Post-exposure prophylaxis against SARS-CoV-2 in close contacts of confirmed COVID-19 cases (CORIPREV): study protocol for a cluster-randomized trial

Tan, Darrell H. S.; Chan, Adrienne K.; Jüni, Peter; Tomlinson, George; Daneman, Nick; Walmsley, Sharon; Muller, Matthew; Fowler, Rob; Murthy, Srinivas; Press, Natasha; Cooper, Curtis; Lee, Todd; Mazzulli, Tony; McGeer, Allison

doi:10.1186/s13063-021-05134-7

Trials

Table 1 Schedule of events for the CORIPREV-LR trial

From: Post-exposure prophylaxis against SARS-CoV-2 in close contacts of confirmed COVID-19 cases (CORIPREV): study protocol for a cluster-randomized trial

Visit	Screening (day 0)	Baseline (day 1)	Day 7, ± 2 days	Day 14, ± 2 days	Day 35, ± 4 days	Day 90, ± 2 days
Visit format	Remote	Remote	Remote	Remote	In person	Remote
Eligibility assessment	X
Informed consent/assent	X
Cluster randomization	X^a
Dispensation of study drug (LPV/r arm)		X
Interview by study staff		X	X	X	X	X
Concomitant medication assessment		X	X	X	X	X
Adverse event assessment			X	X	X	X
Adherence diary (LPV/r arm)		Daily on d1–14
Symptom diary		Daily on d2–15, then d21, d28, d35
Temperature diary		Daily on d1–14
Visit-specific questionnaire^b		X		X	X	X
HIV self-test^c		X
Self-collected saliva sample		X	X	X	X
Self-collected oropharyngeal/nasal swab^d		X	X	X
Self-collected dried blood spot		X^e		X^f
Blood for SARS-CoV-2 serology		X^g			X
Stored blood samples					X
Blood for CBC					X^f

^aRandomization of the cluster occurs once all exposed contacts of an index COVID-19 case have provided their decision about study participation, or could not be contacted within 24 h of the study team becoming aware of the index case; once randomization has been completed then site coordinators should contact individual participants to conduct the baseline activities
^bSpecific components of each visit-specific questionnaire are listed in sections 13.3–13.7 below. Questionnaires can be completed on paper or via interview if internet access is unavailable. Guardians may complete questionnaires together with minors if preferred/not feasible by the minor
^c The HIV Self-test should only be done in participants over the age of 18 months; those under this age and those unable to perform the self-test for any reason (e.g., extreme needle phobia, limited manual dexterity) should undergo standard HIV testing at day 35 (HIV RNA test in those aged < 18 months; 4th generation antibody/antigen test for all others)
^dAn additional swab is to be collected within 24 h if symptoms develop before day 14. Two respiratory specimens (swabs, saliva, etc.) are to be taken at day 14 timepoint, unless an extra swab was already taken due to the development of symptoms in which case only one is collected
NB: other respiratory specimen(s) may be collected depending on availability of supplies
^eThe dried blood spot at baseline is to be performed in participants in the active arm only (since these participants are already collecting a drop of blood for the HIV self-test), for SARS-CoV-2 serology
^fThe dried blood spot at day 14 is to be performed in a random subsample of participants in the active arm only, for lopinavir levels. These participants are the only ones that require a CBC at day 35 since the hematocrit is required for interpretation of DBS lopinavir levels [42, 43]
^gBaseline serology is to be collected at baseline only if the participant is institutionalized

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ISSN: 1745-6215

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