Trial NCT04377711
Publication Clemency B, JAMA Intern Med, 2021 (published paper)
Dates: 2020-06-11 to 2020-11-03
Funding: Private (Covis Pharma GmbH; National Center for Advancing Translational Sciences of the National Institutes of Health (NIH); National Heart, Lung, and Blood Institute of the NIH)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / USA Follow-up duration (days): 60 | |
| Inclusion criteria | At least age 12 years; Had a positive SARS-CoV-2 molecular or antigen diagnostic sample obtained during the previous 72 hours; Were not hospitalized or under consideration for hospitalization; had an oxygen saturation level of at least 93% on room air; Were able to demonstrate successful use of an MDI; Had at least 1 of the following symptoms of COVID-19: fever, cough, or dyspnea |
| Exclusion criteria | History of hypersensitivity to ciclesonide; Had taken an inhaled or intranasal corticosteroid within 14 days; had taken oral corticosteroids within 90 days; Had participated in any other clinical trial or used any investigational agent within 30 days; Had a history of cystic fibrosis; Had a history of idiopathic pulmonary fibrosis; Receiving treatment with hydroxychloroquine/chloroquine; Pregnant |
| Interventions | |
| Treatment
Ciclesonide Two inhalations of 160 mcg twice a day for 30 days |
|
| Control
Standard Care ( / ) | |
| Participants | |
| Randomized 400 participants (n1=197 / n2= 203) | |
| Characteristics of participants N=400 Mean age : 43.3 179 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Time to alleviation of COVID-19-related symptoms by Day 30 [ Time Frame: Day 30 ] | |
| In the report Time to alleviation of all COVID-19–related symptoms (cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell) by day 30 | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment |
In addition to the published article, the pre-print, the trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. The primary outcome in the article reflects that in the registry/protocol. The primary outcome was changed prior to start of recruitment from emergency department visits or hospital admission to symptom resolution. The study achieved its target sample size.
This study was updated on the 15th of December, 2021 with data from the published article. |