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Table 2 Characteristics of primary endpoints in clinical trials with severe patients

From: Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov

  Continuous (N=16) Binary (N=65) Ordinal (N=24) Time-to-event (N=44) Other (N=4)
Time frame
 ≤14 days 3 (18.8%) 12 (18.5%) 6 (25.0%) 3 (6.8%) 1 (25.0%)
 15–30 days 10 (62.5%) 45 (69.2%) 18 (75.0%) 37 (84.1%) 2 (50.0%)
 >30 days 3 (18.8%) 8 (12.3%) 0 (0.0%) 4 (9.1%) 1 (25.0%)
Evaluation of clinical course
 Improvement - 19 (29.2%) - 34 (77.3%) -
 Worsening - 39 (60.0%) - 6 (13.6%) -
 Unknown - 7 (10.8%) - 4 (9.1%) -
Sample size (trials with 1 arma)
  (N=5) (N=10) (N=4) (N=15) (N=1)
 Mean (SD) 101.2 (56.4) 472.3 (407.3) 279.3 (226.1) 335.7 (274.5) 180 ( - )
 Median (IQR) 76 (76, 76) 239 (197.8, 565.5) 223.5 (173.5, 329.3) 200 (140, 600) 180 ( - )
Sample size (trials with 2 armsa)
  (N=6) (N=35) (N=15) (N=22) (N=1)
 Mean (SD) 420.7 (175.0) 577.0 (808.8) 476.3 (606.1) 498.4 (320.8) 600 ( - )
 Median (IQR) 468 (341.5, 500) 376 (265, 530) 330 (100, 425) 409 (259.5, 677.5) 600 ( - )
 Sample size (trials with ≥3 armsa)
  (N=5) (N=20) (N=5) (N=7) (N=2)
 Mean (SD) 457.8 (498.2) 1124.0 (864.4) 850.0 (1271.8) 1199.1 (733.5) 109.5 (48.8)
 Median (IQR) 189 (50, 1000) 1200 (283.5, 1770.5) 450 (100, 500) 1034 (750, 159) 109.5 (-)
  1. aA single drug with multiple doses that was placed under the same “Arm” in Interventions was considered as one arm
  2. SD standard deviation, IQR interquartile range