Characteristics | COVID‐19 trials | COVID‐19‐related trials | Overall |
---|---|---|---|
Total number of trials | 56 | 12 | 68 |
Total participants across trials | 33 757 | 2586 | 36 343 |
Participants per trial | |||
Median (IQR) | 150 (33–395) | 147 (94–280) | 150 (37–395) |
Mean (SD) | 625 (1507) | 215 (184) | 551 (1374) |
Trial status | |||
Not yet recruiting | 24 (43%) | 9 (75%) | 33 (49%) |
Recruiting | 26 (46%) | 3 (25%) | 29 (43%) |
Completed | 4 (7%) | 0 | 4 (5.9%) |
Withdrawn | 2 (4%) | 0 | 2 (2.9%) |
Trial phase* | |||
Phase 0 | 1/55 (2%) | 0 | 1 (1%) |
Phase 1 | 19/55 (35%) | 1 (8%) | 20 (30%) |
Phase 2 | 5/55 (9%) | 0 (0%) | 5 (7%) |
Phase 3 | 14/55 (25%) | 0 (0%) | 14 (21%) |
Phase 4 | 2/55 (4%) | 0 (0%) | 2 (3%) |
Not applicable (eg, not a drug trial) | 14/55 (25%) | 11 (92%) | 25 (37%) |
Recruitment country | |||
Australia only | 46 (82%) | 11 (92%) | 57 (84%) |
International (Australia and other country/countries) | 10 (18%) | 1 (8%) | 11 (16%) |
Purpose* | |||
Treatment, drug | 24/55 (44%) | 0 | 24 (36%) |
Treatment, other | 10/55 (18%) | 9 (75%) | 19 (28%) |
Prevention, vaccine† | 8/55 (14%) | 0 | 8 (12%) |
Prevention, other | 11/55 (20%) | 2 (17%) | 13 (19%) |
Other (eg, diagnosis, education) | 2/55 (4%) | 1 (8%) | 3 (5%) |
Included population | |||
Confirmed COVID‐19 | 34 (61%) | 1 (8%) | 35 (51%) |
Healthy volunteers | 14 (25%) | 3 (25%) | 17 (25%) |
Health care professional | 6 (11%) | 2 (17%) | 8 (12%) |
Individuals at high risk of poor outcomes | 2 (4%) | 6 (50%) | 8 (12%) |
Population age | |||
Adult (18–65 years) | 9 (16%) | 1 (8%) | 10 (15%) |
Older adult (age > 65 years) | 2 (4%) | 1 (8%) | 3 (4%) |
All ages | 45 (80%) | 10 (83%) | 55 (81%) |
Any blinding (personnel or participant)* | |||
Yes | 19/49 (37%) | 3/8 (38%) | 22 (37%) |
No | 30/49 (63%) | 5/8 (62%) | 38 (63%) |
Randomisation* | |||
Randomised controlled trial | 44/54 (81%) | 7 (58%) | 51 (77%) |
Non‐randomised trial | 10/54 (19%) | 5 (42%) | 15 (23%) |
Trials using digital health solutions | |||
Yes | 5 (9%) | 12 (100%) | 17 (25%) |
No | 51 (91%) | 0 | 51 (75%) |
Commercial involvement (sponsorship, collaboration or funding) | |||
No commercial involvement | 40 (71%) | 9 (75%) | 49 (72%) |
Commercial involvement | 16 (29%) | 3 (25%) | 19 (28%) |
Population with comorbidity | |||
Yes | 7 (12%) | 2 (17%) | 9 (13%) |
No | 49 (88%) | 10 (83%) | 58 (87%) |
IQR = interquartile range; SD = standard deviation.
No information available for one trial for trial phase and purpose, for seven trials for blinding (optional registration field), and for two trials for study design for COVID‐19 trials. For COVID‐19‐related trials, no information was available for four trials for blinding (optional registration field). These trials were excluded from the analysis for these characteristics. One trial with a sample size of 30 000 was excluded from the sample size analyses.
Two vaccine clinical trials registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) were recorded as “treatment” for the “purpose of the study” field.