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
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.
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.
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).
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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