Table 2.
Clinical Trials for COVID-19 Treatment Options: Pregnancy, Lactation, and Contraception Requirement Criteria by Sponsor, Location, and Phase (n = 495)
| Pregnancy Exclusion |
Lactation Exclusion |
Contraception Requirement |
||||
|---|---|---|---|---|---|---|
| n (%) | p Value | n (%) | p Value | n (%) | p Value | |
| Sponsor | ||||||
| Nonpharmaceutical | 299 (69.4) | .09 | 228 (52.9) | .09 | 66 (15.3) | <.001 |
| Pharmaceutical | 51 (79.7) | 41 (64.1) | 25 (39.1) | |||
| Location∗ | ||||||
| U.S. | 98 (68.1) | .29 | 87 (60.4) | .12 | 30 (20.8) | .25 |
| International | 239 (72.9) | 173 (52.7) | 54 (16.5) | |||
| Phase† | ||||||
| 1 | 40 (71.4) | <.001 | 34 (60.7) | <.001 | 11 (19.6) | .02 |
| 1/2 | 31 (81.6) | 27 (71.1) | 12 (31.6) | |||
| 2 | 126 (75.9) | 104 (62.7) | 36 (21.7) | |||
| 2/3 | 39 (72.2) | 27 (50.0) | 9 (16.7) | |||
| 3 | 72 (69.9) | 49 (47.6) | 18 (17.5) | |||
| 4 | 22 (73.3) | 11 (36.7) | 4 (13.3) | |||
| N/A‡ | 20 (41.7) | 17 (35.4) | 1 (2.1) | |||
∗
Trials that included both U.S. and international locations were excluded for this analysis (n = 23).
†
The p value represents the overall χ2 test.
‡
Trials without phases.