Table 1.
Characteristics of Cardiovascular Clinical Trials Initiated Before and During COVID‐19
| Characteristic | Cardiovascular Trials Initiated Before COVID‐19 (n=892) | COVID‐19 Trials With a Cardiovascular Focus (n=25) | P Value* |
|---|---|---|---|
| Phase of trial, n (%) | 0.005 | ||
| I | 51 (5.7) | 2 (8.0) | |
| II | 102 (11.4) | 14 (56.0) | |
| III | 103 (11.5) | 4 (16.0) | |
| IV | 85 (9.5) | 1 (4.0) | |
| Not available | 551 (61.8) | 4 (16.0) | |
| Target enrollment (median, 25th–75th percentile) | 100 (40–359) | 200 (70–626) | 0.15 |
| Time from trial initiation (median, 25th–75th percentile) | 846 (441–1563) | 27 (18–34) | <0.001 |
| Anticipated time until trial completion (median, 25th–75th percentile) | 414 (171–932] | 232 (180–323) | 0.014 |
| Source of funding, n (%) | 0.002 | ||
| Industry | 330 (37.0) | 2 (8.0) | |
| Federal | 141 (15.8) | 2 (8.0) | |
| Both | 13 (1.5) | 0 (0.0) | |
| Other† | 408 (45.7) | 21 (84.0) | |
| States with the highest number of trials (COVID‐19 cases per state) | |||
| State 1 | California: 293 (73 218) | New York: 6 (345 828) | |
| State 2 | New York: 263 (345 828) | California: 5 (73 218) | |
| State 3 | Pennsylvania: 245 (62 194) | North Carolina: 3 (15 850) | |
| Cardiovascular trial field(s), n (%)‡ | |||
| Heart failure | 260 (29.1%) | … | |
| Electrophysiology | 223 (25.0%) | … | |
| Interventional | 160 (17.9%) | … | |
| Pediatric or congenital | 81 (9.1 %) | … | |
| General | 67 (7.5 %) | … | |
| COVID‐19 trial with cardiovascular patient population, n (%) | … | 7 (28.0%) | |
| COVID‐19 trial with any cardiovascular intervention, n (%) | … | 13 (52.0%) | |
| COVID‐19 trial with RAAS active agent, n (%) | … | 6 (24.0%) | |
| COVID‐19 trial with any cardiovascular outcome, n (%) | … | 16 (64.0%) | |
| COVID‐19 trial with biomarker outcome, n (%) | … | 8 (32.0%) | |
Data are in reference to May 13, 2020. COVID‐19 indicates coronavirus disease 2019; RAAS, renin‐angiotensin‐aldosterone system.
*
P values shown for chi‐square and Wilcoxon rank‐sum tests, as appropriate.
†
Other funders include individuals, universities, and community‐based organizations.
‡
The 5 most frequent fields classified by investigators are listed (remaining categories include critical care, genetics, imaging, cardio‐oncology, pulmonary hypertension, prevention, cardiac surgery, and other). Each clinical trial was categorized in up to 2 fields.