Table 1.
Randomised controlled trials that examined inhaled corticosteroids for outpatient treatment of COVID-19
| Exposure | Timing of exposure | Total patients | Age, years* | Sex, % | Primary outcome | Inhaled corticosteroid group | Control group | Between-group difference, p value | |
|---|---|---|---|---|---|---|---|---|---|
| Ramakrishnan et al (2021);134 STOIC (open-label) | Inhaled budesonide (1600 μg/day) until self-reported symptom recovery or primary outcome achievement | ≤7 days from symptom onset | 146 | 45 (13) | 57% female, 43% male | Combined endpoint of COVID-19-related emergency department assessment or hospital admission | Two (3%) of 73 patients | 11 (15%) of 73 patients | Difference in proportions 12·3% (95% CI 3·3 to 21·3); p=0·009 |
| Yu et al (2021);135 PRINCIPLE (open-label) | Inhaled budesonide (1600 μg/day) for 14 days | ≤14 days from symptom onset | 1856 | 64·2 (7·6)† | 52% female, 48% male† | Time to first self-reported recovery by 28 days; combined endpoint of hospital admission or death by 28 days | 11·8 days (95% BCI 10·0 to 14·1); 6·8% (95% BCI 4·1 to 10·2) | 14·7 days (95% BCI 12·3 to 18·0); 8·8% (95% BCI 5·5 to 12·7) | HR 1·21 (95% BCI 1·08 to 1·36); HR 0·75 (95% BCI 0·55 to 1·03) |
| Ezer et al (2021);136 CONTAIN (placebo-controlled) | Inhaled (1200 μg/day) and intranasal (200 μg/day) ciclesonide for 14 days | ≤6 days from symptom onset | 203 | 35 (27–47) | 54% female, 46% male | Resolution of symptoms by day 7 | 42 (40%) of 105 patients | 34 (35%) of 98 patients | Adjusted risk difference 5·5% (95% CI −7·8 to 18·8), p=NS‡ |
| Clemency et al (2022);137 Covis Pharma (placebo-controlled) | Inhaled ciclesonide (640 μg/day) for 30 days | Positive SARS-CoV-2 test ≤72 h | 400 | 43·3 (16·9) | 55% female, 45% male | Time to alleviation of COVID-19-related symptoms by day 30 | 19·0 days (95% CI 14·0 to 21·0) | 19·0 days (95% CI 16·0 to 23·0) | HR 1·08 (95% CI 0·84 to 1·38), p=NS‡ |
| Duvignaud et al (2022);138 COVERAGE (open-label) | Inhaled ciclesonide (640 μg/day) for 10 days | ≤7 days from symptom onset | 217 | 63 (59–68) | 51% female, 49% male | Combined endpoint of hospital admission, oxygen therapy at home, or death by day 14 | 18 (16%) of 110 patients | 13 (12%) of 107 patients | p=NS§ |
BCI=Bayesian credible interval. HR=hazard ratio. NS=not significant.
*
Data are mean (SD) or median (IQR).
†
Data refer to SARS-CoV-2-positive participants.
‡
Significance threshold was 0·05.
§
Significance threshold was not specified.