Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE)
et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2022.02.031, NCT04356495, Mar 2022
Budesonide for COVID-19
20th treatment shown to reduce risk in
April 2021, now with p = 0.0000011 from 15 studies, recognized in 10 countries.
No treatment is 100% effective. Protocols
combine treatments.
6,200+ studies for
200+ treatments. c19early.org
|
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.
Targeted administration to the respiratory tract provides treatment directly
to the typical source of initial SARS-CoV-2 infection and replication, and
allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
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.
|
| 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, study period 29 July, 2020 - 22 October, 2021, average treatment delay 4.0 days, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04356495 (history).
Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE)
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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