Evidence map›Paper›PMID 34728476›Full record

Trial reportBMJ (Clinical research ed.)2021

Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial.

Nicole Ezer, Sara Belga, Nick Daneman, Adrienne Chan, Benjamin M Smith, Shay-Anne Daniels, Kristen Moran, Charlotte Besson, Louisa Y Smyth, Susan J Bartlett and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04435795 (Ciclesonide Clinical Trial for COVID-19 Treatment), which is not on this map. Cited by 50 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 8 pooled it
9.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04435795 phase2 / phase3terminatednot on this map

Ciclesonide Clinical Trial for COVID-19 Treatment

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2020 to 2021Enrolled215ConditionsCOVID 19ArmsNormal Saline intranasal and placebo inhaler, Ciclesonide, Ciclesonide nasal
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 8 syntheses or guidelines pooled it, 74 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Inhaled corticosteroids' effect on COVID-19 patients: A systematic review and meta-analysis of randomized controlled trials.Canadian journal of respiratory therapy : CJRT = Revue canadienne de la therapie respiratoire : RCTR · 2023
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE).Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022
    Trial
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. The Therapy of SARS-CoV-2 Infection in Children.Journal of clinical medicine · 2023
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 3 institutions in 1 country.

Nicole EzerDepartment of Medicine, Division of Respirology, McGill University Health Centre, Montreal, Quebec, Canada nicole.ezer@mcgill.ca.ORCID 0000-0003-1803-6418
Sara BelgaDivision of Infectious Diseases, University of British Columbia, Vancouver, British Columbia, Canada.
Nick DanemanDepartment of Medicine, Division of Infectious Diseases, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Adrienne ChanDepartment of Medicine, Division of Infectious Diseases, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Benjamin M SmithDepartment of Medicine, Division of Respirology, McGill University Health Centre, Montreal, Quebec, Canada.
Shay-Anne DanielsDivision of Infectious Diseases, University of British Columbia, Vancouver, British Columbia, Canada.
Kristen MoranClinical Practice Assessment Unit, Department of Medicine, Montreal, Quebec, Canada.
Charlotte BessonResearch Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
Louisa Y SmythClinical Practice Assessment Unit, Department of Medicine, Montreal, Quebec, Canada.
Susan J BartlettResearch Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
Andrea BenedettiResearch Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
James G MartinDepartment of Medicine, Division of Respirology, McGill University Health Centre, Montreal, Quebec, Canada.
Todd C LeeResearch Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
Emily G McDonaldResearch Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
McGill University Health Centre · CASunnybrook Health Science Centre · CAUniversity of British Columbia · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19.

designRandomised, double blind, placebo controlled trial.

settingThree Canadian provinces (Quebec, Ontario, and British Columbia).

participants203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea.

interventionParticipants were randomised to receive either inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) or metered dose inhaler and nasal saline placebos for 14 days.

main outcome measuresThe primary outcome was symptom resolution at day 7. Analyses were conducted on the modified intention-to-treat population (participants who took at least one dose of study drug and completed one follow-up survey) and adjusted for stratified randomisation by sex.

resultsThe modified intention-to-treat population included 203 participants: 105 were randomly assigned to ciclesonide (excluding two dropouts and one loss to follow-up) and 98 to placebo (excluding three dropouts and six losses to follow-up). The median age was 35 years (interquartile range 27-47 years) and 54% were women. The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval -7.8% to 18.8%). Results might be limited to the population studied, which mainly included younger adults without comorbidities. The trial was stopped early, therefore could have been underpowered.

conclusionCompared with placebo, the combination of inhaled and intranasal ciclesonide did not show a statistically significant increase in resolution of symptoms among healthier young adults with covid-19 presenting with prominent respiratory symptoms. As evidence is insufficient to determine the benefit of inhaled and intranasal corticosteroids in the treatment of covid-19, further research is needed.

trial registrationClinicalTrials.gov NCT04435795.

Indexed as

COVID-19 Drug TreatmentAdministration, InhalationAdolescentAdrenal Cortex HormonesAdultAgedAged, 80 and overAmbulatory CareDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansIntention to Treat AnalysisMaleMiddle AgedAdrenal Cortex HormonesciclesonidePregnenediones

Identifiers

PMID34728476
PMCPMC8561042
OpenAlexW3209822455

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.