Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE)
Alexandre Duvignaud, Edouard Lhomme, Racha Onaisi, Rémi Sitta, Ambre Gelley, Julie Chastang, Lionel Piroth, Christine Binquet, Julie Dupouy, Alain Makinson, Benjamin Lefèvre, Jean-Marc Naccache, Caroline Roussillon, Roland Landman, Cédrick Wallet, Sophie Karcher, Valérie Journot, Duc Nguyen, Thierry Pistone, Stéphane Bouchet, Marie-Edith Lafon, Mathieu Molimard, Rodolphe Thiébaut, Xavier De Lamballerie, Jean-Philippe Joseph, Laura Richert, Olivier Saint-Lary, Sarah Djabarouti, Linda Wittkop, Xavier Anglaret, Denis Malvy
Clinical Microbiology and Infection, doi:10.1016/j.cmi.2022.02.031
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Author contribution statement Alexandre Duvignaud (AD), Edouard Lhomme (EL), Racha Onaisi, Rémi Sitta (RS), Duc Nguyen (DN), Thierry Pistone (TP), Rodolphe Thiébaut, Jean-Philippe Joseph, Laura Richert (LR), Linda
Confit of interest All authors declare no conflict of interest.
Trial registration The trial protocol was registered in the European database EudraCT (2020-001435-27) and on clinicaltrials.gov (NCT04356495).
J o u r n a l P r e -p r o o f
Role of funding source The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
J o u r n a l P r e -p r o o f
LIST OF FIGURES Figure 1. CONSORT Flow Diagram
Footnotes to Figure 1 This figure shows the flow of participants through Day 14. The number of participants included in the analyses covering the 28-day follow-up is shown in Tables 2 and 3 . ITT=intention-to-treat; mITT=modified intention-to-treat; PP=per protocol; (1) Participant on chronic inhaled corticosteroid therapy (exclusion criteria) (2) Participants who have not been lost to follow-up before Day-9 and have not completed the 10-day treatment for reasons other than the occurrence of an adverse event. (3) Patients lost to follow-up were excluded from the ITT analysis (4) Reasons: lost to follow-up, n=2 ; major of eligibility criteria, n=2 (untreated diabetes, n=1; patient requiring oxygen therapy before randomisation, n=1) (5) Reasons: lost to follow-up, n=4 ; major violation..
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