Covid-19 Living Data

Trial NCT04356495, EudraCT 2020-001435-27
Publication COVERAGE - Duvignaud A, Clin Microbiol Infect (2022) (published paper)
Dates: 2020-12-29 to 2021-07-23
Funding: Public/non profit (French Ministry of Health, French National Research Agency, University of Bordeaux, Inserm/REACTing)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / France Follow-up duration (days): 28
Inclusion criteria	Age ≥60 years regardless of the presence of other risk factors, or ≥50 years with at least one of the following risk factors: high blood pressure, body mass index ≥30 kg/m2, diabetes, ischemic heart disease, heart failure, history of stroke, chronic obstructive pulmonary disease, stage ≥3 chronic kidney disease, solid or haematological malignancy diagnosed <5 years ago, immunosuppressive therapy, or HIV infection with CD4 <200/mm3) COVID-19 with first symptoms ≤7 days before positive SARS-CoV-2 nasopharyngeal RT-PCR or antigen test no criteria for hospitalisation or acute oxygen therapy written informed consent.
Exclusion criteria	inability to understand or decide on participation lack of health insurance chronic inhaled corticosteroid therapy hypersensitivity to ciclesonide history of incompletely treated pulmonary tuberculosis pulmonary fungal infection inability to use the inhalation chamber and ongoing treatment with a potent CYP3A4 inhibitor.
Interventions
	Treatment Ciclesonide 2 puffs (160 mcg each) by inhalation twice a day for 10 days
	Control Standard care vitamin supplementation (AZINC vitality®, 2 pills per day) for 10 days
Participants
	Randomized participants : Ciclesonide=110 Standard care=107
	Characteristics of participants N= 217 Mean age : NR 106 males Severity : Mild: n= 217/ Asymptomatic: n=0 Number of vaccinated participants: 16
Primary outcome
	In the register 1) Proportion of participants who had a Grade 3 or 4 adverse event [ Time Frame: From inclusion (day0) to day 14 ]; 2) Efficacy phase: Death [ Time Frame: From inclusion (day0) to day 14 ], Efficacy phase: oxygen therapy [ Time Frame: From inclusion (day0) to day 14 ], Efficacy phase: hospitalization [ Time Frame: From inclusion (day0) to day 14 ]
	In the report 1) occurrence of grade 3-4-5 adverse events; 2) combination of hospitalisation, need for COVID19-related oxygen therapy at home or death
Documents available	Protocol Yes. In English Statistical plan Yes 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, statistical analysis plan, supplementary appendices and study registry were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. The study (n = 217) did not achieve its target sample size (n = 702) because recruitment was terminated after futility was determined in a pre-planned interim analysis. This study was updated on September 1st, 2022 with data extracted after contact with authors.