, Valérie, Doumbouya, Lanciné, Souley Harouna, Kighoma, Patient Mumbere, Koundouno, Fara Roger, Réné Lolamou, Loua, Cécé Moriba, Massala, Vincent, Moumouni, Kinda, Provost, Célia, Samake, Nenefing, Sekou, Conde, Soumah, Abdoulaye, Arnould, Isabelle, Komano, Michel Saa, Gustin, Lina, Berutto, Carlotta, Camara, Diarra, Camara, Fodé Saydou, Colpaert, Joliene, Delamou, Léontine, Jansson, Lena, Kourouma, Etienne, Loua, Maurice, Malme, Kristian, Manfrin, Emma, Maomou, André, Milinouno, Adele, Ombelet, Sien, Sidiboun, Aboubacar Youla, Verreckt, Isabelle, Yombouno, Pauline, Bocquin, Anne, Carbonnelle, Caroline, Carmoi, Thierry, Frange, Pierre, Mely, Stéphane, Nguyen, Vinh-Kim, Pannetier, Delphine, Taburet, Anne-Marie, Treluyer, Jean-Marc, Kolie, Jacques, Moh, Raoul, Gonzalez, Minerva Cervantes, Kuisma, Eeva, Liedigk, Britta, Ngabo, Didier, Rudolf, Martin, Thom, Ruth, Kerber, Romy, Gabriel, Martin, Di Caro, Antonino, Wölfel, Roman, Badir, Jamal, Bentahir, Mostafa, Deccache, Yann, Dumont, Catherine, Durant, Jean-François, El Bakkouri, Karim, Gasasira Uwamahoro, Marie, Smits, Benjamin, Toufik, Nora, Van Cauwenberghe, Stéphane, Ezzedine, Khaled, Dortenzio, Eric, Pizarro, Louis, Etienne, Aurélie, Guedj, Jérémie, Fizet, Alexandra, Barte de Sainte Fare, Eric, Murgue, Bernadette, Tran-Minh, Tuan, Rapp, Christophe, Piguet, Pascal, Poncin, Marc, Draguez, Bertrand, Allaford Duverger, Thierry, Barbe, Solenne, Baret, Guillaume, Defourny, Isabelle, Carroll, Miles, Raoul, Hervé, Augier, Augustin, Eholie, Serge P., Yazdanpanah, Yazdan, Levy-Marchal, Claire, Antierrens, Annick, Van Herp, Michel, Günther, Stephan, de Lamballerie, Xavier, Keïta, Sakoba, Mentre, France, Anglaret, Xavier, and Malvy, Denis

Subjects
Ebola hemorrhagic fever -- Drug therapy, Antiviral agents -- Patient outcomes, Biological sciences
Abstract

Background Ebola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care. Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies. Methods and Findings Inclusion criteria were positive Ebola virus reverse transcription PCR (RT-PCR) test, age [greater than or equal to] 1 y, weight [greater than or equal to] 10 kg, ability to take oral drugs, and informed consent. All participants received oral favipiravir (day 0: 6,000 mg; day 1 to day 9: 2,400 mg/d). Semi-quantitative Ebola virus RT-PCR (results expressed in 'cycle threshold' [Ct]) and biochemistry tests were performed at day 0, day 2, day 4, end of symptoms, day 14, and day 30. Frozen samples were shipped to a reference biosafety level 4 laboratory for RNA viral load measurement using a quantitative reference technique (genome copies/milliliter). Outcomes were mortality, viral load evolution, and adverse events. The analysis was stratified by age and Ct value. A 'target value' of mortality was defined a priori for each stratum, to guide the interpretation of interim and final analysis. Between 17 December 2014 and 8 April 2015, 126 patients were included, of whom 111 were analyzed (adults and adolescents, [greater than or equal to]13 y, n = 99; young children, [less than or equal to]6 y, n = 12). Here we present the results obtained in the 99 adults and adolescents. Of these, 55 had a baseline Ct value [greater than or equal to] 20 (Group A Ct [greater than or equal to] 20), and 44 had a baseline Ct value < 20 (Group A Ct < 20). Ct values and RNA viral loads were well correlated, with Ct = 20 corresponding to RNA viral load = 7.7 log.sub.10 genome copies/ml. Mortality was 20% (95% CI 11.6%-32.4%) in Group A Ct [greater than or equal to] 20 and 91% (95% CI 78.8%-91.1%) in Group A Ct < 20. Both mortality 95% CIs included the predefined target value (30% and 85%, respectively). Baseline serum creatinine was [greater than or equal to]110 [mu]mol/l in 48% of patients in Group A Ct [greater than or equal to] 20 ([greater than or equal to]300 [mu]mol/l in 14%) and in 90% of patients in Group A Ct < 20 ([greater than or equal to]300 [mu]mol/l in 44%). In Group A Ct [greater than or equal to] 20, 17% of patients with baseline creatinine [greater than or equal to]110 [mu]mol/l died, versus 97% in Group A Ct < 20. In patients who survived, the mean decrease in viral load was 0.33 log.sub.10 copies/ml per day of follow-up. RNA viral load values and mortality were not significantly different between adults starting favipiravir within Conclusions In the context of an outbreak at its peak, with crowded care centers, randomizing patients to receive either standard care or standard care plus an experimental drug was not felt to be appropriate. We did a non-randomized trial. This trial reaches nuanced conclusions. On the one hand, we do not conclude on the efficacy of the drug, and our conclusions on tolerance, although encouraging, are not as firm as they could have been if we had used randomization. On the other hand, we learned about how to quickly set up and run an Ebola trial, in close relationship with the community and non-governmental organizations; we integrated research into care so that it improved care; and we generated knowledge on EVD that is useful to further research. Our data illustrate the frequency of renal dysfunction and the powerful prognostic value of low Ct values. They suggest that drug trials in EVD should systematically stratify analyses by baseline Ct value, as a surrogate of viral load. They also suggest that favipiravir monotherapy merits further study in patients with medium to high viremia, but not in those with very high viremia. Trial registration ClinicalTrials.gov NCT02329054, Author(s): Daouda Sissoko 1,2, Cedric Laouenan 3,4, Elin Folkesson 5, Abdoul-Bing M'Lebing 6, Abdoul-Habib Beavogui 7, Sylvain Baize 8,9, Alseny-Modet Camara 5, Piet Maes 10,11, Susan Shepherd 6, Christine Danel [...]

Published
2016
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