Covid-19 Living Data

Trial NCT04435795
Publication CONTAIN - Ezer N, BMJ (2021) (published paper)
Dates: 2020-09-15 to 2021-06-08
Funding: Mixed (McGill University Health Centre Foundation and the McGill Interdisciplinary Initiative in Infection and Immunity. The placebo metered dose inhaler was donated by GlaxoSmithKline. Nasal saline, and spacers for the inhalers were purchased by NE. The study drug was donated by COVIS Pharma. )
Conflict of interest: Yes

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Canada Follow-up duration (days): 29
Inclusion criteria	Adults Aged 18 years and older Had polymerase chain reaction confirmed covid-19 at enrolment At least one of the symptoms of fever, cough (wet or dry), or shortness of breath (including dyspnoea, chest congestion, or chest tightness as synonyms)
Exclusion criteria	Already on inhaled corticosteroid medication Currently using systemic steroids (oral or intravenous or intramuscular such as Prednisone) or use of steroids 7 days prior to enrolment Severely ill patients at enrollment (i.e., admitted to ICU at admission) Unable to self-administer the inhaler Known or suspected pregnancy and breastfeeding Known allergy to study medication or its components (non-medicinal ingredients including lactose allergy (type I)) Patients with untreated fungal, bacterial, or tubercular infections of the respiratory tract Current hospitalization Current use of oxygen at home or in the hospital Receipt of a COVID vaccine.
Interventions
	Treatment Ciclesonide 600 mcg inhaled twice a day + 200 mcg intranasally once a day for 14 days
	Control Placebo
Participants
	Randomized participants : Ciclesonide=108 Placebo=107
	Characteristics of participants N= 215 Mean age : NR 94 males Severity : Mild: n= 203/ Asymptomatic: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register Proportion of participants with no symptoms of cough, fever or dyspnea [ Time Frame: day 7 ]
	In the report Resolution of self-reported fever and all respiratory symptoms at day 7 of treatment. Respiratory symptoms included cough (wet or dry) or dyspnoea (which included the description of shortness of breath, chest congestion, or chest tightness as synonyms).
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: 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 protocol, the statistical analysis plan, the supplementary and the study registry were used in data extraction and risk of bias assessment. The study (n=215) did not achieve the target sample size (n=318) and was terminated early for expected futility to meet total enrolment. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Adverse events were reported in the paper but were not specified in the registry. This study was updated on March 16th, 2022 with data extracted after contact with authors.