Duvignaud: Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE) [Budesonide]

Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE)

Duvignaud et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2022.02.031, NCT04356495 (history)

Duvignaud et al., Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised.., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2022.02.031, NCT04356495

Mar 2022 Source PDF

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Early terminated RCT with 110 ciclesonide patients and 107 patients treated with vitamins A, B1, B2, B3, B5, B6, B8, B9, B12, C, D3, and E, calcium, chromium, copper, iron, manganese, molybdenum, selenium, and zinc (Azinc Vitality), showing no significant differences between the two treatments. There was no control group. NCT04356495 (history). EudraCT 2020-001435-27. This study is excluded in meta analysis: study compares against another treatment showing significant efficacy.

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risk of death, 80.2% lower, RR 0.20, p = 0.24, treatment 0 of 110 (0.0%), control 2 of 107 (1.9%), NNT 54, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 28.

risk of death, 67.0% lower, RR 0.33, p = 0.49, treatment 0 of 110 (0.0%), control 1 of 107 (0.9%), NNT 107, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 14.

risk of hospitalization, 36.2% higher, RR 1.36, p = 0.52, treatment 14 of 110 (12.7%), control 10 of 107 (9.3%), day 28.

risk of hospitalization, 29.7% higher, RR 1.30, p = 0.65, treatment 12 of 110 (10.9%), control 9 of 107 (8.4%), day 14.

risk of progression, 19.7% higher, RR 1.20, p = 0.69, treatment 16 of 110 (14.5%), control 13 of 107 (12.1%), oxygen, hospitalization, or death, day 28.

risk of progression, 13.5% higher, RR 1.13, p = 0.84, treatment 14 of 110 (12.7%), control 12 of 107 (11.2%), oxygen, hospitalization, or death, day 14, primary outcome.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Duvignaud et al., 16 Mar 2022, Randomized Controlled Trial, France, peer-reviewed, median age 63.0, 314 authors, average treatment delay 4.0 days, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04356495 (history).

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Abstract: Journal Pre-proof 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, the Coverage Study Group, SA1-1: Members of the COVERAGE France Study Group. Sponsor (CHU Bordeaux), National Trial Coordination Unit: CIC-EC 1401/ EUCLID, MEREVA, National Coordinating Pharmacy, National Coordinating Laboratories, Bordeaux, Créteil, Bordeaux Study center, Investigating physicians, Coordination, Dijon Study center, Investigating physicians, Coordination, Nancy Study center: Investigating physicians, Coordination, Toulouse Study sites, Investigating physicians, Coordination, Bastia Study center, Investigating physicians, Coordination, Montpellier Study center: Investigating physicians, Coordination, Paris Study center 1: Collège National des Généralistes Enseignants (CNGE), Investigating physicians, Coordination, Paris Study center 2, Groupe Hospitalier Paris Saint Joseph (GHPSJ), Investigating physicians, Coordination, Paris Study center 3: Institut de Médecine et d’Epidémiologie Appliquée (IMEA), Coordination, Nantes/Angers Study center, Investigating physicians, Coordination, Others contributors, Scientific Advisory Board: Voting members, Non-voting members, Data Safety Monitoring Board PII: S1198-743X(22)00108-2 DOI: https://doi.org/10.1016/j.cmi.2022.02.031 Reference: CMI 2858 To appear in: Clinical Microbiology and Infection Received Date: 1 November 2021 Revised Date: 8 February 2022 Accepted Date: 20 February 2022 Please cite this article as: Duvignaud A, Lhomme E, Onaisi R, Sitta R, Gelley A, Chastang J, Piroth L, Binquet C, Dupouy J, Makinson A, Lefèvre B, Naccache J-M, Roussillon C, Landman R, Wallet C, Karcher S, Journot V, Nguyen D, Pistone T, Bouchet S, Lafon M-E, Molimard M, Thiébaut R, de Lamballerie X, Joseph J-P, Richert L, Saint-Lary O, Djabarouti S, Wittkop L, Anglaret X, Malvy D, the Coverage Study Group, SA1-1: Members of the COVERAGE France Study Group. Sponsor (CHU Bordeaux), SA1-1: Members of the COVERAGE France Study Group. Sponsor (CHU Bordeaux), Duluc G, Arma D, Beaufrère P, Belcastro J, Brice T, Cassai P, Desjardins S, Durrieu J, Georgevail S, Gimbert A, Marchi S, Marty V, Nacka F, Pinilla R, Poulizac P, Regueme S, Rousset M, Roussillon C, Salvo F, Soria J, Vautrat S, National Trial Coordination Unit: CIC-EC 1401/EUCLID, MEREVA, National Coordinating Pharmacy, National Coordinating Laboratories, Bordeaux, Bordeaux, Pellegrin I, Bouchet S, Cognet C, Garrigue I, Jeanpetit J, Lafon M-E, Pouzet A, Tarricone A, Trimoulet P, Voldoire A, Créteil, Bordeaux Study center, Investigating physicians, Investigating physicians, Anglaret X, Duvignaud A, Bez C, Bironneau E, Collomb E, Contamin A, Dubourdieu C, Faure N, Galinski M, Gibaud P, GilJardine C, Guillot-Warin J, Lebouc C, Leger A, Lengline V, Loizeau C, Mayenc M, Merle N, NadiriKahraman H, Nguyen D, Odorico M, Onaisi R, Pistone T, Sacher F, Scandella J, Velardo F, Wiet..

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