Table 1.
Summary of chemoprophylaxis study design features
| Trial characteristics | Number of trials (%), n = 76 | Number proposed to be enrolled (%); total, 208,367 | Median (IQR) | ||
|---|---|---|---|---|---|
| Design and intervention | Randomisation | ||||
| Randomised | Total | 63(83) | 197,010 (95) | 600 (236–1834) | |
| Cluster randomised | 8(11) | 12,710 (6) | 1575 (1050–2075) | ||
| Non-randomised | 13 (17) | 11,357 (5) | 400 (300–1000) | ||
| Approach | |||||
| PrEP | 55(72) | 180,848 (87) | 440 (203–1500) | ||
| PEP | 21(28) | 27,519 (13) | 1000 (400–2000) | ||
| Blinding | |||||
| Single-blinded | 10 (13) | ||||
| Double-blinded† | 36(47) | ||||
| Open-label | 28 (37) | ||||
| Not stated | 2 (3) | ||||
| Estimated sample size (N) | |||||
| ≤ 299 | 18 (24) | ||||
| 300–499 | 20(26) | ||||
| 500–999 | 7 (9) | ||||
| 1000–4999 | 26 (34) | ||||
| 5000+ | 5 (7) | ||||
| Agent | |||||
| “Western” pharmaceutical agents | 67 (88) | ||||
| TCM/ayurvedic | 9(12) | ||||
| Population | HCW | 49 (64) | 160,398 (77) | 450 (350–1212) | |
| Close contacts of COVID-19 patients | 11 (14) | 11,326 (5) | 600 (293–1410) | ||
| Both HCW and close contacts | 5 (7) | 9625 (5) | 2000 (1739–2486) | ||
| Older adults (65+ years) | 3 (4) | 2736 (1) | 600 (403–1265) | ||
| General population | 2 (3) | 22,000 (11) | 11,000 (6500–15,500) | ||
| Children (1–18 years) | 1 (1) | 200 (<1) | N/A | ||
| Other/unspecified (includes cancer, transplant and haemodialysis patients, cardiovascular/respiratory co-morbidities) | 5 (7) | 2132 (1) | 200 (132–200) | ||
†Also includes variants reporting higher levels of blinding