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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