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Table 3 Characteristics of primary endpoints in clinical trials with non-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=68) Binary (N=255) Ordinal (N=71) Time-to-event (N=70) Other (N=16)
Time frame
 ≤14 days 35 (51.5%) 79 (31.0%) 39 (54.9%) 11 (15.7%) 5 (31.3%)
 15–30 days 26 (38.2%) 144 (56.5%) 30 (42.3%) 44 (62.9%) 8 (50.0%)
 >30 days 7 (10.3%) 32 (12.5%) 2 (2.8%) 15 (21.4%) 3 (18.8%)
Evaluation of clinical course
 Improvement - 61 (23.9%) - 53 (75.7%) -
 Worsening - 135 (52.9%) - 10 (14.3%) -
 Unknown - 59 (23.1%) - 7 (10.0%) -
Sample size (trials with 1 arma)
  (N=24) (N=57) (N=9) (N=16) (N=3)
 Mean (SD) 82.6 (99.8) 579.9 (634.8) 290.2 (219.3) 262.3 (303.4) 183.3 (104.1)
 Median (IQR) 60 (47.5, 60) 300 (136, 1000) 250 (90, 466) 150 (121, 202.5) 150 (125, 225)
Sample size (trials with 2 armsa)
  (N=27) (N=150) (N=44) (N=33) (N=9)
 Mean (SD) 730.5 (1675.1) 777.2 (1107.2) 336.8 (238.4) 464.6 (553.7) 1513.6 (2021.3)
 Median (IQR) 250 (101, 284) 400 (131.3, 1144.5) 300 (109.5, 480) 278 (100, 554) 1444 (100, 1728)
Sample size (trials with ≥3 armsa)
  (N=17) (N=48) (N=18) (N=21) (N=4)
 Mean (SD) 530.9 (990.9) 1225.2 (2347.2) 1481.1 (3228.3) 1034.2 (2223.6) 1042.5 (1431.5)
 Median (IQR) 200 (200, 200) 320 (200, 1480) 120 (120, 283.5) 320 (200, 676) 475 (247.5, 1270)
  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