Table 3.
Effect of allocation to higher dose corticosteroid on non-SARS-CoV-2 infection, metabolic complications, new cardiac arrhythmia, thrombotic events, and clinically significant bleeds
| Higher dose steroids (n=659) | Usual care (n=613) | Absolute difference (95% CI) | ||
|---|---|---|---|---|
| Non-SARS-CoV-2 infection | ||||
| Pneumonia | 64 (10%) | 37 (6%) | 3·7% (0·7 to 6·6) | |
| Urinary tract | 12 (2%) | 9 (1%) | 0·4% (−1·0 to 1·7) | |
| Biliary | 0 | 0 | .. | |
| Other intra-abdominal | 0 | 1 (<1%) | −0·2% (−0·5 to 0·2) | |
| Blood stream | 7 (1%) | 3 (<1%) | 0·6% (−0·4 to 1·5) | |
| Skin | 1 (<1%) | 3 (<1%) | −0·3% (−1·0 to 0·3) | |
| Other | 9 (1%) | 13 (2%) | −0·8% (−2·2 to 0·7) | |
| Any non-SARS-CoV-2 infection | 81 (12%) | 58 (9%) | 2·8% (−0·6 to 6·2) | |
| Metabolic complications* | ||||
| Ketoacidosis | 1 (<1%) | 1 (<1%) | 0·0% (−0·4 to 0·4) | |
| Hyperglycaemic hyperosmolar state | 5 (1%) | 2 (<1%) | 0·4% (−0·4 to 1·2) | |
| Other hyperglycaemia requiring new use of insulin | 138 (21%) | 86 (14%) | 6·9% (2·8 to 11·1) | |
| Any clinically significant hyperglycaemia | 142 (22%) | 87 (14%) | 7·4% (3·2 to 11·5) | |
| Severe hypoglycaemia | 2 (<1%) | 2 (<1%) | 0·0% (−0·6 to 0·6) | |
| New cardiac arrhythmia† | 13 (2%) | 8 (1%) | 0·7% (−0·7 to 2·1) | |
| Thrombotic events† | 8 (1%) | 13 (2%) | −0·9% (−2·3 to 0·5) | |
| Clinically significant bleeds† | 8 (1%) | 4 (1%) | 0·6% (−0·5 to 1·6) | |
*
Information on metabolic complications was added to the follow up form on July 28, 2021. Of the 1267 (>99%) randomly assigned participants with a follow-up form completed, 1062 (84%) had information on metabolic complications recorded.
†
Details of these events are presented in the appendix (p 65).