Table 1.
At investigational site DAY 0 | At home from D 0 to D 6 | At investigational site D 7 (+2) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Visit | V0 screening/baseline | V1 efficacy evaluation | V2/ETTV final visit | ||||||||
Time | 0 | 1 min | 2 min | 5 min | 10 min | 15 min | 30 min | 60 min | 120 min | ||
Informed consent and personal data processing | X | ||||||||||
Demographic data and medical history | X | ||||||||||
Physical examination and vital signs | X | X | |||||||||
Previous treatments | X | ||||||||||
Concomitant treatments | X | X | X | ||||||||
Pregnancy test | X | ||||||||||
Rapid strep test | X | ||||||||||
Inclusion/Exclusion criteria | X | ||||||||||
URTI questionnaire | X | ||||||||||
TPA | X | X | |||||||||
STPIS | X | X | X | ||||||||
DSS | X | X | X | X | X | X | X | ||||
SwoTS | X | X | X | X | X | X | X | ||||
QuaSTI | X | X | X | ||||||||
Randomization | X | ||||||||||
Drug administration | X | X | |||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X | X |
STRRS | X | X | X | X | X | X | X | X | X | ||
Drug delivery | X | ||||||||||
Patient card delivery | X | ||||||||||
Patient diary delivery | X | ||||||||||
Patient diary collection and IMP return | X | ||||||||||
PSQ | X |
DSS = difficulty swallowing scale, IMP = investigational medicinal product, PSQ = patient satisfaction questionnaire, QuaSTI = qualities of sore throat index, STPIS = sore throat pain intensity scale, STRRS = sore throat relief rating scale, SwoTS = swollen throat scale, TPA = Tonsillo-Pharyngitis assessment, URTI = upper respiratory tract infection.