Table 2

Schedule of evaluation in the PRINCIPLE trial

Study period
ScreeningEnrolmentFollow-up
Days in study001–28 days29 days–onwards
Participant completes screening, eligibility and baseline questionnaire××
Clinician completes eligibility*××
Informed consent*××
Demographics, medical history and test results*§××
Concomitant medication×××
Randomisation×
Self-swab for SARS-CoV-2 testing×
Dispensing of trial drugs†××
Usual clinical care§×××
Daily questionnaire×
WHO-Five Well-Being Index×Days 14 and 28
SARS-CoV-2 serology test if available and obtainable×
Telephone interview: qualitative studyׇ
Adherence×
Adverse event assessments××
  • *Online or by phone.

  • †In trial drug arms only.

  • ‡For subset of patient participants.

  • §Retrospective data collection by study team.

  • PRINCIPLE, Platform Randomised trial of INterventions against COVID-19 In older peoPLE.