NCT04356495.

Study name	Trial of COVID‐19 outpatient treatment in individuals with risk factors for aggravation (COVERAGEFrance)
Methods	Trial design: multicentre, open‐label, RCT Sample size: 820 Setting: outpatient Language: English Number of centres: 11 centres Type of intervention: treatment
Participants	Inclusion criteria: clinical picture suggestive of COVID‐19 dated ≤ 7 days positivity test proving an acute SARS‐CoV‐2 infection, according to current recommendations absence of criteria for hospitalisation or oxygen therapy according to current recommendations age: ≥ 60 years with no risk factors 50–59 years and the presence of ≥ 1 of following risk factors: arterial hypertension under treatment (all stages) obesity (BMI ≥ 30 kg/m2) diabetes under treatment (all types) ischaemic heart disease (all stages) heart failure (all stages) stroke history chronic obstructive pulmonary disease (all stages) stage 3 chronic renal failure (30 ≤ estimated GFR < 60 mL/minute/1.73 m²) malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed < 5 years ago immunodeficiency of therapeutic origin (solid organ transplant or haematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids > 15 mg/day of prednisone equivalent taken for ≥ 2 months) HIV infection with CD4 < 200/mm3 valid, ambulatory person, fully able to understand the issues of the trial beneficiary of a social security scheme signed informed consent Exclusion criteria: asymptomatic person inability to make a decision to participate (dementia, person under legal protection, curatorship, or guardianship) ongoing illness or chronic treatment contraindicated by taking 1 of the trial drugs
Interventions	Intervention group: inhaled ciclesonide 160 µg (2 puffs twice a day) for 10 days Control group: vitamin supplement ("AZINC forme et vitalité"), 2 tablets daily for 10 days Concomitant therapy: no
Outcomes	Primary outcomes: Pilot phase: proportion of participants who had a grade 3 or 4 adverse event from inclusion (day 0) to day 14 Efficacy phase: death from inclusion (day 0) to day 14; proportion of participants with an occurrence of death Efficacy phase: oxygen therapy from inclusion (day 0) to day 14; proportion of participants who had an indication for oxygen therapy Efficacy phase: hospitalisation from inclusion (day 0) to day 14; proportion of participants who had an indication for hospitalisation Secondary outcomes: proportion of hospitalisations, overall and by cause from inclusion (day 0) to day 28; death and causes of death from inclusion (day 0) to day 28; proportion of intensive care hospitalisations, overall and by cause from inclusion (day 0) to day 28; proportion of participants with negative SARS‐CoV‐2 RT‐PCR at day 7; haematological markers (white blood count, prothrombin level, INR) evolution from inclusion (day 0) to day 7; inflammatory markers evolution (PCT, CRP) from inclusion (day 0) to day 7; number and proportion of grade 1, 2, 3, 4 adverse events from inclusion (day 0) to day 28; number and proportion of grade 1, 2, 3, 4 adverse reactions from inclusion (day 0) to day 28; acceptability of treatment assessed by interview from inclusion (day 0) to day 10; proportion of participants who received ≥ 1 day of antibiotic therapy from inclusion (day 0) to day 28; proportion of participants who experienced a worsening of oxygen saturation from inclusion (day 0) to day 28; proportion of participants who completed the prescribed protocol treatment from inclusion (day 0) to day 10
Starting date	29 July 2020
Contact information	Denis MALVY, denis.malvy@chu‐bordeaux.fr Xavier ANGLARET, xavier.anglaret@u‐bordeaux.fr
Notes	Recruitment status: recruiting Prospective completion date: 29 January 2022 Date last update was posted: 3 August 2021 Sponsor/funding: University Hospital, Bordeaux, France