Table 1 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Schedule of Events Timeline: enrolment, assessment of safety, assessment of efficacy and dispensing of the medicine
Study day | ||||
|---|---|---|---|---|
Procedures | Day 0 (day of randomisation) | 14 days after randomisation (study day 14)—participant contacted by phone | 28 days after randomisation (study day 28)—participant contacted by phone | Any hospital admission |
Consent | ✓ | |||
Eligibility check | ✓ | |||
Demographics | ✓ | |||
Medical history | ✓ | |||
Medication history | ✓ | ✓ | ✓ | ✓ |
Swab taken for COVID PCR test (if possible) | ✓ | |||
Randomisation | ✓ | |||
Dispensing of 14 day course of IMP (if randomised to IMP) | ✓ | |||
Medical notes/ePR/biochemistry results/microbiology results review | ✓ | ✓ | ||
Radiology review (if any performed on clinical grounds) | ✓ | ✓ | ||
Assessment of outcome measures (vital status, history of admission) (ePR/notes/death register/telephone call) | ✓ | ✓ | ✓ | |
Compliance assessment (telephone call) | ✓ | ✓ | ||
Study blood sampling (optional) | ✓ (serum sample + Tempus, EDTA) | ✓ | ||
Nasal brush (optional, for observational) | ✓ | |||
SAE/AE reporting | ✓ | ✓ | ✓ | ✓ |