Table 2

Summary of document length and complexity for clinical trial patient information sheets and informed consent forms for clinical trials conducted during acute COVID-19 infection

TrialTotal wordsReading time (minutes)Flesch-Kincaid Grade Level*Gunning-Fog score†Flesch Reading Ease Score‡Average sentence length (words)
175 wpm (lower bound)240 wpm
(mean)
300 wpm
(upper bound)
Phase III platform trials
RECOVERY15598.96.55.29.912.255.220.5
REMAP-CAP368821.115.412.310.512.148.218
TACTIC-E568532.523.719.010.612.449.120.5
TACTIC-R499428.520.816.610.812.748.920.1
Phase III single agent commercial
GS-US-540-5773513929.421.417.19.110.657.819.4
RUXCOVID685539.228.622.99.210.455.018.5
SPRINTER546731.222.819.19.811.854.420.4
Phase II
ACCORD-2702640.129.323.410.011.954.619.1
COVASE354420.314.811.89.711.354.818.9
ILEAD-7462626.419.315.411.213.047.020.6
OSCAR GSK604634.525.220.29.311.656.516.3
SYNAIRGEN SG016645536.926.921.79.011.258.318.9
Theravance 0188446825.518.614.99.711.654.218
Overall
Median513929.421.417.19.811.854.619.1
  • *Range 0–18, higher score is more complex, recommended ≤6.

  • †Range 0–20, higher score is less readable, recommended ≤6.

  • ‡Range 0–100, 100 is best readability, recommended ≥60.