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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)