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Table 1 Study characteristics

From: Drugs and convalescent plasma therapy for COVID-19: a survey of the interventional clinical studies in Italy after 1 year of pandemic

Study characteristics

All studies n=94

Study source

AIFA websitea n=66

ClinicalTrials.govb n=28

Primary purpose, n (%)

   

Treatment

86 (91%)

60 (91%)

26(93%)

Prevention

8 (9%)

6 (9%)

2 (7%)

Phase, n (%)

   

1

3 (4%)

3 (5%)

-

1/2

1 (1%)

1 (2%)

 

2

29 (34%)

20 (31%)

9 (43%)

2/3

19 (22%)

13 (20%)

6 (29%)

3

32 (38%)

26 (40%)

6 (29%)

4

1 (1%)

1 (2%)

-

Not reported

1

1

-

Not applicable

8

1

7

Sample sizec, n (%)

   

1-100

26 (30%)

14 (23%)

12 (46%)

101-1000

53 (60%)

39 (63%)

14 (54%)

>1000

9 (10%)

9 (14%)

-

Not reported

6

4

2

Study design

   

Single group

20 (22%)

9 (14%)

11 (39%)

Parallel group

69 (74%)

55 (85%)

14 (50%)

Cross over

1 (1%)

-

1 (4%)

Sequential

3 (3%)

1 (1%)

2 (7%)

Not reported

1

1

-

Randomization, n (%)

   

Yes

70 (76%)

55 (85%)

15 (56%)

No

22 (24%)

10 (15%)

12 (44%)

Not reported

2

1

1

Masking, n (%)

   

Yes

31 (33%)

25 (38%)

6 (21%)

No

62 (67%)

40 (62%)

22 (79%)

Not reported

1

1

-

Multicenter study, n (%)

   

Yes

74 (80%)

56 (88%)

18 (64%)

No

18 (20%)

8 (12%)

10 (36%)

Not reported

2

2

-

International study, n (%)

   

Yes

37 (40%)

31 (48%)

6 (21%)

No

55 (60%)

33 (52%)

22 (79%)

Not reported

2

2

-

Study sponsor, n (%)

   

Industry

32 (34%)

27 (41%)

5 (18%)

No industry

62 (66%)

39 (59%)

23 (82%)

  1. Characteristics of COVID-19 interventional clinical trials planned to be carried out in Italy, overall and by data source (update: 6 April 2021)
  2. aAIFA website [14]
  3. bClinicalTrials.gov [16]
  4.  cSample size, median (Interquartile range): overall, 243 (355), Study source: AIFA website, 285 (334); Study source: ClinicalTrials.gov, 149 (273)