Table 2

Standard Protocol Items: Recommendations for Interventional Trials table

ScreeningBaseline: day 0Days 1–21 (daily self- assessment)Day 5*Day 21
PhoneOnsiteParticipant’s homeOnsite
Informed consent procedureX†X‡
Eligibility check; inclusion and exclusion criteria
Oropharyngeal swabXPrompted by COVID-19 compatible symptoms**X
Laboratory-based serologyXX
RandomisationX
Administration of prophylaxis††XX
Daily self-assessmentX
Questionnaire on adherence of intervention‡‡§§X‡‡§§
Questionnaire on adverse eventsXX
Dried blood spot collection for blood drug concentrationX
Questionnaire on acceptabilityX
  • Participants who report COVID-19 symptoms on or prior to day 21; will have onsite visit as soon as possible. An oropharyngeal swab will be performed, and if SARS-CoV-2 is PCR-confirmed, participants will undergo a follow-up visit 14 days after symptoms onset.**

  • *Participants will be given the option of either a self-test dried blood spot, or home visit by a team member.

  • †Study information will be provided to participants by phone.

  • ‡Informed consent will be signed by participant and medical investigator onsite.

  • §Eligibility criteria will be checked with participant by phone.

  • ¶Eligibility criteria will be confirmed.

  • **Participants with a positive SARS-CoV-2 swab during follow-up will be provided with appropriate care, as per local protocol.

  • ††Only for participants randomised to lopinavir/ritonavir (LPV/r), as directly observed therapy for first dose.

  • ‡‡Only for participants randomised to LPV/r.

  • §§Only between baseline and day 5.