Table 3.
Long term follow-up: Primary and secondary outcomes.
| Ivermectin |
Usual Care |
Estimated treatment effect [95% CI] | P-value | |
|---|---|---|---|---|
| (N = 2157) | (N = 1806) | |||
| Primary outcome: | ||||
| Feeling fully recovereda, n/N(%) | ||||
| 3 months | 1265/1766 (71.6%) | 993/1486 (66.8%) | 1·06 [1·03 to 1·10] | 0·0002 |
| 6 monthsb | 1301/1750 (74.3%) | 1037/1455 (71.3%) | 1·05 [1·02 to 1·08] | 0·0035 |
| 12 months | 1431/1848 (77.4%) | 1113/1533 (72.6%) | 1·06 [1·03 to 1·09] | 0·0001 |
| Primary outcome: sensitivity analysis | (N = 2250) | (N = 1869) | ||
| Feeling fully recovereda, n/N(%) | ||||
| 3 months | 1267/1769 (71.6%) | 996/1490 (66.8%) | 1·06 [1·03 to 1·09] | 0·0002 |
| 6 monthsb | 1304/1753 (74.4%) | 1042/1461 (71.3%) | 1·05 [1·01 to 1·08] | 0·0039 |
| 12 months | 1436/1853 (77.5%) | 1120/1540 (72.7%) | 1·06 [1·03 to 1·09] | 0·0001 |
| Secondary outcomes: | ||||
| Number of unwell days in the past 2 weeksc, mean (SD) [n] | ||||
| 3 months | 10.5 (4·4) [501] | 10.2 (4·5) [493] | 0·19 [−0·38 to 0·77] | 0·51 |
| 6 months | 10.3 (4·7) [449] | 9.9 (4·7) [418] | 0·34 [−0·26 to 0·95] | 0·27 |
| 12 months | 9.6 (5·0) [417] | 9.1 (5·0) [420] | 0·42 [−0·20 to 1·03] | 0·18 |
| Rating of how well participant feels on day of completion (1 worst, 10 best)d, mean (SD) [n] | ||||
| 3 months | 8·2 (1·6) [1765] | 8·0 (1·7) [1486] | 0·18 [0·07 to 0·29] | 0·0017 |
| 6 months | 8·0 (1·7) [1750] | 7·8 (1·8) [1455] | 0·15 [0·04 to 0·27] | 0·0081 |
| 12 months | 7·9 (1·8) [1847] | 7·7 (1·7) [1533] | 0·14 [0·03 to 0·25] | 0·0145 |
| Well-being (WHO-5)d, mean (SD) [n] | ||||
| 3 months | 62·1 (22·3) [1765] | 59·5 (22·5) [1485] | 2·49 [1·20 to 3·79] | 0·0002 |
| 6 months | 61·3 (22·4) [1750] | 58·9 (22·8) [1455] | 2·33 [1·03 to 3·63] | 0·0005 |
| 12 months | 61·6 (22·4) [1845] | 59·3 (22·5) [1533] | 2·41 [1·13 to 3·69] | 0·0002 |
| Ongoing persistent COVID-19 symptoms at 3, 6 and 12 monthse,f, n/N (%) | 94/1941 (4·8%) | 109/1624 (6·7%) | 0·72 [0·55 to 0·94] | 0·0153 |
| Impact of COVID-19 on work/studies,h n/N (%) and median (IQR) [n] | ||||
| Stopping work/studiesf | 149/1998 (7.5%) | 134/1671 (8.0%) | 0·92 [0·73 to 1·14] | 0·44 |
| Having time off work/studyingf | 322/1998 (16.1%) | 267/1671 (16.0%) | 0·98 [0·85 to 1·14] | 0·83 |
| Total time off work/studying (days)g | 14 (7 to 34) [322] | 15 (7 to 35) [266] | -1·43 [−5·06 to 2·20] | 0·44 |
| Change job/studies | 116/1998 (5.8%) | 87/1671 (5.2%) | 1.10 [0.84 to 1.43] | 0.50 |
| Healthcare service utilisationh, n/N (%) and median (IQR) [n] | ||||
| Any contactf | 430/1998 (21.5%) | 375/1671 (22.4%) | 0·95 [0·84 to 1·07] | 0·42 |
| Number of contacts | 4 (2 to 7) [429] | 4 (2 to 8) [375] | – | – |
Ivermectin versus concurrent and eligible usual care.
Relative risks (RR), derived from frequentist approach mixed effect logistic regression model, adjusted for assessment time point, age, presence of comorbidity, duration of illness at randomisation, vaccination status, and an interaction between randomised group and assessment time point as fixed effects, and participant as a random effect. RR < 1 favours ivermectin. P < 0.05 indicates statistical significance.
Long term follow-up primary outcome.
Number of unwell days in the past 2 weeks, if participant reported partial or no recovery from their original COVID-19 illness (range from 0 to 14 days). Estimated mean difference, derived from frequentist approach linear mixed model adjusted for randomised group, assessment time point, age, presence of comorbidity, duration of illness at randomisation, vaccination status, baseline score (if applicable), and an interaction between randomised group and assessment time point as fixed effects, and participant as a random effect. Mean difference < 0 favours ivermectin. P < 0.05 indicates statistical significance.
Mean difference, derived from frequentist approach linear mixed model adjusted for randomised group, assessment time point, age, presence of comorbidity, duration of illness at randomisation, vaccination status, baseline score (if applicable), and an interaction between randomised group and assessment time point as fixed effects, and participant as a random effect. Mean difference > 0 favours ivermectin. P < 0.05 indicates statistical significance.
Pre-specified long COVID-19 symptoms (feverish, cough, shortness of breath, chest pain, loss of smell, loss of taste, nausea/vomiting, diarrhoea, headache, muscle ache, generally unwell and fatigue), defined as participants reporting the same symptoms, severity, and relatedness in all 3 timepoints.
Relative risks, derived from frequentist approach mixed effect logistic regression model, adjusted for assessment time point, age, presence of comorbidity, duration of illness at randomisation, vaccination status, and an interaction between randomised group and assessment time point as fixed effects, and participant as a random effect. RR < 1 favours ivermectin. P < 0.05 indicates statistical significance.
Median difference, derived from quintile regression adjusted for randomised group, age, presence of comorbidity, duration of illness at randomisation, and vaccination status. Median difference < 0 favours ivermectin. P < 0.05 indicates statistical significance.
Assessed at 12 months, healthcare service utilisation from 28 days after randomisation.