Table 2.
Primary outcome of respiratory symptom resolution in Canadian adults with laboratory confirmed covid-19 presenting with fever, cough, or dyspnoea by treatment assignment. Values are numbers (percentages) unless stated otherwise
| Outcomes | Placebo* (n=98) | Ciclesonide† (n=105) | Adjusted risk difference‡, % (95% CI) |
|---|---|---|---|
| Primary outcome on day 7§ | |||
| Modified intention to treat | 34 (35) | 42 (40) | 5.5 (−7.8 to 18.8) |
| Per protocol | 32 (35); (n=91) | 38 (38); (n=99) | 3.4 (−10.4 to 17.1) |
| Secondary outcomes | |||
| Primary outcome on day 14 | 57 (58) | 69 (66) | 7.5 (−5.9 to 20.8) |
| Overall feeling of improvement: | |||
| Day 7 | 74 (76) | 77 (73) | −2.1 (−14.2 to 9.9) |
| Day 14 | 91 (93) | 95 (90) | −2.4 (−10.0 to 5.1) |
| Resolution of symptoms: | |||
| Day 7 | 22 (22) | 25 (24) | 0.8 (−10.6 to 12.2) |
| Day 14 | 44 (45) | 57 (54) | 9.1 (−4.6 to 22.8) |
| Admission to hospital: day 14 | 3 (3) | 6 (6) | 2.3 (−3.0 to 7.6) |
| Mortality: | |||
| Day 14 | 0 (0) | 0 (0) | – |
| Day 29 | 0 (0) | 0 (0) | – |
| Improvement in cough¶: | (n=86) | (n=89) | |
| Day 7 | 54 (63) | 57 (64) | 1.2 (−12.9 to 15.3) |
| Day 14 | 72 (84) | 74 (83) | −0.9 (−11.9 to 10.1) |
| Resolution of dyspnoea**: | (n=49) | (n=53) | |
| Day 7 | 27 (55) | 38 (71) | 15.8 (−2.4 to 34.0) |
| Day 14 | 40 (82) | 45 (85) | 3.9 (−10.7 to 18.5) |
Data represent patients from modified intention-to-treat population (those who took at least one dose of study drug and completed at least one follow-up questionnaire related to symptom resolution compared with baseline).
Metered dose inhaler and nasal saline placebo.
Inhaled and intranasal.
Adjusted for stratification on sex.
Resolution of fever and all respiratory symptoms by day 7.
Analysis limited to patients who reported dry or wet cough at baseline.
Dyspnoea defined as shortness of breath, chest tightness, or chest congestion. Analysis limited to participants who reported dyspnoea at baseline.